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Category Archives: Psoriasis

Psoriasis sensor gets under peoples’ skin – New Atlas – New Atlas

Posted: June 1, 2017 at 10:12 pm

RSOMtech uses lasers to generate ultrasound waves beneath the skin's surface (Credit: Helmholtz Zentrum Mnchen)

When doctors assess the inflammatory skin disease psoriasis, they generally do so via a visual examination of the red, scaly patches on the skin's surface. This can be subjective, however, plus it doesn't take into account what's going on at a deeper level. That's why German scientists from Helmholtz Zentrum Mnchen and the Technical University of Munich have developed a handheld scanner that looks beneath the skin and it doesn't expose the patient to any harmful radiation.

Known as RSOM (raster-scan optoacoustic mesoscopy), the technology incorporates weak laser pulses that are used to slightly heat the tissue being examined. This causes the tissue to momentarily expand, which in turn generates ultrasound waves. The sensor is able to detect those waves, and analyzes them to create a high-resolution image of what's happening under the skin.

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In lab tests performed on psoriasis patients, RSOM allowed the scientists to determine individuals' skin thickness, capillary density, number of blood vessels, and total blood volume in the skin. Down the road, it's possible that the system could also be used to assess diseases such as skin cancer or diabetes.

"This technology, which is easy to use and does not involve any radiation exposure or contrast agent, is allowing us to acquire the first new insights into the disease mechanisms," says Prof. Dr. Vasilis Ntziachristos, Director of the Institute of Biological and Medical Imaging at the Helmholtz Zentrum Mnchen, and Chair of Biological Imaging at the Technical University of Munich. "It also facilitates treatment decisions for the physicians."

A paper on the research was recently published in the journal Nature Biomedical Engineering.

Source: Helmholtz Zentrum Mnchen

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Arthritis news: Drug could treat condition linked to psoriasis – Express.co.uk

Posted: May 30, 2017 at 2:00 pm

GETTY

A new drug for psoriatic arthritis has shown promise in a clinical trial.

The study by Stanford University found that it significantly reduced symptoms for sufferers.

These include joint tenderness and swelling.

Previously, standard pharmaceutical treatments had provided no effective or long-lasting relief.

GETTY

The findings are particularly important given that if left untreated, or treated unsuccessfully, the condition can develop into severe joint and bone damage and functional disability.

Researchers discovered that the biologic drug, ixekizumab, resulted in more than half of participants experiencing at least a 20 per cent reduction in the number of tender and swollen joints.

It also significantly out-performed the placebo.

In the study, the researchers looked at over 300 adults, for whom standard drugs were no longer working or never worked.

The findings are particularly important given that if left untreated, or treated unsuccessfully, the condition can develop into severe joint and bone damage and functional disability.

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About one in 200 adults in developed countries suffers from psoriatic arthritis.

The condition causes inflammation in and around the joints, according to Arthritis Research UK.

Symptoms usually appear between the ages of 30 and 50.

It usually affects those who already have psoriasis.

GETTY

The common skin condition causes red, scaly rash, especially on the elbows, knees, back, buttocks and scalp.

While the ultimate cause of the disease remains unknown, inflammation is the trigger.

A third of people will have a mild form of the disease that remains stable.

However others will have symptoms which need long-term treatment.

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Psoriasis: What can GPs do to deliver optimal care? – GP online

Posted: at 2:00 pm

A new report has highlighted a severe lack of dermatology training and support within primary care. Dr Angelika Razzaque outlines the report's findings and what they mean for GPs.

A new report from the Patients Association, in partnership with LEO Pharma, has highlighted the severe lack of dermatology training1 and specialist support2 available for GPs.

Research shows that nearly a quarter of the population have sought GP advice on skin matters in England and Wales,2,3 yet some doctors have received just five days of dermatological training.1 There are only 650 dermatology consultants nationally to support them.2

The PSO What? initiative is a partnership programme led by The Patients Association and LEO Pharma, in collaboration with the expert PSO What? Taskforce. The PSO What? report highlights the need for better education and understanding surrounding the burden psoriasis places on individuals.

Psoriasis is one of several dermatological conditions where patient outcomes may be compromised by a lack of knowledge within primary care.

This condition affects over 1.8m people in the UK4 and it is essential to ensure tailored and holistic care to effectively manage the principal psoriasis symptoms, and also to reduce the risk of associated comorbidities.

