Fibrogen (NASDAQ:FGEN) faces hurdles to advance pamrevlumab in idiopathic pulmonary fibrosis (IPF) beyond its Phase IIb results, experts said.
Fibrogen may struggle to execute a robust randomized trial and may be hoping for acquisition interest after releasing Phase IIb data, a source said, while a pulmonologist who was familiar with company strategy pointed to its struggles after the 2014 approvals of Boehringer Ingelheim’s Ofev (nintedanib) and Roche’s (VTX:ROG) Esbriet (pirfenidone) and their adoptions as SOC.
Pamrevlumab faces challenges to show efficacy combined with SOC and generate enough data to show superiority over SOC alone in a pivotal study, experts said. While one expert said pamrevlumab could overcome challenges to show combination efficacy through non-traditional endpoints, others said these are not clinically validated.
The 103-patient Phase IIb (NCT01890265) placebo-controlled randomized monotherapy study modified to include an additional 57-patient sub-study with pamrevlumab in combination with SOC compared to SOC monotherapy is ongoing. Fibrogen expects topline results from both in 3Q17, said Seth Porter, vice president, fibrosis therapeutics, Fibrogen.
Analysts remain reserved, with some expecting USD 1.5bn in sales, but BioPharm Insight previously reported the study would struggle to show clinically meaningful efficacy due to IPF patient variability and a combination therapy’s higher success bar.