DetailsCategory: Small MoleculesPublished on Thursday, 23 April 2020 17:59Hits: 835

--Insmed to support STOP-COVID19 Study, Expected to Begin in the UK in May 2020--

BRIDGEWATER, NJ, USA I April 23, 2020 I Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that it will provide funding and clinical drug supply for the STOP-COVID19 (Superiority Trial of Protease inhibition in COVID-19) trial, an investigator-initiated study of brensocatib (formerly known as INS1007) in up to 300 hospitalized patients with COVID-19 sponsored by the University of Dundee. The study, which has been prioritized and designated an Urgent Public Health trial by the UK's National Institute for Health Research, is expected to begin enrollment in May 2020.

Brensocatib is a novel oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) currently being developed by Insmed for the treatment of bronchiectasis and other inflammatory diseases. DPP1 is an enzyme that catalyzes the activation of neutrophil serine proteases (NSPs) in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. By inhibiting the activation of NSPs, brensocatib may offer applicability in a range of neutrophil-mediated diseases. Neutrophil influx into the lungs is a defining characteristic of acute respiratory distress syndrome (ARDS), a severe outcome of COVID-19 that is associated with high mortality. Reduction of neutrophil proteases may reduce the progression of lung injury and the need for ventilation in these patients.

"The global COVID-19 pandemic has generated an extraordinary response from the biopharmaceutical industry to bring to bear all potential means of fighting this disease and preventing its most severe outcomes, including the need for ventilation and ICU stays," said Martina Flammer, M.D., Chief Medical Officer of Insmed. "At the start of the outbreak, Insmed began pursuing an in vivo mouse model to better understand the potential of brensocatib in preventing ARDS. As we rapidly advance this early-stage research simultaneously, we are very pleased to support Professor James Chalmers and the University of Dundee in leading a controlled clinical trial that will help us evaluate the potential impact of brensocatib on hospitalized patients suffering from severe COVID-19."

The STOP-COVID19 trial is a prospective, randomized, double-blind, placebo-controlled trial of brensocatib in patients with severe COVID-19. The multicenter study is expected to enroll up to 300 patients at 10 sites in the UK who present to the hospital with confirmed COVID-19 and are at risk of needing increased levels of supplemental oxygen and/or ventilation. Patients will be randomized 1:1 to receive either brensocatib 25 mg once daily or matching placebo on top of standard of care. The primary endpoint is clinical improvement on a seven-point ordinal scale as defined by the World Health Organization. Patients will be treated for 28 days, with a sample-size reassessment performed once 100 patients have been enrolled and treated.

"The medical community has never faced a more urgent need for treatment than the unprecedented situation we face today with COVID-19," said lead study investigator James Chalmers, MBChB, Ph.D., Professor and Consultant Respiratory Physician at the School of Medicine,University of Dundee, UK. "The mechanism of action of brensocatib that we observed in a Phase 2 study in patients with non-cystic fibrosis bronchiectasis provides a strong rationale for evaluating this novel treatment candidate in other neutrophil-driven inflammatory conditions. It is my hope that this novel approach will have applicability in patients at risk of ARDSa devastating outcome of COVID-19 for which there are currently no approved therapies."

In February 2020, Insmed reported positive top-line results from the global randomized, double-blind placebo-controlled Phase 2 WILLOW study evaluating the efficacy, safety, and pharmacokineticsof brensocatib in adults with non-cystic fibrosis bronchiectasis. In this study of more than 250 patients, brensocatib was generally well-tolerated. The study met both its primary and key secondary endpoint.

Insmed will continue to develop brensocatib in patients with bronchiectasis and expects to begin enrollment in a Phase 3 programin the second halfof 2020 following anticipated discussions later this year with health authorities on the design of the program.

About Brensocatib (Formerly INS1007)

Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase I (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs.

About Insmed

Insmed Incorporated is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. Insmed's first commercial product, ARIKAYCE (amikacin liposome inhalation suspension), is the first and only therapy approved inthe United Statesfor the treatment of refractoryMycobacterium aviumcomplex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. MAC lung disease is a chronic, debilitating condition that can cause severe and permanent lung damage. Insmed's earlier-stage clinical pipeline includes brensocatib, a novel oral reversible inhibitor of dipeptidyl peptidase 1 with therapeutic potential in non-cystic fibrosis bronchiectasis and other inflammatory diseases, and INS1009, an inhaled formulation of a treprostinil prodrug that may offer a differentiated product profile for rare pulmonary disorders, including pulmonary arterial hypertension. For more information, visitwww.insmed.com.

SOURCE: Insmed

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