What happened
Shares of Insmed(NASDAQ: INSM) were soaring 17.1% higher as of 11:27 a.m. ET on Tuesday. The big gain came after the company announced positive top-line results from its late-stage Arise clinical study evaluating the antibiotic drug Arikayce in treating patients with newly diagnosed or recurrent nontuberculous mycobacterial (NTM) lung infection caused by Mycobacterium avium complex (MAC) who had not yet been treated with antibiotics. MAC lung disease is rare but can cause severe lung damage and can be fatal.
Today's jump continued a steady rise for the biotech stock in recent months. Insmed's share price is now up more than 30% year to date.
So what
Arikayce has already received accelerated approval from the U.S. Food and Drug Administration (FDA) for treating MAC lung disease. But that approval is for Arikayce in combination with other antibacterial drugs and only for adults with limited or no alternative treatment options. Insmed hopes to move beyond such a limited approval.
The latest results improve the company's chances of fulfilling those hopes. Importantly, the Arise study showed that the Quality of Life-Bronchiectasis (QOL-B) instrument was effective as a patient-reported outcome tool for patients with MAC lung disease. There currently aren't any established clinical endpoints to evaluate treatments for the disease.
This is important because Insmed is also conducting its Encore late-stage study of Arikayce in patients with newly diagnosed or recurrent MAC lung disease who haven't started antibiotics. Based on the Arise study results, the company thinks that QOL-B is an appropriate tool to measure improvement in the Encore study.
Now what
Insmed now has to convince the FDA that QOL-B can be used in the Encore study without any modifications. The Arise data should help tremendously in making that argument.
The company also plans to explore the possibility of an accelerated approval filing based on the Arise data. That could be a more difficult task, though, considering that the study wasn't powered to identify statistically significant differences between treatment arms.
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