The PSO What? Report takes a positive step forward in this direction. Developed in collaboration with an expert taskforce of healthcare professionals, patients and charities of which I am proud to be included - the report highlights that while GPs in the UK can handle around 13m appointments about skin conditions every year,2 no region in England has enough dermatology consultants when compared with recommendations from the Royal College of Physicians.2

Psoriasis needs higher prioritisation on health agendas, and stakeholders must respond by addressing the lack of practical dermatological training and formal assessment on educational curricula.

Beyond this, we as GPs should move away from the misconception that psoriasis is just a skin condition, and instead look for the best possible whole-person care for each individual.

A third of psoriasis patients surveyed as part of the PSO What? report do not regularly visit their GP each year.5 This is particularly concerning given people with psoriasis can also be at risk of developing other serious comorbidities6 including psoriatic arthritis,6 cardiovascular disease,7,8,9 metabolic syndrome,10 inflammatory bowel disease,6 complications with vision11 and some cancers.12

Aside from the physical aspects, the mental health of psoriasis patients should be taken into account. More than 10,000 diagnoses of depression and over 7,000 diagnoses of anxiety in the UK are attributable to psoriasis each year.13

General practice is a specialism of its own; our unique role in assessing the whole patient and addressing multiple comorbid conditions means that we are best placed to anticipate, prevent and manage associated conditions so that the broader burden of psoriasis can be reduced.

Given the right access to appropriate treatments and information, most people with psoriasis can be principally managed in partnership with GPs, nurses and pharmacists. By better educating GPs, we can ensure that appropriate patients are referred onto secondary care and primary care clinicians are confident in psoriasis diagnosis and treatment decision-making.

By reviewing our patients regularly, at least once a year, we have the opportunity to improve outcomes as well as helping to reduce life-limiting psoriasis complications and the potential burden on the NHS down the line.

The report calls for people from all walks of healthcare from universities, to GPs, consultants, payers and policymakers - to pledge their personal and professional support to drive real change by visiting http://www.PSO-What.com.

However, this will only prove effective if those in primary care are given the training and support required to confidently manage and treat the physical manifestations of psoriasis, as well as its associated complications and psychological effects.

To read the report and to pledge your support visit http://www.PSO-What.com.

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Biosimilars Market Access in Psoriasis 2017: TNF-alpha inhibitors Enbrel, Humira, and Remicade have Long Held … – GlobeNewswire (press release)

Posted: at 2:00 pm

May 30, 2017 05:15 ET | Source: Research and Markets

Dublin, May 30, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Biosimilars Market Access in Psoriasis" report to their offering.

Tumor necrosis factor (TNF)-alpha inhibitors Enbrel, Humira, and Remicade have long held dominant positions in the psoriasis market; however, these market leaders face patent expirations and consequent biosimilar launches.

Payers are eager to leverage these changes in the competitive landscape and enact pro-biosimilar access measures, resulting in downward pricing pressures and/or continuing market erosion for first-generation TNF-alpha inhibitors. This rate of erosion may initially be gradual, as neither physicians nor payers are likely to advocate patient switching.

Key Topics Covered:

1. Executive Summary

2. Five Major EU Markets

3. Methodology

For more information about this report visit http://www.researchandmarkets.com/research/7tcv43/biosimilars

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Biosimilars Market Access in Psoriasis 2017: TNF-alpha inhibitors Enbrel, Humira, and Remicade have Long Held ... - GlobeNewswire (press release)

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Ask The Expert: How do I deal with my teenage son’s psoriasis? – the Irish News

Posted: at 2:00 pm


the Irish News
Ask The Expert: How do I deal with my teenage son's psoriasis?
the Irish News
Q: "My teenage son has psoriasis and it's making his life a misery. What's the best way of dealing with it?" A: Consultant dermatologist Dr Anthony Bewley says: "Psoriasis isn't just a skin condition I see a lot of patients who struggle physically ...

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An Eye psore- A Clinical Relationship Between Psoriasis and Uveitis – Medical News Bulletin

Posted: at 2:00 pm

A new study conducted byShu-Hui Wang and colleagues looks to examine the relationship between psoriasis and uveitis.

