) shares skid over 13% after the company announced that its
candidate, Arikayce, failed to meet the primary objective in a
phase II study (n=90). The candidate is being developed for the
treatment of patients suffering from treatment resistant
nontuberculous mycobacterial (NTM) lung infections.
The primary objective of the phase II study was a
semi-quantitative measurement of the difference in mycobacterial
density on a seven-point scale from baseline to the end of the
randomized portion of the study. However, the candidate failed to
meet the pre-specified level for statistical significance.
The phase II study evaluated Arikayce plus standard of care
treatment against standard of care treatment plus placebo in
treatment resistant NTM lung infected adults. These patients were
on American Thoracic Society/Infectious Disease Society of
America (ATS/IDSA) guideline therapy for a minimum period of six
months before screening. These patients also continued to have
positive mycobacterial cultures.
Insmed plans to discuss the results with the U.S. and EU
regulatory authorities to decide the future path for Arikayce.
Arikayce enjoys orphan drug designation for the NTM indication
both in the U.S. and the EU. The company mentioned in its press
release that currently there are no approved drugs in the U.S.
for the treatment of this chronic, debilitating disease.
The results from the study are disappointing. Insmed is primarily
focused on the development of Arikayce. Successful development of
the candidate is important for the company's growth. Similar
setbacks may pull down the stock further.
Insmed is also developing Arikayce for the treatment of
pseudomonas aeruginosa (Pa) in patients suffering from cystic
fibrosis (CF). The candidate is currently in an ongoing two-year,
open-label extension study for this indication. Arikayce also
enjoys orphan drug designation for the CF indication both in the
U.S. and EU. We expect investor focus to stay on Arikayce going
Insmed, a biopharmaceutical company, currently carries a Zacks
Rank #3 (Hold). Some better ranked stocks in the same sector
Gilead Sciences Inc.
Alexion Pharmaceuticals, Inc
). All stocks carry a Zacks Rank #1 (Strong Buy).
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