Monthly Archives: September 2022

Psoriasis is an immune-mediated skin disease with a genetic predisposition. There is an involvement of the interaction of adaptive and innate immunity, which is the main pathological mechanism in this disease. Cytokines, which are secreted, mediatethe interaction of the T cells with the cells of dendrites, keratinocytes, and macrophages [1]. Biologists over the past decade have developed and approved blockers for interleukinIL-23, tumour necrotic factor , and IL-17 for psoriasis treatment [2]. This disease is an immunesystems-related disease of joints and also of skin, which is recurrent, chronic, and common. It has a considerable huge negative impact on various aspects of an affected patient's health, like emotional, psychosocial, and physical well-being [2].

One of the main determinants of expression of the disease is the carriage of the HLA-Cw6 and environmental triggers such as beta-haemolytic infection caused by Streptococcus in the early stage of psoriasis, like if it begins before 40 years of age [3]. The cells that are antigen-presentingare present in the skin and secrete the IL-12 and IL-23, which ultimately activate type 1 (Th1) and type 17 (Th17)T helper cells to produce a cellular type of immune response. The cutaneous findings which are observed in this disease are due to the development of a state of chronic inflammation, altered hyperproliferation of epidermis, apoptosis, differentiated mechanism, and neo-angiogenesis which is caused by different types of cytokines such as tumour necrosis factor (TNF) [4].

There can be dysfunction in the immune systems, particularly in autoimmune diseases, which are caused by specific triggers that vary among individuals. Whereas in psoriasis, it most commonly may include trauma of the skin, like bites of insects, scratches, and sunburn. Stress can also be considered as one of the triggers. An inflammatory response is accidentally generated in the activated immune systemin psoriasis. The immune system works against or attacks the healthy cells as if they resemble foreign invading harmful pathogens. Here, signalling molecules are produced in excess, as well as the helper variant of T type of lymphocytes or T kind of cells, which are the white cells of blood, that becomeirregularly active. The blood vessels present in the skinwidendue to the action of cytokine molecules. So thereafter, there will be an accumulation of keratinocytes and white blood cells, which will in turn make the outermost skin layer grow much quicker than the normal one. In the usual scenario, a person without psoriasis would take up to 3-4 weeks for cell maturation, migration to the skin surface, dividing, and also sloughing off, whereas in psoriasis, for the same events, it takes just 3-7 days. The outcome of this is that there is a thick skin buildup with flushed, scale, skin, and plaques.

Psoriasis begins in one-third of the overall cases in childhood itself and is of long duration. It is acommonly occurring inflammation-related disorder of the layer of skin that is immune-mediated [5]. For the exacerbation and onset of the disease, there are numerous factors: mutations in the gene 14 of the recruitment of the caspase domain of the family and the genetic factor which has the HLA-Cw6; environmental factors like medications, lifestyle; and infectious diseases [6].

Some triggers like injury to the skin or medications like lithium, quinidine, antimalarial drugs, infections, and stress, cause most kinds of psoriasis. Allergies, weather, and diet too can be the other triggers for this condition. There are about seven main kinds of psoriasis: plaque-type psoriasis; Guttatepsoriasis; inverse psoriasis; pustular psoriasis; erythrodermic psoriasis; nail psoriasis; and psoriatic arthritis.

While identifying this disease, we look for its symptoms, which can appear like rashes occurring in patches and lookdifferent as we see them in each individual. Some may appear as major eruptions all over the body or dandruff-like scaling. It could also be rashes with variation in the colours like shades of brown or pink or black skin or grey with purple or even with red along with silver scaling on the white skin, or cracked skin due to dryness that might bleed, or scaling small spots usually occurring in children, burning sensation, soreness, the appearance of episodic rashes that would aggravate for some weeks or months and then eventually subside.

As we mentioned earlier, among the various kinds of psoriasis, plaque is one. It causes raised patches of skin covering scales, itchiness, and dryness, and it is the most common kind of psoriasis. Scalp, knees area, elbow, and lower back are the frequent occurring sites. Depending on the colour of skin, there is variation in the colour of patches. Particularly on brown or black skins, there might be temporary changes due to postinflammatory hyperpigmentation in the appearance of colour as an outcome of the healing of the altered part of the layer of skin.