Psoriasis and psoriatic arthritis can lead to inflammation of the eyes, a condition termed uveitis (pronounced you-vee-EYE-tis), a disorder that affects approximately one in 1000 Americans. A nationwide cohort study that examined nearly 147 954 Han Chinese individuals with psoriasis including more than 10,107 with concomitant psoriatic arthritis, 137 847 without psoriatic arthritis and 147 954 matched non-psoriatic controls found that there was a higher incidence of uveitis in individuals with psoriasis, irrespective of whether they had psoriatic arthritis, compared to the controls.

Psoriasis is a systemic and chronic disease that is mediated by an immune system gone awry in combination with various genetic and environmental factors. Psoriasis is not restricted to the skin and epidemiological studies show that psoriasis is associated with an increased risk of mortality and morbidities. Activation of T cells and consequently, that of inflammatory cells in the skin promote the proliferation of keratinocytes and epidermal hyperplasia. Pro-inflammatory cytokines released by T cells, including TNF, IL-2 and Interferons induce an inflammatory cascade. Medications such as efalizumab and alefacept as well as anti-TNF drugs such as infliximab, etanercept and adalimumab are used to treat and control psoriasis.

Uveitis is a condition characterized by intraocular inflammation with about 40% being secondary to an immune-mediated disease and 30% not fitting into any well-defined etiology. Development of uveitis shows genetic predisposition with a strong link between uveitis and a locus on chromosome 9. Studies show that Th17 and Th1 immune responses are involved in the immunopathogenesis of the disease, with IL-17 and TNF levels being particularly high in the aqueous humor of patients with uveitis.

Patients with psoriasis are more likely to get uveitis than the average individual and strikingly, patients with psoriatic arthritis have a higher risk, with at least 7% developing uveitis. Very few studies have examined the ophthalmological pathologies associated with psoriasis and studies that have evaluated the association, particularly in the case of uveitis, are largely inconclusive due to contradictory findings. To put to rest such conflicts, Shu-Hui Wang and colleagues at the Far Eastern Memorial Hospital in Taiwan identified psoriatic patients from a specialized dataset that contained all people with psoriasis from 2000 to 2011 in the National Health Insurance Research Database, with controls selected from the 2005 Longitudinal Health Insurance Database that provided longitudinally linked anonymized data of 1 million enrollees. Using univariate and multivariate Cox proportional hazard models to estimate the hazard ratios and 95% confidence intervals for the association between statusof psoriasis and uveitis occurrence, the primary outcome of interest, Shu-Hui Wang and colleagues demonstrated that patients with psoriasis and psoriatic arthritis had 160.88 incidences of uveitis per 100,000 person-years, patients with psoriasis and without psoriatic arthritis had 103.99 incidences of uveitis per 100,000 person-years compared to 87.23 in the controls.

This study is at odds with another study examining a Turkish population which showed no relationship between psoriasis and uveitis. Limitations of the study include the possibility of misclassification of patients with psoriasis and psoriatic arthritis, those who were rated based on the severity of the disease, and the generalizability of the results since the population studied was Han Chinese. However, the results may serve as a guide for uveitis risk stratification among patients who present with a varied inflammatory profile and help patients to understand the risk and manifestations of uveitis.

Written By:Joseph M. Antony, PhD

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Promising Results for Drug to Fight Arthritis Linked to Psoriasis … – Arizona Daily Star

Posted: May 28, 2017 at 7:13 am

FRIDAY, May 26, 2017 (HealthDay News) -- A new drug might help ease the pain and disability of a form of arthritis often linked to psoriasis.

According to Stanford University researchers, psoriatic arthritis is an inflammatory joint disorder tied to an out-of-control immune response. The disease affects about one in every 200 people and is often accompanied by the autoimmune skin disorder psoriasis.

Psoriatic arthritis typically arises after the age of 30 and can bring stiffness, pain and swelling of the joints, leading to real disability if treatments don't help.

The new study focused on more than 300 adult patients across 10 countries. These patients were no longer seeing an effect from standard biologic drugs or had never experienced a benefit in the first place.

"Only about half of psoriatic arthritis patients who are given TNF inhibitors get better," study lead author Dr. Mark Genovese said in a Stanford news release.

So, his team tried out a newer drug called Taltz (ixekizumab), already approved to fight psoriasis. The study was funded by the drug's maker, Eli Lilly & Co.

