ProMetic Life Sciences recently announced that the U.S. Food and Drug Administration (FDA) agreed with the design of the first Phase 2/3 clinical trials evaluating PBI-4050 for idiopathic pulmonary fibrosis (IPF) treatment.
PBI-4050 is an oral drug designed to treat fibrosis, a condition characterized by the replacement of normal tissue by fibrotic scar tissue.
The planned Phase 2/3 clinical trials for IPF are based on positive Phase 2 trial results of the drug’s effectiveness and tolerability as a monotherapy and in combination with Ofev (nintedanib) or Esbriet (pirfenidone).
This open-label, single-arm, Phase 2 clinical trial (NCT02538536) enrolled 40 IPF patients and assessed the effectiveness, safety, and tolerability of PBI-4050 (800 mg daily, oral administration) on lung function and disease progression.
Results reported in February showed that after 12 weeks of treatment, the forced vital capacity (FVC, a measure of lung function) remained stable in patients treated with PBI-4050 alone (nine patients), and in patients treated with PBI-4050 in combination with Ofev (15 patients). In patients treated with PBI-4050 in combination with Esbriet (16 patients), FVC declined significantly.
The plasma concentration of PBI-4050 was sub-therapeutic at 50 percent of the expected level in patients that received the PBI-4050 in combination with Esbriet, indicating negative drug-drug interaction.
“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. 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,” John Moran, chief medical officer of ProMetic said in a press release.
In the new study, planned to begin in a few months, IPF patients currently treated with Ofev will be randomly assigned to additional treatment with either PBI-4050 or a placebo.
The company is also considering conducting another Phase 2/3 placebo-controlled clinical trial with PBI-4050 in IPF patients who did not tolerate Ofev or Esbriet.
“To date, PBI-4050 has presented a remarkable safety and tolerability profile throughout all clinical trials,” said Pierre Laurin, president and CEO of ProMetic. “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.”
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?