In the other kind, we see nail psoriasis which causes abnormally grown nails with discolouration and pitting affecting the fingernails and toenails. The nails could loosen up and get separated from the nail bed in this, also called onycholysis, and if it gets severe, then the nails may even crumble.

Further, there is also Guttate and inverse psoriasis, wherein the prior one mainly affects children and among adults and is mainly triggered by any infection caused due to Streptococcus,which is a bacterial infection. It is identified by scaling spots all over the trunk or arms, and legs, which are small drop-shaped. Inverse psoriasis is another kind in which there is an occurrence of inflamed skin which appears in smooth patchwork and worsens with sweating and friction, and it commonly acts on the folding of the skin of the area of the groinor buttocks and also of breasts. This kind of psoriasis is usually triggered by fungal infections.

The very least occurring kind of psoriasis is the erythrodermic type psoriasis which may either be chronic, which is of longer duration, or acute, which is of short duration. It appears like a peeling form of a rash that can itch or burn covering the entire body surface.

A rare kind which can be defined as blisters with pus is pustular psoriasis. It can appear in the small area of the sole and palm or like widespread patches. The most clearly demarcated are the generalized pustular, palmoplantar, and acrodermatitis continua of Hallopeau among pustular psoriasis which is a heterogenous entity of different organ disease subtypes clinically. These are different from psoriasis vulgaris in phenotype and genetic ways but these subtypes may resemble to plaque psoriasis, establishing the rationale for the inclusion in the psoriasis band. As shown by the recent identification of mutation of three different kinds of genes, of the skin's innate immune systems, the genetic background is thought to be monogenic which is unlikely in psoriasis, the genes are IL36RN, CARD14 and AP1S3 [7]. Paradoxical psoriasis form of dermatitis is usually triggered by subtypes of generalized pustularsand its various kinds like acute pustulosis, acrodermatitis, pustular of palmoplantar, and different kinds of pustular of mostly a TNF-blocker. Table 1 gives the types of psoriasis [8].

The pustular type of psoriasis may be present as the generalized type in the form of recurrent illness which is systemic, or as in palmoplantar type in the form of a locally centred disease mainly affecting the sole and palm, or in acrodermatitis in the nail beds or its digits. The consequences and severity should not be ignored or taken lightly, although these types of conditions are rare. With the capability of life-harming complications like a medical emergency of generalized pustular type of psoriasis when it appears like an acute episode like a flare. Debilitating conditions can be seen in the palmoplantar pustular type of psoriasis and in the acrodermatitis continua of Hallopeau. While in acrodermatitis there may be irreversible damage to the bone or nail, whereas in palmoplantar pustular psoriasis there is health-wise-related impaired life quality and morbidity psychiatrically [9].

Fever and malaise generally are accompanied by a systemic type of inflammatory, chronic disease, that is the generalized pustular type of psoriasis. Multiple pustules which are sterile occur all over the body surface along with diffused erythema and extremities swelled up, in generalized pustular psoriatic patients. There can behealth-threatening situations as generalized pustular often reoccur in the lifetime. Clinicians and researchers are being provided with major advances in the approach towards the pathomechanism of generalized pustular understanding with the help of the underlying genetic molecular basis of different cases with recent discoveries. Figure 1 give the types of pustular psoriasis [10].

The discovered anomalies include an unusual gain of the function of mutations in gene encoding around keratinocyte signalling molecule CARD14 and a loss-of-function mutation in the interleukin 36 receptor antagonist gene. Neutrophils and interleukin 36 (IL-36) are now recognised as key players in the pathogenesis of generalized pustular, with IL-36 signalling serving as a connecting link between the responses of innate and adaptive immune systems. Inflammation is now thought to be brought on by an aberrant innate immune response that is primarily genetically determined and results in an inflammatory kind of keratinization. Currently, generalized pustular is regarded as a representative of this newly discovered class of skin disorders known as autoinflammatory keratinization disease [11].

Retinoids, or methotrexate, or cyclosporine, also corticosteroids, or TNF-alpha inhibitors, topical therapy, and phototherapy are amongless well-established treatments. TNF-alpha inhibitors should be used in conjunction with methotrexate to prevent the development of antidrug antibodies [12].

