An oral anti-fibrotic drug candidate, PBI-4050, has received FDA Investigational New Drug (IND) approval to commence its pivotal Phase 2/3 clinical trial in patients suffering from idiopathic pulmonary fibrosis (IPF), according to Prometic Life Sciences Inc.
The pivotal Phase 2/3 clinical trial is a two-stage adaptive, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of PBI-4050 when combined with nintedanib (Ofev, Boehringer Ingelheim) in subjects with IPF.
The number of subjects required to be enrolled has been based on the results seen in the recently-completed open label study of PBI-4050 in IPF. The Phase 2 stage will enroll 375 subjects with IPF, who will be randomly assigned to one of three groups:
- 125 subjects who will receive placebo + nintedanib;
- 125 subjects who will receive PBI-4050 800 mg + nintedanib; or
- 125 subjects with PBI-4050 1200 mg + nintedanib.
An independent Data and Safety Monitoring Board (DSMB) will conduct an interim 26-week analysis, and based on the safety and efficacy results, will recommend whether the study should continue into Phase 3 stage and which dose of PBI-4050 should be continued. This Phase 3 stage would randomize an additional up to 450 subjects to receive nintedanib plus either placebo or the chosen PBI-4050 dose.