Patients were randomly assigned to receive injections of either Taltz or an inactive placebo. Over 6 months, about one-third got Taltz injections every two weeks, another third received the placebo every two weeks, while the remaining third received alternate injections of Taltz and the placebo.

More than half (53 percent) of those treated with the drug experienced at least a 20 percent reduction in the number of tender and swollen joints, compared to about 20 percent of those receiving the placebo, said Genovese. He's a professor of immunology and rheumatology at Stanford University Medical Center.

One expert in psoriatic arthritis was encouraged by the findings.

Taltz "is another new option for patients with psoriatic arthritis," said Dr. Waseem Mir, a rheumatologist at Lenox Hill Hospital in New York City. "The data shown in this article supports that certain patients who do not do well with other biologics that are in the market for psoriatic arthritis will now have another option for treatment of their painful disease," he said.

One potential side effect of these immune-focused drugs is a heightened vulnerability to infectious disease. However, Genovese said there was little difference in this regard between people taking Taltz and those on a placebo.

The study was published online May 24 in The Lancet.

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Risankizumab Treats Psoriasis More Effectively Than Other Antibody Drug – Medical News Bulletin

Posted: at 7:13 am

A recent randomized phase II clinical trial demonstrates that risankizumab treats psoriasis, a chronic immune-mediated inflammatory skin disease, more effectively than ustekinumab.

Psoriasis, a chronic immune-mediated inflammatory skin disease, affects 2% of adults and is associated with a poor quality of life, obesity, hypertension, diabetes, hypercholesterolemia, and metabolic syndrome. Researchers suggests that interleukin-23 (IL-23), composed of a p19 and p40 subunit, plays a significant role in the disease by inducing and maintaining inflammatory cells. Current strategies include monoclonal antibodies aimed at the different subunits of interleukin-23, including ustekinumab and risankizumab. Ustekinumab targets the p40 subunit, which is also found in IL-12, and thus acts against both IL-23 and IL-12. In contrast, risankizumab only targets the p19 subunit and selectively inhibits IL-23 activity. Clinical studies have shown that both drugs are safe, well-tolerated, and effective in treating psoriasis patients.

A recent randomized phase II clinical trial compared the efficacy, onset, and duration of clinical response between the two drugs in patients with moderate-to-severe psoriasis. Patients were randomly assigned to receive either a single 18-mg dose of risankizumab at week 0, a 90-mg or 180-mg dose of risankizumab at week 0, 4, and 16, or a dose of ustekinumab at week 0, 4, and 16. Patients were subsequently followed for 32 weeks after the final injection (total trial period of 48 weeks). The primary endpoint was a 90% or greater reduction from baseline in the PASI or Psoriasis Area Severity Index, which is an evaluation of erythema (redness), scaling, and percentage of body-surface area affected. In addition, the authors investigated safety end points including severe and moderate adverse events.

At the end of the study, a 90% or greater reduction in PASI was observed in 73% of patients in the 90-mg risankizumab group and 80% of patients in the 180-mg risankizumab group, compared with only 40% of patients who received ustekinumab. This indicates that a 90 and 180-mg dose of risankizumab is more effective in treating psoriasis than ustekinumab. The authors also found that the onset of risankizumab was earlier than ustekinumab, and the benefits were sustained for longer. Also, patient reports and skin biopsies further suggest that risankizumab was more effective in treating psoriasis and its associated morbidities than ustekinumab.

In conclusion, the randomized phase II clinical trial demonstrates that risankizumab is superior to ustekinumab in treating psoriasis and its associated morbidities. The onset and duration of beneficial effects are more profound and longer with risankizumab treatment. Although two patients developed basal-cell carcinoma and one had an adverse major cardiac event with risankizumab; the study had a small sample size and short duration, making it difficult to assess safety profiles. Nonetheless, the study suggests that selective blockade of IL-23, via p19 subunit inhibition, is more effective in treating psoriasis than inhibition of both IL-23 and IL-12. Future studies are required to confirm these results, and to better assess the safety profile of risankizumab.

Written By:Haisam Shah, BSc

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Psoriasis treatment update: Woman discovers miracle cure in THIS natural cream product – Express.co.uk

Posted: May 23, 2017 at 10:23 pm

The woman was forced to wear lace gloves every day to work due to the crippling self-consciousness brought on by her psoriasis.

