Shares of Conatus Pharmaceuticals Inc. CNAT plunged 50.8% in after-hours trading, after it announced disappointing top-line results from the phase IIb ENCORE-NF study.
Notably, shares of Conatus have plummeted 55.2% in the past six months compared with the industry’s decline of 4.7%.
Conatus is conducting three phase IIb ENCORE studies on emricasan for treating fibrosis or cirrhosis induced by nonalcoholic steatohepatitis (NASH). The programs are named ENCORE-NF (for NASH fibrosis), ENCORE-PH (for portal hypertension) and ENCORE-LF (for liver function).
The randomized, double-blind ENCORE-NF study was initiated in the first quarter of 2016 in patients with biopsy-confirmed NASH and liver fibrosis. The study enrolled and treated 318 patients with biopsy-confirmed NASH Clinical Research Network (CRN) fibrosis stages F1-F3 at baseline.
Patients enrolled in the study were randomized 1:1:1 to receive 5 mg of emricasan, 50 mg of emricasan, or placebo twice daily for 72 weeks. The trial was conducted at 87 U.S. and EU sites.
The trial’s primary endpoint was a ≥1 CRN fibrosis stage improvement without any worsening of steatohepatitis compared with placebo at week 72. However, the candidate did not meet its primary endpoint as it did not have the desired effect on these earlier-stage NASH fibrosis patients.
Nevertheless, the candidate is also being evaluated in more advanced-stage NASH cirrhosis patients. ENCORE-LF is evaluating emricasan in approximately 210 patients with decompensated NASH cirrhosis. The trial was initiated in the second quarter of 2017 and is advancing toward an event-driven analysis of clinical outcome results expected in mid-2019.
Conatus currently has a collaboration agreement with Swiss pharma giant, Novartis AG NVS for the development of emricasan.
The failure of the study is disappointing, given the potential in the NASH market. In December 2018, the ENCORE-PH study also failed to meet the primary endpoint.
Earlier, biotech bigwig Gilead Sciences GILD also announced the failure of a late-stage study on selonsertib, involving patients afflicted with compensated cirrhosis (F4) due to NASH.
Nevertheless, Intercept Pharmaceuticals, Inc. ICPT seems to be winning this race. The company announced positive top-line results from its pivotal phase III REGENERATE study of OCA in patients with liver fibrosis due to NASH. Intercept stated that the primary endpoint of the study — fibrosis improvement without worsening of NASH at 18 months — was achieved with the 25 mg daily dose of OCA. The company plans to file for approval of OCA as a NASH treatment in the United States and Europe in the second half of 2019.
Conatus currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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