Insmed's lung disease drug succeeds in late-stage study

(Reuters) -Insmed said its drug candidate for a chronic lung disease helped significantly reduce the frequency of respiratory symptoms such as chronic cough in a late-stage study, prompting its shares to double in premarket trading on Tuesday.

Data from 1,680 adult and 41 adolescent patients with non-cystic fibrosis bronchiectasis also showed the drug, brensocatib, was safe and well-tolerated at the two tested dosages, 10 milligrams and 25 milligrams.

Bronchiectasis is a chronic disease in which the airways in the lungs become permanently dilated due to chronic inflammation and infection, causing symptoms including excessive sputum production, shortness of breath, and repeated respiratory infections.

It affects 350,000 to 500,000 adults in the United States, according to the American Lung Association, and has no approved treatments currently.

"Given the unmet need and lack of treatment options for patients with bronchiectasis, we expect rapid uptake for brensocatib once it is approved," Guggenheim analyst Vamil Divan wrote in a note.

The company said it plans to file a marketing application for brensocatib with the U.S. Food and Drug Administration in the fourth quarter of this year, and it expects to launch the drug in mid-2025.

It also plans to launch the drug in Europe and Japan in the first half of 2026.

Evercore ISI analyst Liisa Bayko estimates peak sales of $4.5 billion from the drug in the United States, the European Union and Japan by 2033.

Insmed's brensocatib belongs to a class of drugs that work by inhibiting an enzyme responsible for activating certain inflammation-causing compounds released by immune cells.

(Reporting by Mariam Sunny in Bengaluru; Editing by Krishna Chandra Eluri and Shinjini Ganguli)