Around 20% of patients referred to the early arthritis clinic have psoriatic arthritis, which is difficult to diagnose and treat. For the prevention of the function loss occurring long term and also to assure the best arthritis management and important comorbidities, early diagnosis is crucial. The differential diagnosis for a rheumatologist includes rheumatoid arthritis, also gout, including various inflammatorily arthritides. Once the condition has been identified, it is critical to thoroughly evaluate it, looking for signs of arthritis, or enthesitis, or dactylitis, or skin/nail disease, and also axial involvement [13].

Psoriatic arthritis is a chronic, autoimmune-mediated, inflammatory arthropathy that affects the joints and entheses, particularly those of the axial skeleton. It is associated with an increased risk of cardiovascular disease mortality [14].

Cytokine inhibitors, particularly those specific for tumour necrosis factor and, more recently, the interleukin 23-T-helper-17 cell pathway, have been very successful in the treatment of disease manifestations in a variety of tissues, even though targeting the interleukin 23-T-helper-17 cell pathway may be more effective in treating psoriasis than arthritis [14].In Western adults, it is prevalent at 2-4%, and psoriatic arthritis develops in 20-30% of psoriasis sufferers [15]. This illness affects several organ systems, including skin, nails, entheses, peripheral and axial joints, and nails. Osteoporosis, or uveitis, or subclinical intestinal inflammation, and also cardiovascular disease are all associated with psoriatic arthritis as comorbidities. Its heterogeneity has made diagnosis challenging. Here, we review its classification criteria in an updated manner. CASPAR, which stands for Classified Criteria for Psoriatic Arthritis, type of screening instruments are used to help in quick diagnosis, recent discoveries on aetiology, and new therapy modalities, which also include biological drugs [15].

Historically, non-steroidal anti-inflammatory drugs and the same old medicines that treat rheumatic diseases were used to treat psoriatic arthritis patients. Although their ability to halt the radiological development of joint disease is not established. Contrarily, anti-tumour necrotic factor medications such as certolizumab, or etanercept, or infliximab, or adalimumab, and also golimumab are considered in this aspect. Apremilast, an orally taken phosphodiesterase 4 inhibitor, tofacitinib, a Janus kinase inhibitor, and numerous new biologics that target the IL-23 and IL-17 pathways, such as secukinumab, or brodalumab, or ixekizumab, and also ustekinumab, are among the latest psoriatic arthritis medications [16].

Evidence suggests nutrition performs a significant aspect in the aetiology of psoriasis which is growing, among other psoriasis risk factors. In particular, diet, nutrition, and body weight may worsen or possibly start the disease's clinical signs [17]. There are a number of reasons that could account for the elevated frequency of cardiovascular events in the psoriasis population. The high prevalence of traditional cardiovascular risk factors and metabolic disorders are the main contributors to the significant cardiovascular burden in psoriasis patients. Similarly, the coexistence of systemic inflammation and metabolic disorders may raise the risk of cardiovascular disease in these people [18].

Psoriasis vulgaris is the most well-known and manageable human disease that is mediated by T lymphocytes and dendritic cells. Inflammatory myeloid dendritic cells release IL-23 and IL-12 to encourage IL-17-producing T cells, Th1 cells, and Th22 cells to produce significant amounts of the psoriatic cytokines IL-17, IFN (interferon), TNF, and IL-22 [19]. Patients with this genotype have been observed to have distinct clinical characteristics and acquire the disease at an earlier age, with a concordance of about 60% in monozygotic twins. HLA-Cw*0602 is a substantial risk factor for the beginning of the illness, and homozygous people are also at risk, according to recent linkage and higher resolution association studies.

Compared to heterozygotes, they have a disease risk that is around 2.5 times higher for this gene. According to published evidence, (cells of differentiation) CD8+ T cells may be a key effector in psoriasis. A notable characteristic of persistent psoriasis lesions is epidermal infiltration of oligoclonal CD8+ T cells, which are reacting to particular antigens, and likely also of CD4+ T cells in the dermis [20].

Local treatments, or phototherapies, and also systemic treatments like standard systemic therapy and biotherapy, are all currently available and, in the major part of the cases, are sufficient to control this skin condition. So as to improve these children's lifetime, subsequent management should concentrate on preserving therapeutic efficacy and preventing recurrence by minimising any of it [21].

