Conatus Pharmaceuticals Inc. (CNAT) stock fell over 50% today amid disappointing results for the company’s 2b ENCORE-PH clinical trial in NASH cirrhosis. During the 24-week trial, results repeatedly favored the drug emricasan compared to placebo, yet did not meet the primary endpoint of changing the mean hepatic venous pressure gradient (HVPG) from the baseline.
The study consisted of two patient groups, one group has compensated NASH cirrhosis and the other with early decompensated NASH cirrhosis. Chief Executive Officer and co-founder of the biotech, Steven J. Mento commented on the experience: “Based on previous discussions with regulators, we expect that separate registration trials would be needed in compensated and decompensated NASH cirrhosis. This trial purposely enrolled mostly compensated patients, and we are encouraged by the treatment effect shown in this population in these top-line results.”
Post hoc analysis finds patients with compensated NASH cirrhosis showed consistent improvements in mean HVPD. The significance of the improvement in mean HVPG typically increased as the baseline HVPG levels increased. The doses of 25mg and 50mg both gained a 10% improvement in mean HVPG when comparing to the placebo, while patients using the placebo showed increases in mean HVPG. Arun Sanyal, Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University School of Medicine, chair of the NIH NASH Clinical Research Network, and chair of the Liver Forum weighed in on the updates:
“This trial evaluated the ability of emricasan to reduce HVPG in patients with cirrhosis due to NASH. Although the primary endpoint was not met, the data indicates an amelioration of portal pressures by emricasan,” said Arun Sanyal, M.B.B.S, M.D., Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University School of Medicine, chair of the NIH NASH Clinical Research Network, and chair of the Liver Forum. “Not surprisingly, those with the highest HVPG had the greatest benefit and the trends in all groups on sensitivity analyses favored active therapy. Together, these suggest that the findings are real and support additional investigation of this compound for those with compensated cirrhosis due to NASH and high HVPG, i.e., the population at greatest risk of clinical decompensation for whom there are no alternate approved therapies.”
Patients who enrolled in the ENCORE-PH clinical trial will continue treatment or placebo for a six-month extension period to evaluate longer-term safety, liver function and clinical outcomes. Results on the extension trial are expected for mid 2019.
TipRanks reviewed what analysts are saying about this stock. Out of three analysts who rated this stock, two are bullish and one is sidelined. The consensus rating is a Moderate Buy, with a $9.33 price target, which shows an upside of about 336%. (See CNAT’s price targets and analyst ratings on TipRanks)