Canada-based Prometic Life Sciences has secured investigational new drug (IND) approval from the US Food and Drug Administration (FDA) to evaluate its drug candidate PBI-4050 in a Phase II/III clinical trial to treat idiopathic pulmonary fibrosis (IPF) patients in the country.
PBI-4050 is an orally active agent with proof-of-concept data confirming its anti-fibrotic activity in various vital organs such as kidneys, heart, lungs, and liver.
The two-stage adaptive, randomised, double-blind, placebo-controlled Phase II/III trial will assess the safety and efficacy of PBI-4050 in combination with Boehringer Ingelheim’s nintedanib.
Prometic Life Sciences president and CEO Pierre Laurin said: “We are very excited to be entering the pivotal stages of our IPF clinical programme, which is another important milestone towards bringing this therapy to patients who suffer from IPF.
“We believe that PBI-4050 is an important advancement in this indication and represents a potential significant step forward for helping patients.”
The Phase II part of the trial will recruit a total of 375 patients, 125 of which will receive placebo plus nintedanib, while another 125 will be treated with 800mg of PBI-4050 plus nintedanib and the remaining 125 with 1,200mg of PBI-4050 plus nintedanib.
An interim analysis for safety and efficacy will be conducted at week 26 to determine continuation of the evaluation into the Phase III part of the trial.
The Phase III part will include an additional 450 subjects who will be administered with a selected dose of PBI-4050 or with a combination of placebo and nintedanib.
In a previous Phase II trial of PBI-4050 with pirfenidone, nintedanib or placebo for 12 weeks, stable forced vital capacity (FVC) was observed in patients treated with PBI-4050 alone and with PBI-4050 plus nintedanib.
The firm plans to submit clinical trial applications for the drug candidate in Canada, Europe, Australia and Japan in the fourth quarter of this year.