Insmed soars on strong results for inhaled antibiotic
- Insmed Inc. saw its share spike 115% to trade above $26 per share on Tuesday after the biotech announced positive topline results for its inhaled antibiotic.
- The Phase 3 CONVERT study was able to show the drug met it primary endpoint of culture conversion for patients with the rare lung disease with both clinical and statistical significance.
- The Bridgewater, NJ-based biotech intends to pursue accelerated approval of ALIS (Amikacin Liposome Inhalation Suspension) in patients with treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by mycobacterium avium complex (MAC).
Insmed shares rocketed up on Tuesday's results, which the company said support a quick filing for approval with the Food and Drug Administration. The drug already has qualified infectious disease product (QIDP) status and a fast track designation.
The CONVERT study showed ALIS was able to eliminate evidence of the rare lung disease in 29% of patients when added to guideline-based therapy, compared to 9% of patients on guideline-based therapy alone. The results were determined by culture conversion over a six month time period.
Additionally, those given ALIS as well as guideline-based therapy were able to show culture conversion 30% faster than those on the guideline-based therapy alone.
Treatment with ALIS didn't result in a statistically significant improvement on a secondary endpoint of a six-minute walk test, although the company did note that those patients (on either regimen) who did achieve culture conversion showed an improvement on this measure. While this adds a layer of confusion to the data, the company thinks the primary endpoint efficacy is strong enough to gain FDA approval.
There are currently no approved treatments for this rare lung disease, but the guideline-based therapy is considered the best available option.
"This represents the first ever global Phase 3 controlled study in patients with NTM, a rare, progressive and destructive infection that is associated with irreversible lung damage and increased rates of mortality," said Paul Streck, chief medical officer of Insmed. "Our drug candidate, ALIS, delivers high levels of an aminoglycoside directly to the lung macrophages and pulmonary tissue where the infection resides, and we believe this accounts for the significant impact on conversion that the drug demonstrated in these trial results."
- Insmed Press release
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