Insmed shares double on positive lung drug data

New Jersey-based pharmaceutical company Insmed saw a significant increase in its market value, rising by over $3 billion, following the announcement of promising clinical trial results for its novel lung disease medication. The drug, brensocatib, demonstrated its efficacy in treating bronchiectasis, a condition characterized by the dilation, infection, and inflammation of the bronchi in the lungs. The results of the Phase 3 clinical trial, known as Aspen, were particularly encouraging, showing that brensocatib could notably reduce symptoms like coughing and shortness of breath.

The Aspen trial revealed that brensocatib reduced the annual rate of pulmonary exacerbations by approximately 20% compared to a placebo. This reduction also allowed patients to go longer periods without experiencing these exacerbations. Importantly, the side effects of brensocatib were found to be on par with those of the placebo, with similar rates of common adverse events such as colds, coughs, and headaches, as well as more serious issues like infections and pneumonia.

Insmed is preparing to submit an application for brensocatib's approval to the Food and Drug Administration (FDA) by the end of the year, aiming to launch the drug in the United States by mid-2025. The company also plans to seek regulatory approval in Europe and Japan. Bronchiectasis, which can be caused by cystic fibrosis, affects roughly 450,000 individuals in the U.S. who do not have cystic fibrosis, as well as another 550,000 people in Europe and Japan. Unlike cystic fibrosis, which has several effective treatments, there are no approved therapies for bronchiectasis not linked to cystic fibrosis in these regions.

The clinical trial involved about 1,700 participants from 35 countries, who were randomly assigned to receive either one of two doses of brensocatib or a placebo daily for a year. The results showed that a 10 milligram dose of brensocatib reduced the annual rate of pulmonary exacerbations by 21.1% compared to the placebo, while a 25 milligram dose resulted in a 19.4% reduction. Both doses achieved statistically significant results.

While the secondary endpoints of the study showed mixed results, both doses of brensocatib were effective in significantly prolonging the time to the first pulmonary exacerbation and increasing the likelihood of participants remaining exacerbation-free over the course of the 52-week study.

Analysts lauded the study’s success as a significant boost for Insmed. Graig Suvannavejh from Mizuho Securities noted that the positive outcome would likely foster a more favorable outlook for the company’s future. Stephen Willey from Stifel suggested that the robust data could position Insmed as a notable biotech firm on a path to achieving over $5 billion in peak annual revenues. Joseph Schwartz from Leerink Partners echoed this sentiment, comparing brensocatib’s potential market impact to that of other highly successful drugs like Dupixent and Humira.

Insmed is also exploring the potential of brensocatib in treating other inflammatory conditions driven by neutrophils, such as chronic rhinosinusitis without nasal polyps and hidradenitis suppurativa. Following the announcement, Insmed’s shares surged by more than 112%, reaching approximately $47 per share.