Last night French biotech company Genfit released the results of their widely anticipated Phase III study on Elafibranor, a NASH therapeutic that had shown tremendous promise in earlier trials.
Unfortunately, the trial failed to meet both the primary and secondary endpoints. The treated patients response wasn’t statistically meaningful versus the placebo control group. Genfit’s CEO Pascal Prigent said “These results are highly disappointing.” The stock is down by over 65% today.
This setback leaves us with just Abbvie’s cenicriviroc study to look forward to this year, due in late 2020 if there are no delays due to the Covid crisis. Intercept’s Ocaliva is due for FDA approval soon, but seems to have limited effectiveness in specific NASH cases.
The best treatment for NASH and NAFLD remains a healthy diet and lifetsytle changes for the foreseeable future.
On the heels of competitor Madrigal’s excellent trial results another small BioPharma company has released phase 2 results that sent their company stock skyrocketing. Galmed Pharmaceuticals, a small Israeli biopharmaceutical company, produced statistically significant results with a drug called Aramchol in the lowering of fat in the liver at 52 weeks. The analysis of the results was embraced by the markets, which sent the stock soaring 250%.
In one endpoint, more patients treated with 600 mg of Aramchol versus placebo achieved NASH resolution without worsening of fibrosis, at 16.7% versus 5.0% (p=0.0514), respectively, as well as NASH resolution more generally, at 19.2% compared to 7.5% (p=0.0462). In addition, the second biopsy endpoint showed a higher proportion of patients with at least a one-point improvement in fibrosis score without worsening of NASH.
We are at an exciting time for NASH treatment options with multiple companies pursuing promising candidates. People suffering from NASH will still require significant lifestyle changes but hearing about more successful trial results is a very positive step towards getting a grip on the pandemic.