RE:The gap in the IPF race is getting smaller PBI-4050 is an oral compound designed to prevent inflammation and tissue scarring in several organs, including the lungs, kidneys, liver, heart and pancreas. Prometic is developing it not only as a potential treatment for IPF, but also for Alstrm syndrome, metabolic syndrome and chronic kidney disease associated with type 2 diabetes. A pivotal trial is one intended to provide evidence for a drug’s regulatory approval.
A 20-week Phase 2 clinical trial (NCT02538536) showed that PBI-4050, alone or in combination with Ofev (nintedanib; Boehringer Ingelheim), slowed IPF patients’ lung function decline and stabilized their breathing capacity.
The Phase 3 trial will cover people with mild to moderate IPF, including some on Ofev and some who are not. Prometic will not enroll patients on Genentech’s Esbriet (pirfenidone) because a drug-drug interaction between Esbriet and PBI-4050 was reported in previous trials.
Using both patients who are on Ofev and patients who are not in the trial will show whether PBI-4050 is effective alone and in combination with Ofev.
Two groups of patients in the year-long trial will receive one of two doses of PBI-4050 — either 800 mg or 1,200 mg. A third group will receive a placebo.
The trial’s primary objective will be to assess PBI-4050’s ability alone, or in combination with Ofev, to slow patients’ annual rate of decline in a measure of lung function known as forced vital capacity. That is the amount of air a person can force from their lungs after taking the deepest breath possible