Hydration of skin like frequent use of moisturisers and emollients, careful, and gentle skin cleaning, detection and avoidance oftriggers related to the phenomenon of Koebner like excoriation, maceration, and foci which are infectious are all important parts of treating psoriasis (Streptococcus pyogenes). Patients with psoriasis have shown that moisturisers considerably reduce their skin problems and enhance their quality of life. Due to the prevalence of dry skin, which increases the irritation of sick skin, they are an effective first-line treatment [22].

Newer topical treatments like calcipotriol and immunosuppressive medications like cyclosporin A and FK506 are significantly changing how psoriasis is treated [23]. Up until recently, corticosteroids, tars, anthralins, and keratolytics were the cornerstones of topical therapy. However, recently, topical retinoids, a novel anthralin preparation, and vitamin D analogues have increased doctors' treatment toolkits [24].

The topical management of psoriasis requires the use of emollients, moisturisers, and keratolytic medications. They serve as adjuvants to conventional therapies and aid in lowering the scale load of particular patients. Emollients and moisturisers primarily function to support proper hyperproliferation, or differentiation, and apoptosis; additionally, they have anti-inflammatory actions, for instance through physiologic lipids [25].

Upper respiratory tract infection is the most common reason for asthma in children. Treatment is determined based on the disease's severity and whether or not it has affected any joints. Corticosteroids and calcipotriene are examples of topical treatments. Systemic retinoids, ultraviolet radiation, and cyclosporine all reduce cutaneous psoriatic lesions. Both the cutaneous and joint symptoms of psoriasis respond well to methotrexate sodium and etanercept [26]. People with more severe, persistent, or extensive psoriasis can benefit from systemic medications, phototherapy, and other treatments. Although these treatments are more efficient than topical ones, they are also linked to serious cutaneous and systemic side effects [27].

UVB, that is ultraviolet B phototherapy, is a successful treatment for the widespread disease that allows for both quick management and long-term maintenance [28]. While cyclosporine is helpful, especially when used briefly in acute exacerbation situations, it should be substituted by other treatments for long-term maintenance [28].Lower concentrations and shorter durations of topical corticosteroids should be prescribed for treating children. Patients who are pregnant or nursing can benefit from topical corticosteroids in a safe and efficient manner. They are available in many different formulations, including shampoos, ointments, creams, lotions, gels, foams, and oils [29]. Although topical steroids are often used, there are only a few disorders that have been proved to benefit from their usage, such as psoriasis, vitiligo, eczema, atopic dermatitis, phimosis, acute radiation dermatitis, and lichen sclerosus [30].

The likelihood of psoriasis symptoms improving appears to be higher for foods and substances with systemic anti-inflammatory properties [31]. When combined with topical or systemic therapy, a low-calorie diet (LCD) improves the Dermatology Life Quality Index and Psoriasis Area and Severity Index. However, LCD was not successful in maintaining disease remission when patients stopped concurrent cyclosporine or methotrexate therapy [32]. Psoriasis patients usually have an imbalanced diet, with a higher consumption of fat and a lower intake of fish or dietary fibre, as compared to controls. Such dietary habits may have an impact on the frequency and intensity of psoriasis. Nutrition has an impact on the start, progression, and comorbidities of psoriasis [33].Body mass index and psoriasis severity have been linked in various studies, and obesity has been linked to a pro-inflammatory condition [34].

