Preliminary comments — PHASE 3 PIVOTAL CLINICAL TRIAL FOR IDIOPATHIC PULMONARY FIBROSIS
—* This is a large worldwide pivotal trial. From its design, and approval by FDA, we can infer some confidence by Prometic and the regulator.
—* As we've seen in other PBI-4050 trials, there will be leaks by and from patients experiencing improvement. Despite the fact that preliminary results are 26 weeks after inception, we'll probably get an early but unquantified sense of success (or failure) before then.
—* There are three trial arms - low dose 4050, high dose 4050, and placebo.
— Notes:
— A — Patients taking pirfenidone will be excluded because of a known drug-drug interaction between pirfenidone and PBI-4050.
— B — The enrollment criteria will be greatly simplified such that the study will enroll patients with mild-to-moderate IPF, regardless of whether they are on background standard of care with nintedanib (OFEV®) or not. Therefore, the study will provide efficacy data on both PBI-4050 as a stand-alone agent, and as an add-on to nintedanib, and will be part of the dataset to support a simple, all-inclusive indication “for the treatment of IPF”.
—* The trial will be expensive. Questions of cost and partnerships continue. Opinion -- a partnership seems unlikely until preliminary results (at least) are in.
—* By drug industry standards, this is an accelerated path to possible approval:
Oct. 25, 2017
PROMETIC RECEIVES FAST TRACK DESIGNATION FOR PBI-4050 IN DEVELOPMENT FOR IDIOPATHIC PULMONARY FIBROSIS (IPF)
January 29, 2018
PROMETIC’S PBI-4050: PHASE 3 PIVOTAL CLINICAL TRIAL DESIGN FOR IDIOPATHIC PULMONARY FIBROSIS (IPF) FINALIZED
—* The MOA for PBI-4050 may be revealed at today's KEY OPINION LEADER MEETING. As of this moment it's still not known. That said, it seems unlikely that FDA would have approved a pivotal trial without knowing the MOA.
Further comments after the Key Opinion Leader meeting.
Jim
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