Pat Woodward, 60, an estate agent from Hampshire, suffered from psoriasis for over ten years.

Her hands were so sore and unsightly she would wear gloves to work.

However, she finally overcame the condition after finding a treatment when she least expected.

PAT WOODWARD

Pats hands are worst affected but she also has psoriasis on her legs and her scalp.

Having psoriasis on my hands affects every aspect of my life.

As obvious as it sounds, you need your hands for literally everything, from washing and dressing in the morning to eating, driving, typing or gripping a pen, and of course, for interacting with others.

Until very recently Pat would wear lace gloves to work, both for her benefit and also because she didnt want to make others feel uncomfortable.

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Resist the itch - Eczema is almost always itchy no matter where it occurs on the body and although it may be tempting to scratch affected areas of the skin, this should be avoided as much as possible

PAT WOODWARD

Psoriasis can be very painful and having my hand squeezed by an unsuspecting stranger was often excruciating, Pat said.

The gloves would hide the layers of white, peeling, flaking skin, often cracked where my palms and knuckles were so dry my skin had split open.

Pat battled with different treatments for years.

She tried creams, mainly steroidal creams, from her doctor, but when these failed to work she begged to try stronger treatments.

My self-esteem was at an all-time low and I had started to suffer from depression, Pat said.

Doctors prescribed anti-depressants and continued to look at possible treatment plans, including light therapy, whilst family and friends suggested remedies including turmeric soap and beeswax creams, but nothing worked for any length of time.

Pat even tried three cancer-fighting drugs that break down the immune system, Methotrexate,Cyclosporineand Stelara.

PAT WOODWARD

However, the side-effects were horrendous.

From palpitations and general sickness to bowel disruptions so severe I actually thought I had cancer, and painful mouth ulcers, I felt dreadful, Pat said.

After my last course of skin injections in 2016, I asked my doctor not to put me forward for anymore.

Pat resolved herself to misery until she came across the cure to her condition completely by chance.

I was at a clients valuing her property when she asked me about my gloves. I went through the usual rigmarole of explaining why and what for, and she suggested I try Oregon grape root on my skin.

Ive had my fair share of tips and suggestions from well-meaning friends and family, but Oregon grape root was new to me.

I was immediately hopeful when I tried the Body & Hand Wash because for the first time in a long time my skin felt clean.

PAT WOODWARD

I was really keen to see an improvement in my hands. I applied a thick layer of Serum on these and wore with gloves overnight.

Pat claims the serum was immediately soothing and by morning her hands felt less tight.

After a few days she started to notice a visible difference too, the skin was less angry looking and after about four weeks, the thick flakes of white skin had reduced significantly and the deeper cracks had almost healed.

Pat has been using the Oregon Skincare range of products, designed especially to help combat the symptoms of psoriasis. The range costs from 7.95 and is available from http://www.skinshop.co.uk.

Guttate psoriasis is a sub-type of the skin condition psoriasis which is characterised by flakey, itchy skin and cannot be cured - although creams can quell the condition.

The Dermatology Clinic London's Dermatologist Dr Daniel Glass advised these two lifestyle factors could bring about a flare-up.

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Galectin Therapeutics: Serendipity In Psoriasis, Strength In NASH … – Seeking Alpha

Posted: at 10:23 pm

Introduction

Galectin Therapeutics (NASDAQ:GALT) is a small biotechnology company based in Norcross, Georgia, focusing on the innovation of medicines that inhibit galectin molecules for the treatment of various diseases such as nonalcoholic steatohepatitis ("NASH"), skin cancer and plaque psoriasis. After a temporary nosedive in 2016, share price appreciated by approximately 80% for the past 52-weeks. It is highly likely that recent capital appreciation is reflective of the firm's increasing intrinsic value due to key developments. A notable catalyst was the positive data for the exploratory phase 2a trial, which suggests that lead molecule GR-MD-02 could be used to treat plaque psoriasis. Despite the firm's emphasis on NASH, this research shall focus on the potential therapeutic application of GR-MD-02 for plaque psoriasis.

