Conatus Pharmaceuticals Inc. (CNAT - Free Report) announced that it has completed enrollment in ENCORE-LF, a phase IIb study evaluating emricasan, a caspase inhibitor, which is being developed for the treatment of patients with decompensatednonalcoholic steatohepatitis (NASH).
The ENCORE-LF study is being conducted in about 210 patients who were randomized 1:1:1 to receive 5 mg of emricasan, 25 mg of emricasan, or placebo twice daily for at least 48 weeks. The primary endpoint is event-free survival. Top-line data from the study is expected to be presented in mid-2019.
Shares of Conatus have plummeted 59.7% in the past year compared with the industry’s decline of 9.7%.
Conatus is conducting three ongoing phase IIb ENCORE studies on emricasan for treating fibrosis or cirrhosis induced by NASH. The programs are called ENCORE-NF (for NASH fibrosis), ENCORE-PH (for portal hypertension) and ENCORE-LF (for liver function).
In December, Conatus announced top-line results from the ENCORE-PH study. In the study, emricasan demonstrated clinically meaningful treatment effects on compensated NASH cirrhosis patients, who stand at a risk of passing to the decompensation state. The study evaluated the capacity of emricasan to reduce hepatic venous pressure gradient (HVPG) in NASH cirrhosis patients. However, the study failed to meet the primary endpoint.
Meanwhile, top-line data from the ENCORE-NF study is expected to be presented in the first half of 2019.
Positive results from these analyses will also pave the way for a phase III efficacy and safety study on the candidate
Please note that emricasan enjoys FDA’s Fast Track status for the treatment of liver cirrhosis caused by NASH. This designation should expedite the review process of the candidate. The candidate also enjoys Orphan Drug status in both the U.S. for the treatment of post-orthotopic liver transplant (POLT) patients with re-established fibrosis to delay the progression to cirrhosis and end-stage liver disease..
Conatus acquired the worldwide rights to emricasan from Pfizer (PFE - Free Report) in July 2010. It has an exclusive option, collaboration and license agreement with Novartis (NVS - Free Report) for the worldwide development and commercialization of emricasan.
Another candidate in Conatus’ portfolio is IDN-7314, which is currently being evaluated in a phase II study for the treatment of primary sclerosing cholangitis (PSC), a chronic liver disease. Notably, the candidate enjoys an Orphan Drug designation (ODD) for the indication in both the United States and the EU.
Zacks Rank & Other Key Pick
Conatus currently carries a Zacks Rank #2 (Buy). Another top-ranked stock in the same sector is Galectin Therapeutics Inc. (GALT - Free Report) , carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Galectin’s loss per share estimates has narrowed from 44 centsto 38 cents for 2019 and from $1.12 to 98 cents for 2020 in the last 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with average of 18.65%.
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