NASH trial update, less competition but Gilead is still in the running, several companies drop out. Does anyone have an update pertaining to the vascepa/Gilead study?
For biotech companies, the NASH boom is threatening to turn into a NASH bust.
Drug companies have been rushing to develop treatments for nonalcoholic steatohepatitis, better known as NASH, a little-known, newly defined disease that affects millions of people in Western countries. But a series of setbacks has dealt a blow to the field, including an announcement in late June by Intercept Pharmaceuticals(ICPT) that the Food and Drug Administration had said that the benefit of its proposed NASH treatment didn't outweigh the potential risks.
Now, the French biotech Genfit(GNFT) , which had been expected to bring one of the first NASH drugs to the market, said it is getting out of the race altogether. In a statement Wednesday evening, Genfit(GNFT) said it was ending a Phase 3 clinical trial of its drug elafibranor in NASH patients. In May, the company had said that an interim analysis had found that the study had failed to meet its primary endpoint.
Genfit (GNFT) went beyond ending the Phase 3 trial of elafibranor in NASH patients. The company said it would now embrace a new corporate strategy, details of which will be announced in September, that will focus on developing elafibranor in another disease, called primary biliary cholangitis, or PBC, and on its NASH diagnostic test.
"We believe the early termination of RESOLVE-IT is the appropriate decision from an ethical and clinical perspective, and this decision will contribute to accelerating cost savings and to focusing our efforts on our two top priorities," CEO Pascal Prigent said in a statement.
Shares of Genfit(GNFT) rose 3.9% Thursday morning to $5.63 as the S&P 500 slipped 0.1%. The stock fell 74.5% between May 1 and the close of trading on Wednesday, following news of the failure of the Phase 3 trial. Genfit(GNFT) shares are down 69.7% this year, compared with a 5.8% drop for the Dow Jones Industrial Average.
Analysts praised the news of the termination of the Phase 3 trial, and the new focus for the company. Stifel analyst Derek Archila upgraded the stock to Buy from Hold on the news.
"In light of the negative interim results for elafibranor in NASH patients with fibrosis, we think it is prudent for GNFT to be terminating [the NASH trial] to refocus on PBC, an opportunity underappreciated by the Street," Archila wrote.
Barron's urged skepticism of the NASH race in a magazine feature in December. Since then, key players have stumbled. Intercept shares (ICPT) are down 63.1% this year.
Other companies, though, have reported some promising results. The small biotech Akero Therapeutics(AKRO) announced positive data from a Phase 2 study of its drug efruxifermin in NASH patients in late June. The stock is up 57.6% this year.
Other drugmakers developing NASH drugs include Alnylam (ALNY) and Gilead Sciences(GILD) .
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
