FDA starts review of first bronchiectasis drug candidate
Insmed's chief medical officer Martina Flammer.
The FDA has started a priority review of Insmed's brensocatib, which is pitching to become the first approved therapy for chronic lung disease bronchiectasis in the US.
The regulator has set a timeframe of 12th August for its review of the new drug application (NDA) and – if approved – brensocatib could become a much-needed treatment option for hundreds of thousands of patients.
In bronchiectasis, the walls of the airways become thickened and damaged as a result of a cycle of inflammation and infections. It is characterised by repeated exacerbations or attacks, which require treatment with antibiotics and sometimes result in patients being hospitalised. The disease is thought to be associated with incorrect functioning of neutrophils, a form of white blood cell.
It can be precipitated by childhood lung infections like severe pneumonia, whooping cough, and measles, immunodeficiency disorders, cystic fibrosis, and some inflammatory diseases like rheumatoid arthritis. However, in many cases, the cause remains unknown.
DPP1 inhibitor brensocatib has been submitted for approval by the FDA for non-cystic fibrosis bronchiectasis based on the results of the ASPEN trial, which showed that the drug cut the number of attacks experienced in a year by around 20% compared to placebo, whilst also prolonging the time to a first exacerbation and increasing the chances of patients becoming exacerbation-free over 52 weeks of follow-up.
Side effects were fairly minor and included nasopharyngitis, cough, and headache, according to the data.
It's not clear yet whether the FDA will convene an advisory committee meeting to review the data on brensocatib, which according to Insmed is the drug in the DPP1 inhibitor class to be reviewed for the treatment of neutrophil-mediated diseases.
Shares in Insmed have almost tripled over the past year on the promise of brensocatib, which some analysts have predicted could be on course for multibillion-dollar revenues, and led to speculation that the company could become a takeover target – although its current valuation of almost $14.5 billion could make it an expensive wager.
"Brensocatib has the potential to transform the treatment landscape for bronchiectasis and we were pleased to receive the FDA acceptance of our NDA with priority review even earlier than anticipated," commented Insmed's chief medical officer, Martina Flammer.
The company also intends to file brensocatib in the EU, Japan, and the UK before the end of the year. Meanwhile, it is also running phase 2 trials of the DPP1 inhibitor in chronic rhinosinusitis without nasal polyps (CRSsNP) and hidradenitis suppurativa (HS).
Other drugs in development for bronchiectasis include Armata Pharma’s AP-PA02 – a bacteriophage-based therapy for non-CF bronchiectasis caused by chronic Pseudomonas aeruginosa infections, which recently generated positive phase 2 data in the Tailwind study – along with Boehringer Ingelheim's cathepsin C Inhibitor BI-1291583 (phase 2), Sanofi's anti-IL-33 antibody itepekimab (phase 2), and Chiesi's human neutrophil elastase inhibitor CHF-633 (phase 1/2).
