Replies to post #185543 on Biotech Values

[biomaven0]

Could be that the market has simply ignored FG-3019 until now. It's plausible the drug can reverse fibrosis in some cases, but an easy clinical endpoint has been hard to come by. They've been back-and-forth on the best indication for years now (shuttled between kidney, IPF, pancreatic cancer, liver and now also taking about DMD).

Here's their S1 on liver:

Clinical Development of FG-3019 for Liver Fibrosis
A randomized, placebo-controlled Phase 2 clinical trial is currently being conducted with FG-3019 in 120 patients with HBV-associated liver fibrosis in Hong Kong and Thailand, where the prevalence of HBV is high. The primary endpoint of the trial is change in fibrosis as assessed in liver biopsies. Efficacy data comparing low and high doses of FG-3019 compared to placebo are expected in 2015. A small pilot clinical study in HCV is also being conducted in Hong Kong.
Our future clinical development strategy for liver fibrosis is under active consideration. The need and opportunity for an anti-fibrotic therapy to prevent cirrhosis associated with hepatitis and NASH patients are sizable. However, there is no regulatory consensus on study end-points because clinical manifestations of liver disease do not become apparent until fibrosis is advanced. As with HRCT for pulmonary fibrosis, the imaging technologies are improving for assessment of liver fibrosis, and we are evaluating their applicability to clinical trials for liver fibrosis. There are active efforts by the FDA and liver medical societies to focus on clinical trial design for liver fibrosis and address this challenge. Liver biopsies, the gold standard for measuring liver fibrosis, have significant risks and sample only a small portion of the liver. In a manner similar to our approach to IPF where we assess lung fibrosis by quantitative HRCT, we are currently exploring other non-invasive measurements of overall liver fibrosis, such as magnetic resonance elastography.

In a mouse model they were able to show reversal of radiation-induced lung fibrosis with drug given post-radiation. I think that might still be the only published demonstration of fibrosis reversal. In IPF it worked well in about 25% of patients, with some actually showing modest improvement in both FVC and scans.

Peter