When it comes to the safety and effectiveness in patients having covid vaccine with immune-mediated inflammatory diseases (IMIDs), there is little reason to believe that these patients face any higher risk of negative side effects than healthy controls [35].Because of the elevated risk of infection, especially in high-risk areas, conventional immunosuppressive medications like methotrexate and cyclosporine, as well as anti-TNF drugs, should not be recommended. The side effect of hypertension, which has been linked to a higher likelihood of developing severe COVID-19 (coronavirus disease), may make using cyclosporine riskier. Given the lack of conclusive evidence to date that biologics increase the risk of COVID-19, these drugs should only be stopped when a patient displays COVID-19 symptoms [36].Due to the COVID-19 pandemic, clinicians treatingIMIDs, such as psoriasis, have encountered significant challenges. Patients with severe psoriasis are more likely to have obesity, hypertension, diabetes, and male sex as risk factors for severe COVID-19. The risk of severe infection is also known to increase with the use of several systemic psoriasis treatments. Therefore, it makes sense that in the early stages of the pandemic individuals receiving typical targeted systemic medication were believed to have a greater chance of getting a severe COVID-19 infection. In addition to risk-reducing behaviours like social distance suggested by the World Health Organization, people who were deemed to be more sensitive, such as those using immunosuppressants, were encouraged to adopt greater measures of social isolation [37]. The COVID-19 pandemic negatively affects the treatment of psoriasis and the provision of healthcare [38]. Patients with psoriasis who have had biological treatment or another sort of systemic therapy may develop a mild case of SARS-CoV-2(severe acute respiratory syndromecoronavirus 2) infection, while they may also briefly experience an aggravation of skin lesions [39].

Read more here:
Types of Psoriasis and Their Effects on the Immune System - Cureus

MoonLake Immunotherapeutics to initiate global Phase 2 studyofthe Nanobody sonelokimabin patients with active psoriatic arthritis

ZUG, Switzerland, September 26, 2022 MoonLake Immunotherapeutics AG (MoonLake), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced U.S. Food and Drug Administration (FDA) clearance for a Phase 2 clinical study of the nanobody sonelokimab in patients with active psoriatic arthritis (PsA). This is a global clinical study that also includes several European countries.

This new study is subsequent to the completion of a global Phase 2b study in moderate-to-severe psoriasis (NCT03384745) and the initiation of the Phase 2 MIRA study in moderate-to-severe hidradenitis suppurativa (NCT05322473).

The global, randomized, double-blind, placebo-controlled study (M1095-PSA-201, ARGO) is designed to evaluate the efficacy and safety of different doses of sonelokimab compared to placebo, with adalimumab as an active reference arm, in approximately 200 patients with active PsA. The primary endpoint of the study is the American College of Rheumatology (ACR) 50 response defined as the percentage of participants achieving 50% improvement in signs and symptoms of disease from baseline, compared to placebo. This study is the first in PsA to use the Nanobody.

The study will also include a range of secondary endpoints reflecting the heterogeneous and multi-faceted nature of the disease, including the assessment of skin clearance (including Psoriasis Area and Severity Index (PASI) 100), disability, enthesitis, pain, as well as other levels of ACR response (including ACR70). Patient enrollment is expected to begin in 2022, with the first sites being initiated in Europe and in the United States.

Sonelokimab (M1095) is an investigational Nanobodydesigned to treat inflammatory disease by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. In addition, sonelokimab is designed to directly target sites of inflammation and penetrate difficult-to-reach inflamed tissues.

Kristian Reich,Co-founder andChief Scientific Officer at MoonLake, said: The initiation of the ARGO study represents an important milestone in the development of the IL-17A and IL-17F inhibiting Nanobody sonelokimab for the treatment of inflammatory skin and joint conditions. I am particularly excited to see how the small size and albumin-binding properties of sonelokimab will further elevate the anti-inflammatory potential of IL-17A and IL-17F inhibition to improve treatment outcomes across various disease domains of PsA including arthritis, enthesitis and psoriasis.

-ends-

About the ARGO studyThe ARGO study (M1095-PSA-201) is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of the Nanobodysonelokimab, administered subcutaneously, in the treatment of adult patients with active psoriatic arthritis. The study will comprise approximately 200 patients, and will evaluate different doses of sonelokimab, with placebo control and adalimumab as an active reference arm. The primary endpoint of the study is the percentage of participants achieving 50% improvement in signs and symptoms of disease from baseline, compared to placebo, as measured by the American College of Rheumatology (ACR) 50 response. The study will also evaluate a number of secondary endpoints, including improvement compared to placebo in ACR70, complete skin clearance as measured by at least a 100 percent improvement in the Psoriasis Area and Severity Index (PASI100), physical function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI), enthesitis as measured by the Leeds Enthesitis Index and pain as measured by the Patients Assessment of Arthritis Pain (PtAAP).