Source: Google Finance

Plaque Psoriasis

As an autoimmune disease, plaque psoriasis is caused by the body's natural defense system going haywire, thus, causing the presence of well-demarcated red silvery scales on the skin surface. Due to its chronic nature, patients are placed on lifelong therapy. According to expert recommendations, the treatment for plaque psoriasis depends on the disease's severity. Patients with mild to moderate disease are prescribed with topical corticosteroid as the first-line agent. For moderate to severe cases without any contraindication, phototherapy serves as the therapeutic of choice. Those who failed the mentioned light treatment are managed with various approved systemic drugs such as steroid and methotrexate.

Source: Visualdx

The main setbacks for systemic therapies relate to their adverse effects. Nonetheless, doctors still employ such treatments, because the benefits outweigh the risks. In contrast to currently available medicine, GR-MD-02 potentially has a favorable efficacy and safety profile. As a new medicine in its own class, Galectin's lead molecule has a favorable chance of cutting into the multibillion-dollar psoriasis market. This is due to the fact that physicians tend to prescribe a unique therapeutic, especially one with a favorable safety profile like GR-MD-02, rather than another medicine amongst many approved drugs. In other words, GR-MD-02 would have a better chance of market success than a statin in development.

Another positive note for investors is that global data projected sales for psoriasis to increase from $6.6B in 2014 to $13.3B by 2024. If Galectin can cut into a small portion of this pie, the share price should increase multiple folds. And this would signify warranted optimism for shareholders.

Serendipitous Finding

Originally employed in the phase 2 trial for NASH patients, GR-MD-02 was found by chance to be efficacious for treating plaque psoriasis, which often occurs along with NASH. One patient with mild psoriasis participating in the NASH trial reported complete skin disease resolution for over a year. Another patient with moderate psoriasis reported the lesser use of her usual steroid medication. As a result, the aforesaid serendipitous finding prompted Galectin to commence the exploratory phase 2a.

Exploratory Phase 2a Trial

In March 2017, Galectin reported promising data for psoriasis in the aforementioned open-label exploratory phase 2a trial. Five patients employed in the study were infused with 8 mg/kg of GR-MD-02, a total of 13 infusions, for 24 weeks. No serious adverse events were found. All patients achieved an average PASI ("Psoriasis Area and Severity Index") reduction of over 50%, which is a measure of symptomatic improvement. The promising exploratory trial data prompted further development of GR-MD-02 for psoriasis treatment. Nonetheless, Galectin remains focused on innovating therapeutics for NASH.

"We are pleased by the results of our 24-week psoriasis trial demonstrating the safety and efficacy of GR-MD-02 in patients with moderate to severe plaque psoriasis," said Peter Traber, M.D., president, chief executive officer ("CEO"), and chief medical officer ("CMO"). "Moreover, the activity of GR-MD-02 in a human disease strongly associated with non-alcoholic steatohepatitis and increased galectin-3 expression suggests that our lead compound may also show significant activity in NASH, which remains the company's primary target."

As Dr. Traber suggested, the positive psoriasis data can foretell favorable outcome for the NASH trials. In addition, we strongly believe that it is intelligent to speculate trials data results for both NASH and psoriasis by analyzing GR-MD-02's mechanism of action.

Unique Mechanism of Action

Galectins are small molecules in the body that direct communication within the cells when being bound to glycoproteins found on cellular surface. In the disease processes that include inflammation, fibrogenesis, cancer formation, galectin's activity is heightened. Numerous research reports found the supporting role of galectin in the development of psoriasis in human. And it is hypothesized that lead molecule GR-MD-02 works by inhibiting galectin, thus, halting the disease process while stimulating the body to heal itself.

Source: Galectin

Focusing on Orphan Disease

In building its presence in the multibillion-dollars orphan disease market, Galectin is conducting two clinical trials, NASH-CX and NASH-FX for the treatment of NASH cirrhosis and NASH advanced fibrosis, respectively. Investing in orphan disease is seemingly the new trend for biopharmaceuticals investing. A firm can charge a premium price for a drug that treats rare ("orphan") diseases. And not only that this is viewed favorably by authority, the approach also ensures profitability for the company as well as the availability of lifesaving drugs for patients.

Source: Galectin

NASH asides, Galectin concurrently innovates GR-MD-02 for treating other fibrotic conditions, including lung, kidney, and heart. In addition, the named molecule is being studied for its applications together with other approved therapies ("Yervoy and Keytruda") to treat the dreaded skin cancer that is melanoma.

