ProMetic Life Sciences has announced positive interim results from its open label phase II clinical trial in patients suffering from idiopathic pulmonary fibrosis (IPF). In addition to demonstrating that PBI-4050 is safe and well-tolerated in patients suffering from IPF, the objective of this study was to provide early evidence of clinical benefits of PBI-4050 treatment whether used alone or in addition to either nintedanib or pirfenidone. Forty patients are enrolled in the study in 6 sites across Canada. At this time, the corporation is reporting on the first 30 patients that have completed their 12 weeks of treatment.
"We are very pleased with the results to date from this study as they provide us with very important data points relating to efficacy and safety," said Dr. John Moran, chief medical officer of ProMetic. "There is early evidence of efficacy in the patients treated with PBI-4050 alone and in those treated with PBI-4050 in combination with one of the commercially available drugs. This compares favorably to that of the pirfenidone or nintedanib treatment reported in the ASCEND trial and in the two INPULSIS trials, respectively. Further good news is the fact that PBI-4050 is very well tolerated by IPF patients whether used alone or in combination with either nintedanib or pirfenidone.”
The comparisons made hereunder between the results in this ProMetic study and the results of three other larger phase III studies undertaken by third parties (i.e. .ASCEND, INPULSIS-1 and INPULSIS-2) are only done to provide some guidance in terms of the potential clinical benefits of PBI-4050 for IPF patients. In the ASCEND and the two INPULSIS studies, IPF patients being treated with pirfenidone or nintedanib saw their Forced Vital Capacity (FVC) decline by approximately -25 ml to -30 ml after 13 weeks of treatment, whilst the FVC of those on placebo declined by -75 ml to -100 ml during the same period.
IPF patients in ProMetic's ongoing clinical trial receiving PBI-4050 alone or PBI-4050 with one of the commercially available drugs for 12 weeks have actually seen a slight improvement in their FVC (~ +10 ml).
Moreover, to date, none of the patients receiving PBI-4050 experienced a decline of ≥10% in FVC or death during the 12 weeks of treatment. In the phase III clinical trial ASCEND the authors reported that 7.5% of patients had a ≥10% decline in FVC or death after 13 weeks of treatment (5% on placebo and 2.5% on pirfenidone treatment).
"As mentioned above, we use the information generated in these three large trials to help us benchmark PBI-4050's performance whether used alone or in combination with the commercial agents," said Dr. Joe Parker, senior director, Clinical Development at ProMetic. "IPF is a terrible condition where patients' lung function keeps declining even when treated by pirfenidone or nintedanib. Our preliminary results are quite encouraging and will help us define the next steps for our promising lead drug candidate PBI-4050," concluded Dr. Parker.