About MoonLake ImmunotherapeuticsMoonLake Immunotherapeutics AG is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The companys focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at http://www.moonlaketx.com.

About NanobodiesNanobodies represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and the ability to design multivalent therapeutic molecules with bespoke target combinations.

The terms Nanobody and Nanobodies are trademarks of Ablynx, a Sanofi company.

About SonelokimabSonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody consisting of three VHH domains covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema.

Sonelokimab has been assessed in a randomized, placebo-controlled Phase 2b study in 313 patients with moderate-to-severe plaque-type psoriasis. Sonelokimab demonstrated a rapid and durable clinical response (Investigators Global Assessment Score 0 or 1, Psoriasis Area and Severity Index 90/100) in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575).

In an earlier Phase 1 study in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196203). Recently, a phase 2 trial in hidradenitis suppurativa (NCT05322473, M1095-PSA-201,MIRA) including multiple arms and over 200 patients has been initiated (announced on May 5, 2022).

Sonelokimab is not yet approved for use in any indication.

About Psoriatic ArthritisPsoriatic arthritis (PsA) is a chronic and progressive inflammatory arthritis associated with psoriasis primarily affecting the peripheral joints. The clinical features of PsA are diverse, involving pain, swelling, and stiffness of the joints, which can result in restricted mobility and fatigue.PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. The symptom burden of PsA can have a substantial negative impact on patient quality of life. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology.

Cautionary Statement Regarding Forward Looking StatementsThis press release contains certain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLakes expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: plans for preclinical studies, clinical trials and research and development programs; and the anticipated timing of the results from those studies and trials. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words anticipate, believe, continue, could, estimate, expect, intend, may, might, plan, possible, potential, predict, project, should, would and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking.

Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLakes business in general and limited operating history, difficulty enrolling patients in clinical trials, and reliance on third parties to conduct and support its preclinical studies and clinical trials.

Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based.

MoonLake Immunotherapeutics InvestorsMatthias Bodenstedt, CFOinfo@moonlaketx.com

MoonLake Immunotherapeutics MediaPatricia Sousap.marquesdesousa@moonlaketx.com

Matthew Cole, Mary-Jane ElliottConsilium Strategic CommunicationsTel: +44 (0) 20 3709 5700media@moonlaketx.comMoonLake@consilium-comms.com

Read more:
MoonLake Immunotherapeutics to initiate global Phase 2 study of the Nanobody sonelokimab in patients with active psoriatic arthritis - BioSpace

Healthcare is an area where diversity and inclusion (D&I) can directly affect a persons quality of life and treatment outcomes. Recently in the field of dermatology, a focus on D&I is helping to redress historical bias and open avenues of research, bringing benefits to patients and healthcare systems alike.

Historically, medical textbooks have described skin symptoms in Caucasian-dominated language, based on lighter skin tones causing diagnosis and treatment disparities, with patients with darker skin tones being under-diagnosed and under-treated.1 Today, medical education programmes are rewriting textbooks, materials, and trainings to bridge this knowledge gap and reduce the chances of skin colour impacting accurate diagnosis and treatment. The British Association of Dermatologists highlighted the issue, noting that descriptors for rashes and lesions have been based on people of European ancestry.2 It observed that it is vital that the language used for describing rashes/lesions in dermatology is updated, to be inclusive and reflective of the UKs ethnic diversity. Demand is clear: a new clinical handbook of signs and symptoms in black and brown skin called Mind the Gap, has been viewed online more than 100,000 times.3

Janssen, as part of the pharmaceutical companies of Johnson & Johnson, has a 130-year heritage in healthcare. As we rise to the call to help address historical inequities, we are proud to take a multi-faceted approach which includes the active embedding of D&I principles throughout our organisation. In immunology, were reframing clinical trials, drug development, and support networks for patients suffering with chronic skin conditions and other diseases. D&I must be integral to beliefs and behaviours to be truly transformative in healthcare.

Dr Mehbub Shafi, Medical Advisor at Janssen-Cilag Ltd, notes changes seen since his medical training: Dermatological conditions affect patients of all skin tones, but symptoms can manifest differently, he says. While lack of awareness of these differences may have been an issue in the past, I can see that things are improving.

