2020-02-03| R&DTrials & Approvals

Insmed Soaring High with Positive Phase II Results for Non Cystic Fibrosis Bronchiectasis Drug, INS1007

by Ruchi Jhonsa
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By Ruchi Jhonsa, Ph.D.

Insmed Incorporated, a New Jersey based biopharmaceutical company, today reported positive Phase II results for INS1007, a potential drug for treating non-cystic fibrosis bronchiectasis (NCFBE). The company’s stocks skyrocketed 36% upon release of the news.

What is NCFBE?

NCFBE is a chronic lung disorder in which the bronchi becomes inflamed, damaged and permanently dilated due to a cycle of infection and inflammation. The condition is marked by pulmonary exacerbations that include frequent coughing, sputum production, shortness of breath and acute decrease in lung function. Patients with NCFBE require frequent antibiotic therapy or hospitalizations, which worsens the underlying condition. Approximately, 3,40,000 to 5,20,000 patients are affected currently in the US alone with no approved treatment.

What Does INS1007 Do?

INS1007 is an investigational, first-in-class, selective, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) enzyme. DPP1 is responsible for activating neutrophil serine proteases (NSPs) such as neutrophil elastase inside the neutrophils, while they are forming inside the bone marrow. Neutrophils are a type of white blood cells that play an essential role in the neutralization of pathogens by releasing inflammatory cytokines. In conditions like chronic inflammatory lung diseases, neutrophils accumulate in the airways and cause excessive activation of NSPs that cause lung destruction and inflammation. By decreasing the activation of NSPs, thereby damaging action of Neutrophils, INS1007 may decrease lung damage in NCFBE patients.

The Phase II Study

INS1007 was evaluated in a global, randomized, double-blind placebo-controlled Phase II, WILLOW study that measured the efficacy, safety, and pharmacokinetics of the drug. The study was conducted at 116 sites and included 256 adults diagnosed with NCFBE who had at least two documented pulmonary exacerbations in 12 months before screening. Patients were divided in a ratio of 1:1:1 and injected with either 10mg or 25mg of the drug or matching placebo once daily for 24 weeks. The primary efficacy endpoint tested was the time to first pulmonary exacerbation over the 24-week treatment period in the drug group compared to the placebo group.

The study showed that the drug met its primary efficacy endpoint of time to first pulmonary exacerbation. Moreover, the drug reduced frequency of pulmonary exacerbations in comparison to the placebo, which was a crucial secondary endpoint. To be specific, a 36% and 25% reduction was seen in the pulmonary exacerbations in the 10mg and 25mg arm respectively in comparison to the placebo group. Additionally, change in the concentration of active elastase in sputum in comparison to placebo from baseline to the end of the treatment period was also statistically significant (p=0.034 for 10mg, p=0.021 for 25mg).

Adverse effects were seen in both drug treated and placebo patients. The most common adverse events in the drug arm included cough, headache, increase in sputum, fatigue and upper respiratory tract infections. Over 24 weeks, rates of adverse events leading to discontinuation in patients were 10.6%, 7.4% and 6.7%, respectively.

Views On the Future of INS1007

“This molecule represents a novel, potentially first in class mechanism that utilizes an anti-inflammatory approach to treat the debilitating cycle of inflammation, infection, and lung damage associated with NCFBE,” said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. “The data provide a strong rationale for continued development in this disease and potentially other neutrophil-driven inflammatory conditions”.

The lead investigator of the study Prof. James Chalmers from the University of Dundee, UK also explained the unmet need in this area. “Today, many bronchiectasis patients suffer from persistent symptoms and frequent exacerbations, with no pharmaceutical therapies available that are approved to help them manage the disease. There is an urgent need for approved, effective therapies that can break the vicious cycle of inflammation, lung damage, and infection for these patients.”




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