Insmed has been 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 the Phase III results for the treatment of bronchiectasis.

The positive outcomes from the Phase III trial could pave the way for regulatory approval, potentially transforming the therapeutic landscape for bronchiectasis, a disease that currently lacks approval of any therapeutic treatment globally.

Other therapies are also being developed and are currently competing to demonstrate promising results from their Phase II trials, including Boehringer Ingelheim’s BI-1291583, Sanofi’s itepekimab, Chiesi’s CHF-6333, and Armata Pharmaceuticals’ APPA-02, as well as Renovion’s ascorbic acid.

The field may be considered attractive for pharmaceutical companies as there is a significant opportunity to acquire patient shares in a market that lacks approved therapies.

Brensocatib is an investigational anti-inflammatory molecule that inhibits the activity of neutrophil serine proteases (NSPs), as a dipeptidyl peptidase-1 reversible inhibitor, therefore suppressing neutrophils that contribute to the inflammatory environment present in non-cystic fibrosis bronchiectasis (NCFB) patients.

The previous Phase II study (WILLOW) demonstrated the efficacy of brensocatib in prolonging the time to first exacerbation and in reducing the frequency of exacerbations, through eliminating the numbers of multiple NSPs, including neutrophil elastase, proteinase 3, and cathepsin G, which have been previously implicated in the promotion of NCFB progression.

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As of now, Phase III clinical trials are ongoing for the assessment of brensocatib’s efficacy, safety, and tolerability in patients with bronchiectasis, which were expected to have been completed by the first quarter of 2024, the results of which are highly anticipated by the medical community.

The outcomes 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 leading data and analytics company GlobalData’s Sales and Forecast Database, brensocatib’s sales are anticipated to reach $1.2bn by 2030, subject to approval.

In addition to bronchiectasis, brensocatib is also in Phase II clinical trials for cystic fibrosis and chronic rhinosinusitis without nasal polyps, highlighting possible opportunities for Insmed to expand the agent’s label into these indications.

As expected, the competition in the bronchiectasis treatment landscape has increased over the years, with multiple pharmaceutical companies entering the race to obtain approval for their respective pipeline agents.

As the treatment landscape for bronchiectasis is currently governed by off-label therapies, there is an urgent need in the field for the development of advanced therapies that can target the disease at a cellular level, highlighting an opportunity for pharmaceutical companies to enter a market with potential for rapid expansion within the bronchiectasis field.