Anticipation builds as Insmed bronchiectasis therapy brensocatib nears Phase III completion: GlobalData

Insmed is in the spotlight over the past few years for its pipeline agent, brensocatib, which has previously shown promising Phase II results, generating anticipation within the medical community ahead of their Phase III results for the treatment of bronchiectasis. The positive outcomes could pave the way for regulatory approval, potentially transforming the therapeutic landscape for bronchiectasis, a disease that lacks the approval of any therapeutic treatment globally as of now. With other pharmaceutical companies entering the race for developing the first marketed therapy against bronchiectasis, the great opportunity in the market is underlined, says GlobalData, a data and analytics company.

Brensocatib is a dipeptidyl peptidase-1 (DPP-1) reversible inhibitor which exhibits anti-inflammatory action through suppressing the activity of neutrophil serine proteases (NSP), thus inhibiting neutrophils that contribute to the inflammatory environment present in non-cystic fibrosis bronchiectasis (NCFB) patients. With Phase IIb study (WILLOW) demonstrating the efficacy of brensocatib in prolonging the time to first exacerbation and in reducing the frequency of exacerbations, the wider medical community is anticipating the ongoing Phase III clinical trial results for brensocatib’s efficacy, safety and tolerability in patients with NCFB.

Filippos Maniatis, Healthcare Analyst at GlobalData, comments: “Brensocatib Phase III results have been anticipated for quite a while now, with key opinion leaders expressing their excitement about the previous clinical trial results (WILLOW) for NCFB patients, and its potential approval. However, the outcomes of the anticipated Phase III study (ASPEN) will determine the future of brensocatib in the treatment landscape of bronchiectasis, as the presence of promising findings will progress the agent closer to market authorisation.”

According to GlobalData’s Sales and Forecast database, brensocatib’s sales are anticipated to reach $1.2 billion by 2030, subject to approval, and the competition in the bronchiectasis treatment landscape is expected to increase over the next few years. Agents such as Boehringer Ingelheim’s cathepsin C inhibitor BI-1291583, Regeneron’s anti-IL-33 monoclonal antibody itepekimab, Chiesi’s human neutrophil elastase inhibitor CHF-6333, Armata Pharmaceuticals’s APPA-02 as well as Renovion’s ascorbic acid, are in Phase II clinical trials and are currently competing for future market authorisation.

Overall, the bronchiectasis landscape has seen significant growth over the years, with the competition increasing as companies get closer to market authorisation. Nevertheless, the lack of advanced therapies for bronchiectasis intensifies the attention of the wider medical community and increases the anticipation for further results on pipeline agent studies.

Maniatis concludes: “The projected sales of brensocatib may further reflect the great significance and impact of its potential approval on the bronchiectasis market, as it will be the first-to-market therapy for the treatment of bronchiectasis. As the treatment landscape is currently governed by off-label therapies, the unmet need in the field related to the development of advanced therapies that can target the disease at a cellular level is uncovered can be seen as an opportunity for pharmaceutical companies to enter a market with potentials of rapid expansion within this indication.”

Edits made by EP News Bureau