Pirfenidone release published earlier

[Guest guest]

Ken put a document issued by Intermune in the files section. This was related to the pirfenidone trial. Now, the application to the FDA is still to be submitted and may or may not be approved. While the Intermune release paints a favorable picture and there is some positive, I'm sure its not to the extent hoped for.

Following is data pulled from their document:

Summary of Pirfenidone Release

There were two trials conducted with a total of 779 patients. The median age of participants was 67 years old, 72% were male. Over 90% were decided to be IPF by HRCT. Just over 50% had been determined by biopsy. The median percent FVC (forced vital capacity) of the participants was 73%. In the first of the trials approximately 28% were on oxygen and in the second approximately 17%. So, in total your demographics were older, primarily male and early stage IPF.

The primary endpoint measurement for the trial was FVC at the end of 72 weeks. In the first trial there was not a statistically valid difference between the PFD and the Placebo group (PFD group dropped about 10% less than the placebo group in FVC during the trial). In the second trial the PFD group had approximately 32% less drop in FVC (6.49 vs. 9.55). In both trials the difference between the PFD group and the placebo group was over 50% in the first 36 weeks much of that gap was closed during the second 36 weeks.

76% of the participants on PFD declined during the trial while 82% of the placebo participants declined. (As to declines of greater than 20%, 10% of the PFD participants encountered such versus 14% of the placebo participants). 25% of the participants on PFD improved (not equal to 100% total due to rounding) while 18% of the placebo participants improved. However, no patients improved more than 20% and only 1.5% of both PFD and placebo patients improved more than 10%.

7.8% of the PFD participants within their first 72 weeks on the study died versus 9.8% of the placebo participants. Over 98% of participants on both PFD and the placebo experienced treatment emergent adverse events during the trial. 33% of those on PFD versus 32% of those on the placebo experienced at least one serious adverse event. 11% of those on PFD and 11% of those on the placebo died. (Note some patients were in the study beyond 72 weeks while others were reaching 72 weeks).

As to side effects, I shall list the percent with various side effects on PFD versus those with the placebo shown on brackets. Nausea 37% (17%), Rash 32% (11%), Fatigue 30% (21%), Diarrhea 29% (19%), Dyspepsia 19% (8%), Dizziness 19% (10%), Reflux 11% (8%), Photosensitivity 12% (1%), Vomiting 14% (5%), Insomnia 10% (7%), Arthralgia 11% (7%), Anorexia 11% (4%), UTI 10% (9%), Distension 10% (6%).

Certainly the FDA will have much more detailed data to analyze and maybe there will be extended studies but about all this data they provided today would show is as follows: In a primarily older male group of persons with mild, early stage IPF, Pirfenidone (PFD)appeared to slow the reduction of the FVC during the first 36 weeks of use, losing some of that advantage during the next 36 weeks. PFD did have several side effects but during the 72 week period they did not appear to lead to death. Almost all patients in both the PFD and placebo group did experience some adverse events during the trial and approximately 1/3 had serious adverse events with no statistical significant difference between the PFD group and the placebo group.