LAVAL, QC – Prometic Life Sciences Inc. has received concurrence from the U.S. Food and Drug Administration (FDA) on the design of the first of its PBI-4050’s planned phase 2/3 clinical trials for idiopathic pulmonary fibrosis based on the efficacy data generated in the recently completed 40 patient Phase 2 open-label study.
In that Phase 2 study, PBI-4050 was given for 12 weeks to patients who were receiving pirfenidone, nintedanib, or neither agent. The results of the study showed that the Forced Vital Capacity (FVC) remained stable in patients on PBI-4050 alone (n=9, FVC -12 ml) or in patients on PBI-4050 in combination with nintedanib (n=15, FVC +2 ml). In contrast, the results of said study showed that the FVC declined significantly in patients on PBI-4050 in combination with pirfenidone (n=16, FVC -105 ml). PBI-4050’s plasma concentration was sub-therapeutic at 50 per cent of the expected level in patients that received the PBI-4050 and pirfenidone combination, suggesting a drug-drug interaction.
“This early evidence of efficacy observed with PBI-4050 alone or in combination with nintedanib points toward very promising treatment options that will be further tested in two separate phase 2/3 clinical trials,” Dr. John Moran, chief medical officer of Prometic commented. “We are very pleased that the FDA concurs with our decision to exclude a combined pirfenidone and PBI-4050 treatment arm in the upcoming phase 2/3 add-on study.”
The design for the add-on placebo-controlled phase 2/3 pivotal trial will therefore be an amended version of the protocol the FDA originally requested during the pre-IND meeting: IPF patients currently treated with nintedanib would be randomized to receive in addition either PBI-4050 or a placebo.
Prometic also intends to initiate a second phase 2/3 placebo-controlled trial which would enroll IPF patients who have failed to tolerate nintedanib or pirfenidone and would be randomized to receive either PBI-4050 or placebo, (PBI-4050 Monotherapy).