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If Phase II data is replicated (or even improved on with more frequent dosing) in larger Ph III against perf/nin, trial is a layup

What do think would be the best P3 trial design?

Would the FDA allow a non-inferiority open label trial against pirfenidone or nintedanib or would they want both?

A non-placebo trial would enroll the fastest so I'm guessing that's the way to go.

ITMN's perfenidone P3 placebo controlled trial enrolled 550 pts randomized 1:1...
http://www.prnewswire.com/news-releases/intermune-reports-phase-3-ascend-trial-results-of-pirfenidone-in-idiopathic-pulmonary-fibrosis-ipf-247036021.html

BTW - this meta-analysis suggest perfenidone is superior to nintednib...

Systematic Review and Network Meta-analysis of Idiopathic Pulmonary Fibrosis Treatments.

https://www.ncbi.nlm.nih.gov/pubmed/28287346

Patients treated with pirfenidone also had a lower risk of experiencing a decline in percent predicted FVC of = 10% over 1 year (odds ratio [OR]: 0.58, 95% CrI = 0.40-0.88), whereas there was no conclusive evidence of a difference between nintedanib and placebo (OR: 0.65, 95% CrI = 0.42-1.02).

The NMA indicated that pirfenidone reduced all-cause mortality relative to placebo over 1 year (hazard ratio [HR]: 0.52, 95% CrI = 0.28-0.92). There was no evidence of a difference in all-cause mortality between nintedanib and placebo (HR: 0.70, 95% CrI = 0.32-1.55),