In addition to demonstrating that PBI-4050 is safe and very well tolerated, an objective of this study was to seek early evidence of a clinical benefit with PBI-4050 treatment, whether administered alone or in addition to either of the drugs approved for the treatment of IPF, nintedanib or pirfenidone.
These results confirm the preliminary results previously announced by Prometic on November 17, 2016 , following the first 30 subjects' completion of 12 weeks of treatment.
A total of 40 subjects were enrolled in the study conducted in 6 sites across Canada and all have completed the 12 weeks of treatment; 9 subjects received PBI-4050 alone, 16 received PBI-4050 & nintedanib and 15 received PBI-4050 & pirfenidone.
The baseline characteristics of the subjects enrolled in this study were similar to those enrolled in prior IPF randomized controlled studies conducted by other pharmaceutical companies, namely ASCEND and INPULSIS.
As was demonstrated in these previously mentioned large clinical trials, IPF subjects typically experience a progressive decline in respiratory function.
In contrast, in the ProMetic clinical study, the respiratory function of the subjects, measured as the forced vital capacity (FVC (ml)), remained stable after 12 weeks of treatment, in subjects treated with PBI-4050 alone and in those receiving PBI-4050 combined with one of the two approved drugs for the treatment of IPF ("Combi-1") and was superior to that of those subjects treated with PBI-4050 combined with the other approved drug for the treatment of IPF ("Combi-2").
ProMetic chief medical officer Dr. John Moran said: "PBI-4050, either used alone or in Combi-1, demonstrated very promising early indications of efficacy, considering that current drugs approved for IPF only slow (but do not reverse) the decline in lung respiratory function.”
Moran added: "It is also important to note that during our clinical trial, there were no deaths nor did we see any subjects experiencing a decrease in FVC of 10% or more, contrary to the outcomes in the other IPF trials.
“There were no serious adverse events requiring PBI-4050's discontinuation. The most frequent adverse event seen in all groups was diarrhea, but this was clearly much less significant in the subjects treated with PBI-4050 alone than in the groups receiving either of the currently approved drugs for the treatment of IPF, which are well-known for their significant side effect profiles.”
ProMetic President and CEO Pierre Laurin said: "These positive results support the rationale and clinical study design for the placebo controlled, pivotal Phase 2/3 IPF clinical trial we intend to initiate in Q2 2017. We expect to see PBI-4050, alone or in combination with one of the commercially approved IPF drugs, continue to outperform the current drugs in terms of efficacy, safety and tolerability".
The comparisons shown herein between the results in this study and other larger phase 3 clinical studies are only made to provide some provisional guidance in terms of the potential clinical benefits of PBI-4050 for IPF patients.