ProMetic’s Therapy for IPF Receives FDA Approval for More Clinical Trials
ProMetic Life Sciences’s lead product for the treatment of idiopathic pulmonary fibrosis (IPF), called PBI-4050, is going to be tested in a Phase 2/3 clinical trial.
Supported by efficacy data from a Phase 2 study (NCT02538536), the U.S. Food and Drug Administration (FDA) has accepted the application for new clinical trials for PBI-4050.
Headquartered in Laval, Canada, ProMetic is a biopharmaceutical company focused on the development and marketing of new small-molecule therapeutic products to target unmet medical needs, especially in fibrosis, anemia, neutropenia, cancer, autoimmune and inflammatory diseases.
One of the company’s lead compounds, PBI-4050, has shown promising results targeting fibrosis in animals models. This new drug can perform its anti-fibrotic activities in several tissues, including kidneys, heart, lungs, and liver, with good safety and effectiveness profiles.
In the latest Phase 2 study, PBI-4050 was given to 40 IPF patients either alone or in combination with Esbriet (pirfenidone) or Ofev (nintedanib). Those who received the drug alone or in combination with Ofev presented a stable respiratory capacity, measured by forced vital capacity (FVC). In comparison, patients receiving PBI-4050 combined with Esbriet got worse, with a decline in their FVC, suggesting a negative drug-drug interaction effect.
“To date, PBI-4050 has presented a remarkable safety and tolerability profile throughout all clinical trials,” Pierre Laurin, president and CEO of ProMetic, said in a press release. “We are also very pleased that our Phase 2 open label study in IPF patients has served the very important strategic purpose of allowing us to optimize the design of our pivotal clinical program for this devastating medical condition.”
The FDA has approved additional placebo-controlled clinical trials where IPF patients currently treated with Ofev would receive PBI-4050 or a placebo. This will discriminate possible beneficial effects of ProMetic’s new drug to the current standard IFP treatment.
“This early evidence of efficacy observed with PBI-4050 alone or in combination with nintedanib [Ofev] points toward very promising treatment options that will be further tested in two separate phase 2/3 clinical trials,” said John Moran, chief medical officer of ProMetic. “We are very pleased that the FDA concurs with our decision to exclude a combined pirfenidone [Esbriet] and PBI-4050 treatment arm in the upcoming phase 2/3 add-on study.”
In addition, ProMetic plans to initiate a second phase 2/3 placebo-controlled trial to test the effectiveness of PBI-4050 in a monotherapy regimen in IPF patients who have failed to tolerate other commercialized drugs, such as Ofev and Esbriet.
