South Korea-based biotechnology company Bridge Biotherapeutics has finished enrolling subjects in a Phase II clinical trial of BBT-877, a new autotoxin inhibitor designed to treat idiopathic pulmonary fibrosis (IPF).
The trial enrolled 120 subjects across nearly 50 clinical trial sites in the US, South Korea, Poland, Australia and Israel.
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The double-blind, placebo-controlled study aims to assess BBT-877’s efficacy, safety and tolerability in IPF patients with and without currently approved anti-fibrotic therapies (pirfenidone or nintedanib).
Participants were randomised to receive either 200mg of BBT-877 twice daily or a placebo.
The trial’s primary goal is to assess BBT-877’s efficacy in IPF patients by analysing the decline in forced vital capacity at week 24 versus placebo.
Secondary objectives include analysing the asset’s safety, pharmacokinetics, diffusing capacity of the lung for carbon monoxide, and functional exercise capacity.
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By GlobalDataBridge Biotherapeutics expects to report topline data from the trial in the first half of next year.
The company is currently seeking a global partnership to prepare for the next phase of the study, which aims to further validate the drug’s efficacy and safety in a larger patient population worldwide.
Bridge Biotherapeutics founder and CEO James Lee said: “The completion of enrolment in the Phase IIa clinical study of BBT-877 marks an important milestone in our efforts to develop innovative treatments for patients suffering from IPF.
“Closely looking for business alliance opportunities in the global pharmaceutical industry, we will remain dedicated to advancing this novel drug candidate, which we believe has the potential to make clinically meaningful outcomes in IPF patients.”
Last year, Bridge Biotherapeutics began a Phase I/II clinical trial of BBT-207 to treat non-small cell lung cancer with epidermal growth factor receptor mutations.
BBT-207 is an epidermal growth factor receptor tyrosine kinase inhibitor designed to hinder the signalling pathway of EGFR with C797S mutations.
