South Korea-based clinical-stage biotech company Bridge Biotherapeutics (KQ288330) announced on Monday that it has completed enrolment in the phase two clinical study of BBT-877, a novel autotoxin (ATX) inhibitor, intended for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic lung disease.
The Phase two study is a multi-centre, randomised, double-blind, placebo-controlled study (NCT05483907) that is aimed at assessing the efficacy, safety, and tolerability of BBT-877 in patients with IPF, with or without anti-fibrotic (AF) approved background therapies (pirfenidone or nintedanib).
The study's primary objective is the assessment of the efficacy of BBT-877 in IPF patients by measuring the decrease in forced vital capacity (FVC) in subjects treated with BBT-877 compared to those treated with a placebo at week 24 of treatment. The study's secondary objectives include the assessment of drug safety, pharmacokinetics (PK), diffusing capacity of lung for carbon monoxide (DLCO), and functional exercise capacity in all patients.
The study enrolled a total of 120 participants from around 50 clinical trial sites located in the US, South Korea, Australia, Poland, and Israel. Patients were randomised to either the experimental drug arm or the placebo arm, following a 200mg, twice daily (BID) regimen of BBT-877 or a placebo. The firm expects topline data from the study to be revealed in the first half of 2025.
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