Investors in Insmed (NASDAQ: INSM) are having an incredible start to the short trading week. Shares of the rare disease focused biotech are up 110% as of 11:15 a.m. EDT, after the company announced upbeat top-line results from its phase 3 Convert trial.
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The Convert trial was designed to measure the effect of adding Insmed's drug Amikacin Liposome Inhalation Suspension (ALIS) to guideline-based therapy (GBT) in patients who have treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by mycobacterium avium complex.
Data from the 336-patient trial showed that ALIS was able to meet its primary endpoint. Specifically, the study showed that adding ALIS to guideline-based therapy eliminated evidence of NTM lung disease by month 6 in 29% of patients. That was a statistically significant increase when compared to the 9% of patients who received GBT alone.
This data was so encouraging that Insmed plans on pursuing accelerated approval for ALIS. The therapy has also already been granted both "breakthrough therapy" designation and fast-track status by the U.S. Food and Drug Administration.
Insmed's CEO Will Lewis stated:
Given the upbeat clinical news, it is easy to understand why investors are cheering today.
The only potential wrinkle in the data related to the drug's safety. The dropout rate for patients who used ALIS and GBT was 19.6%, which was a fair bit higher than the 9% dropout rate observed in the GBT group alone. Management stated that safety issues "were predominately mild or moderate in nature and generally declined after the second month of treatment."
To give investors more context on this issue, Dr. Paul Streck, Insmed's chief medical officer, offered this commentary:
All in all, today's clinical update clearly provides investors with reasons to be bullish on the future of Insmed. Risk-loving investors might want to consider putting this small-cap biotech on their watchlist.
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