Insmed - Additional Positive Data from Pivotal ASPEN Study of Brensocatib in Patients with Bronchiectasis to be presented at the 7th World Bronchiectasis Conference
July 04, 2024 at 02:58 pm
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BRIDGEWATER - Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that additional positive results from the ASPEN study, a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis, will be presented tomorrow, July 4, 2024, at the 7th World Bronchiectasis Conference (WBC) in Dundee, Scotland.
Slides from this presentation can be found here.
As previously announced, the ASPEN study met its primary endpoint, with both dosage strengths of brensocatib achieving statistical and clinical significance for the reduction in the annualized rate of pulmonary exacerbations (PEs) versus placebo over the 52-week treatment period. The annualized rate of exacerbations was 1.015 for the brensocatib 10 mg group, 1.036 for the brensocatib 25 mg group, and 1.286 for placebo, representing a 21.1% risk reduction from placebo for the brensocatib 10 mg group (p=0.0019) and a 19.4% risk reduction for the 25 mg group (p=0.0046). Both dosage strengths of brensocatib also met several secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the odds of remaining exacerbation-free over the treatment period.
'The ASPEN findings are critically important given that there is no approved treatment for bronchiectasis and there remains an urgent need for a therapy that can both reduce pulmonary exacerbations and lessen the burden of this disease. The data announced today further underscore the positive impact brensocatib may have on patients if approved,' said lead study investigator James Chalmers, MBChB, Ph.D., Professor and Consultant Respiratory Physician at the School of Medicine, University of Dundee, UK. 'Bronchiectasis is a progressive disease that causes patients to lose lung function over time. Therefore, I am particularly encouraged by the data which showed that the 25 mg dose of brensocatib may slow the rate of decline of FEV1 and FVC, which represent clinically meaningful parameters of lung function that physicians consider important outcome measures.'
The study assessed change in lung function, as measured by change from baseline in post-bronchodilator forced expiratory volume over one second (FEV1) at Week 52, a key secondary endpoint. Patients treated with brensocatib 25 mg demonstrated significantly less FEV1 decline, preserving more lung function as compared to placebo (LS mean change of 38 mL, p=0.0054). Patients in the placebo arm lost on average 62 mL of FEV1 in one year. In addition, new data will be presented at WBC measuring the change from baseline in post-bronchodilator forced vital capacity (FVC) at Week 52, another measure of lung function and an exploratory endpoint in the study. Patients treated with brensocatib 25 mg showed nominally significantly less decline in FVC compared to placebo (LS mean change of 75 mL, p
Insmed Incorporated is a global biopharmaceutical company. The Company's first commercial product, ARIKAYCE (amikacin liposome inhalation suspension), is used for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. Its pipeline includes clinical-stage programs, brensocatib and TPIP, as well as other early-stage research programs. Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), which is developing for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases, including chronic rhinosinusitis without nasal polyps (CRSsNP). TPIP is an inhaled formulation of the treprostinil prodrug treprostinil palmitil, which offers a differentiated product profile for pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH).
Insmed - Additional Positive Data from Pivotal ASPEN Study of Brensocatib in Patients with Bronchiectasis to be presented at the 7th World Bronchiectasis Conference