Insmed Incorporated
INSM
announced that it has dosed the first patient in the phase III ASPEN study, which evaluated its novel, oral, first-in-class pipeline candidate brensocatib for treating patients with bronchiectasis– a severe chronic pulmonary disorder.
The double-blind, placebo-controlled ASPEN study will evaluate the safety, efficacy and tolerability of brensocatib for the given indication. The primary endpoint of the study will check the rate of pulmonary exacerbations over the 52-week treatment period. The company plans to enroll approximately 1,620 patients in the above-mentioned study. Notably, patients with bronchiectasis caused due to cystic fibrosis might not be enrolled in the study.
Shares of Insmed were up 1.6% following the announcement of the news on Wednesday. In fact, the stock has rallied 66.5% so far this year compared to the
industry
’s increase of 3.8%.
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Brensocatib, a reversible inhibitor of dipeptidyl peptidase 1, is being developed for the treatment of patients with bronchiectasis and other inflammatory diseases.
Per the company, data from the phase II WILLOW study showed that treatment with brensocatib prolonged the time to first exacerbation as well as reduced the risk of exacerbation over a 24-week treatment period. Based on the strong result from the WILLOW study, the company initiated the registrational ASPEN study.
We note that the FDA has granted a Breakthrough Therapy Designation to brensocatib for addressing patients with bronchiectasis.
In November 2020, the European Medicines agency also granted a Priority Medicines (PRIME) tag to brensocatib for the treatment of non-cystic fibrosis bronchiectasis (“NCFBE”). The prestigious tag was based on positive data from the phase II WILLOW study which evaluated brensocatib in adults with NCFBE.
Zacks Rank & Stocks to Consider
Insmed currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include
Catalyst Biosciences, Inc.
CBIO
,
Halozyme Therapeutics, Inc.
HALO
and
Aptose Biosciences, Inc.
APTO
, all carrying a Zacks Rank #2 (Buy) at present. You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Catalyst Biosciences’ loss per share estimates have narrowed 13.2% for 2020 and 7.7% for 2021 over the past 60 days.
Halozyme’s earnings estimates have been revised 29.5% upward for 2020 and 19.4% for 2021 over the past 60 days. The stock has skyrocketed 129.3% year to date.
Aptose Biosciences’ loss per share estimates have narrowed 10.3% for 2020 and 4.7% for 2021 over the past 60 days. The stock has rallied 19.2% year to date.
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