Adequate Funding

The majority of developing biotech firms operate in the red, as it takes substantial capital in the ballpark of more than a billion dollars to fund a drug from bench research to marketing. Hence, one can observe the increasing trend in operational cash flow that is needed to develop GR-MD-02 in the figure below.

Source: Morningstar

It is wise for biotech investors to note three key financial metrics. The first is that dilutive financing is not excess. The second is that debt to equity is not staggering. The third is whether the firm has adequate capital to fund their drugs to full development. That being said, Galectin increased its shares outstanding from 6M to 30M for the past decade, which is not unwarranted for a developing biopharma. It is a good sign that the firm's balance sheet is clean of long-term debts while there is only $3.8M borrowed for the short-term. As of March 2017, $13M in non-restricted cash and cash equivalents remain for operational spending. This amount is adequate to fund operation through the end of this year, which is sufficient for the reporting of NASH-CX's top line data.

Capable Management

With the strong track record of performance and many years of wisdom, Peter Traber, M.D. is the top-notch CEO and CMO to navigate this ship for Galectin shareholders. Prior to joining Galectin, Dr. Traber served as CEO of the prestigious medical schools: Baylor University and the University of Pennsylvania. As the former CMO at GlaxoSmithKline (NYSE:GSK), Dr. Traber knows the ins of the large and successful biopharma.

Due to his uniquely diverse background as a physician, executive and a molecular biology research scientist with over 100 original research publications, Dr. Traber has the differentiated wisdom to gauge whether a molecule can succeed in both clinical trials as well as in the market. After all, a doctor knows which medicine will be likely prescribed. Burdening with a total of roughly $1B to be invested in a developing drug, it is comforting for investors that Dr. Traber is the cream of the crops expert. The chief is highly likely to deliver the best capital appreciation for shareholders and hopes for countless patients worldwide.

Potential Risks

As alluded, it takes significant funding to innovate a molecule from bench research to marketing. The chance of success is less than 5%, as more than 95% of the drugs in development failed to make it to the market. Therefore, it is imperative for investors to be cognizant that investing in a developmental stage biopharma incurs substantial risks as well as upsides. During this lengthy process, any negative data or indication of negativity can cause significant stock depreciation. An unfavorable trial outcome can nose dive share price by more than 50%. Conversely, positive data could throttle share price in the North by leaps and bounds. Substantial risks, volatility, and rewards are inherent to biotech investing. And while some investors lost money in biopharma investing, shareholders of Exelixis (NASDAQ:EXEL) and Jazz Pharmaceuticals (NASDAQ:JAZZ) have enjoyed over 10-bagger and 100-bagger returns, respectively.

To minimize the risks and to maximize the rewards, investors should exercise a basket approach to biopharma investing. A good strategy is to invest in a group of firms with promising drugs-in-development, leading by expert management with a strong track record, and having adequate cash to run their drugs through the complete innovation process. Of note, investors only need a few successful firms like Exelixis and Jazz to compound outstanding returns for a small portfolio in the run.

Conclusion

After the mini recession in the biopharmaceutical industry in late 2015 through 2016, there is a sense of warranted optimism in the market. Of many bio firms enjoying the late 2016 to 2017 rebound, Galectin has promising data and deserves the consideration of serious biotech investors. This small capitalization firm has a unique lead therapeutic that leverages on the biology of galectin to potentially treat the orphan disease, namely NASH. Moreover, the data favors its application to other conditions, particularly psoriasis, due to the drug's promising efficacy and safety profile. Despite that it is highly difficult to gauge the success of an early stage drug, the positive data for psoriasis can mean favorable outcome for the NASH trials. Furthermore, it only takes a single blockbuster, a drug that sells more than one billion dollars annually, to turn a small capitalization firm into a powerful growth biopharma. All in all, our analytical research reveals highly asymmetric risks to rewards that can deliver multiple folds capital appreciation for investors in the long run and hopes for patients worldwide.

Disclosure: I am/we are long GALT.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Editor's Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.

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Galectin Therapeutics: Serendipity In Psoriasis, Strength In NASH ... - Seeking Alpha

Posted in Psoriasis | Comments Off on Galectin Therapeutics: Serendipity In Psoriasis, Strength In NASH … – Seeking Alpha

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