US-based Insmed has shared more data from the Phase III ASPEN trial, showing that brensocatib also reduced the decline in lung function in bronchiectasis patients.
The forced expiratory volume (FEV1) data from the study (NCT04594369) shows a statistically significant reduction in the decline of lung function in the high-dose brensocatib arm compared to placebo.
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Insmed has announced the additional positive results from the global study which is assessing the efficacy, safety, and tolerability of the therapy in patients with non-cystic fibrosis bronchiectasis.
The company announced that the ASPEN study met its primary endpoint of reduction in the annualised rate of pulmonary exacerbations (PEs) in both the low and high-dose arms on 28 May 2024.
Lead investigator and consultant respiratory physician at the School of Medicine, University of Dundee, Dr James Chalmers said: “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. This data further underscores the positive impact that brensocatib may have on patients if approved.”
The new data will be presented in full on July 4, 2024, at the 7th World Bronchiectasis Conference (WBC) in Dundee, Scotland.
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By GlobalDataThis data, set to be presented at WBC, will also evaluate endpoints of post-bronchodilator forced vital capacity (FVC) at week 52, a measure of lung function and another exploratory endpoint from the trial.
Patients treated with high dose brensocatib showed nominally significantly less decline in FVC compared to placebo.
Insmed CMO Martina Flammer, said: “The additional data to be presented include exploratory endpoints that further support our belief that brensocatib may have a transformational impact on the management of bronchiectasis. The efficacy demonstrated in ASPEN, combined with a favourable safety profile that was comparable to placebo, underscore the potential for brensocatib to be used as a chronic treatment for patients with bronchiectasis, pending approval.”
Insmed plans to file a new drug application to the US Food and Drug Administration in patients with bronchiectasis in Q4 2024 with an anticipated launch in mid-2025.
Brensocatib acts by targeting cathepsin C, also known as dipeptidyl peptidase 1 (DPP1). DPP1 is a lysosomal exo-cysteine protease belonging to the peptidase C1 protein family.
GlobalData predicts global sales of brensocatib to reach $1.28bn in 2030.
GlobalData is the parent company of the Clinical Trials Arena.
