Conatus Pharmaceuticals Inc (NASDAQ:CNAT) announced the initiation of active patient recruitment in ENCORE-NF, a randomized, double-blind, placebo-controlled, Phase 2b clinical trial evaluating emricasan, the company’s first-in-class, orally-active pan-caspase inhibitor, in approximately 330 patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) and stage 1 to 3 fibrosis using the NASH Clinical Research Network (CRN) Histologic Scoring System. This trial is designed to evaluate differentiated dosing and establish efficacy of emricasan in the large and growing NASH fibrosis market as well as add long-term safety data in support of the company’s initial registration focus in liver cirrhosis.
The ENCORE-NF clinical trial is expected to be conducted at approximately 90 U.S. and EU clinical sites. Patients will be randomized 1:1:1 to receive 5 mg of emricasan, 50 mg of emricasan, or placebo twice daily for 72 weeks. The 5 mg and 50 mg doses have previously been shown to be equally effective in reducing ALT, AST and mechanism-specific biomarkers in patients with liver fibrosis, while the 50 mg dose may provide additional benefit in patients with liver cirrhosis. The primary endpoint is a biopsy-based improvement in fibrosis by at least one stage vs. placebo using NASH CRN without worsening of steatohepatitis. Secondary endpoints include resolution of steatohepatitis without worsening of fibrosis, nonalcoholic fatty liver disease (NAFLD) activity score (NAS) and its components (steatosis, lobular inflammation, and ballooning), collagen and fat content by biopsy, key serum biomarkers, and health-related quality of life, as well as safety and tolerability of emricasan. Top-line results from the ENCORE-NF clinical trial are expected in 2018.
“With ENCORE-NF, we are evaluating emricasan’s potential to provide histological benefit and product differentiation in these patients to establish a development path forward in NASH fibrosis,” said Conatus co-founder, President and Chief Executive Officer Steven J. Mento, Ph.D. “Emricasan’s mechanism of action targets both apoptosis and inflammation, both of which are key drivers of liver fibrosis in NASH. In preclinical models of NASH and NAFLD, emricasan treatment improved liver histology, including reductions in both liver fibrosis and liver inflammation. Emricasan also reduced mechanism-specific biomarkers and serum levels of ALT and AST. In our NAFLD/NASH clinical trial reported in 2015, emricasan treatment afforded statistically significant reductions in ALT, AST and in mechanism-specific biomarkers. We believe these combined results provide a strong scientific rationale supporting the clinical development of emricasan in patients with NASH fibrosis.”
The ENCORE-NF clinical trial is the first of multiple parallel EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) Phase 2b clinical trials designed to evaluate multiple doses of emricasan over various treatment durations in chronic liver disease of different etiologies and disease stages. The ENCORE trials are designed to provide clinically relevant efficacy, dosing, and safety data to support the initial registration of emricasan for chronic administration in patients with liver cirrhosis. Results from the combined ENCORE clinical trials are expected to support the design of Phase 3 efficacy and safety trials, but could warrant earlier discussions with regulatory agencies regarding potential accelerated approval. Conatus expects to initiate the remainder of these trials on a staggered basis through early 2017 and expects top-line results from the ENCORE clinical trials to be available periodically beginning in the first half of 2018. (Original Source)
Shares of Conatus Pharmaceuticals closed last Friday at $2.29, down $0.17 or -6.91%. CNAT has a 1-year high of $8.46 and a 1-year low of $2.25. The stock’s 50-day moving average is $2.92 and its 200-day moving average is $4.02.
On the ratings front, Conatus has been the subject of a number of recent research reports. In a report issued on January 6, Roth Capital analyst Elemer Piros reiterated a Buy rating on CNAT, with a price target of $15, which implies an upside of 555.0% from current levels. Separately, on the same day, Brean Murray Carret’s Difei Yang reiterated a Buy rating on the stock and has a price target of $13.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Elemer Piros and Difei Yang have a total average return of -27.8% and -13.5% respectively. Piros has a success rate of 15.6% and is ranked #3552 out of 3610 analysts, while Yang has a success rate of 26.6% and is ranked #3553.
The street is mostly Bullish on CNAT stock. Out of 4 analysts who cover the stock, 4 suggest a Buy rating . The 12-month average price target assigned to the stock is $7.50, which represents a potential upside of 227.5% from where the stock is currently trading.
Conatus Pharmaceuticals Inc is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease.