Shares of Insmed $INSM more than doubled Tuesday morning after the company released Phase 3 data in a respiratory disease called bronchiectasis.
The company’s drug, known as brensocatib, reduced patients’ pulmonary exacerbations by about 20% in both the low- and high-dose arms compared to placebo, Insmed said Tuesday. The biotech expects to file for FDA approval by the end of 2024, with a potential decision expected in “mid-2025,” according to a press release.
Will Lewis“These results make the pathway to approval non-controversial, in our view,” CEO Will Lewis said on Tuesday morning’s investor call.
In the trial, researchers examined a 10 mg and 25 mg dose of brensocatib and followed patients for one year. The 10 mg dose group reported a 21.1% reduction in pulmonary exacerbations, while the 25 mg dose group saw a 19.4% reduction. Both p-values — p=0.0019 and p=0.0046, respectively — were statistically significant.
The data surpassed analysts’ expectations for a bull case. Mizuho’s Graig Suvannavejh wrote in a Monday evening note to investors that a p-value lower than p<0.01 in either dose arm would likely be enough to secure an FDA approval. Suvannavejh estimates peak sales at $1 billion in non-cystic fibrosis bronchiectasis.
Insmed’s company focus now moves toward execution, Lewis said on the investor call. He said the Phase 3 data have validated the drug’s mechanism — if approved, it would be the first dipeptidyl peptidase 1 (DPP1) inhibitor on the market.
The data could also read through to other immunological conditions like hidradenitis suppurativa and chronic rhinosinusitis without nasal polyps, lead investigator James Chalmers said on the call. Tuesday’s results “really makes this a potential breakthrough, not just in bronchiectasis, but in treating neutrophil-driven disorders more broadly,” Chalmers said.
The Phase 3 study comes after Insmed previously won a 2018 approval for Arikayce in lung disease caused by the bacteria group Mycobacterium avium complex. An FDA green light for brensocatib would be the company’s second approved product, and the first in bronchiectasis, with Chalmers saying he expects “swift adoption.”
Lewis added that Insmed is still figuring out how much the drug might cost, teasing a commercial presentation in early June.