A clear example can be seen in psoriasis, an incurable chronic condition affecting 1.8 million people in the UK, 14 million Europe-wide and 125 million globally.4,5,6 The effects can be both physically and psychologically scarring. Research has shown that 37% of psoriasis patients experienced suicidal thoughts, while the impact on family members is evidenced by 37% of close relatives and partners reporting their relationships suffered because of the condition.7,8 Every aspect of life is impacted for example, people with psoriasis miss an average of 306 hours of work per year, more than eight weeks based on a 7.5-hour work day.9

Dr Shafi notes: There is the medical aspect, which is huge, but the psychological and psycho-social aspects are important too because patients living with a dermatological disease often have a higher incidence of mental health issues. Addressing diversity and inclusivity to achieve optimal treatment is pivotal in improving outcomes for patients with darker skin tones.

Diversity is relevant not just in psoriasis diagnosis, but also in treatment where, for example, higher doses of phototherapy may be needed for darker skin.10 Janssens UK medical education programme, aimed at and targeted to dermatologists across the UK, has focussed specifically on diversity and skin of colour. Janssen is also actively working with the UK dermatological community to develop resources supporting diagnosis and treatment in diverse communities,through partnerships with patient advocacy groups and patient advisors to ensure materials are tailored to diverse patient needs.

When it comes to decision-making in dermatological R&D, Janssen works with patients to enshrine the patient voice. This helps us deliver on the Johnson & Johnson credo: our first responsibility is to patients, doctors and nurses, followed by our responsibility to the communities in which we live and work, and then the global community, says Dr Shafi.

In addition to supporting better access to care, we are also raising awareness in the healthcare community about important issues in the diagnosis and treatment of diverse or under-represented groups. It is important to gain feedback from patients living with psoriasis and healthcare professionals, understanding their concerns and then implementing and driving activities that will have an impact.

At Janssen, the patient voice is central to pursuing novel research and improving therapies, to support work to stop and even cure dermatological diseases. Janssen will continue working with patients and experts to promote health equity for all as we work towards our mission to redefine treatments for dermatological diseases by delivering transformational and accessible therapies.

For more information, please visit http://www.janssen.com/uk

References

1 Takeshita J, Gelfand JM, Li P, et al. Psoriasis in the US Medicare Population: Prevalence, Treatment, and Factors Associated with Biologic Use. J Invest Dermatol 2015; 135(12): p2955-2963

2 British Association of Dermatologists. Improving Descriptors in Dermatology. Available at: https://www.bad.org.uk/healthcare-professionals/inclusivity-and-representation/descriptors-in-dermatology. Last accessed: September 2022

3 Dhillon R, Booth AJ & Mukwende M. Mind the Gap. British Dental Journal 2021; 230(273)

4 Psoriasis Association. About Psoriasis. Available at: https://www.psoriasis-association.org.uk/about-psoriasis. Last accessed: September 2022.

5 Augustin M, Alvaro-Gracia JM, et al. A framework for improving the quality of care for people with psoriasis. Psoriasis White Paper. JEADV 2012; 26(4): p1-16

6 National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Last accessed: September 2022

7 Pompili M, Innamorati M, et al. Suicide risk and psychiatric comorbidity in patients with psoriasis. Journal of International Medical Research 2016; 44(1): p6166.

8 Eghlileb A, Davies E and Finlay A. Psoriasis has a major secondary impact on the lives of family members and partners. British Journal of Dermatology 2007; 156(6): p124550.

9 Mustonen A, et al. How much of the productivity losses among psoriasis patients are due to psoriasis. BMC Health Services Research 2015; 15(87)

10 National Psoriasis Foundation. Psoriasis and skin of color. 2021. Available at: https://www.psoriasis.org/advance/diagnosing-psoriasis-in-skin-of-color/. Last accessed: September 2022

Dr Mehbub Ali Shafi is Medical Adviser, Dermatology, The Janssen Pharmaceutical Companies of Janssen-Cilag Ltd.

* EM-80125 | September 2022

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How diversity and inclusion continues to be incorporated in dermatology - PMLiVE

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Arcutis Announces Topline Results From ARRECTOR Pivotal Phase 3 Trial Of Roflumilast Foam 0.3% In Scalp A - Benzinga