Conatus Pharmaceuticals Soars on Positive Phase 2 Results

By Chris Lange September 24, 2015 Updated September 24, 2015

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Conatus Pharmaceuticals Inc. (NASDAQ: CNAT) made waves early Thursday morning with the release of positive results from a recent study. The company announced that its exploratory Phase 2 portal hypertension (PH) clinical trial of emricasan, a first-in-class, orally active pan-caspase inhibitor, met its primary endpoints.

The key endpoint in the study was a statistically significant change from baseline in cleaved cytokeratin 18 (cCK18), a mechanism-specific biomarker of excessive cell death that contributes to chronic inflammation, in the total evaluable liver cirrhosis patient population.

For some background on the company: Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease.

David T. Hagerty, M.D., Executive Vice President of Clinical Development at Conatus, commented on the study:

We were excited to demonstrate that a drug candidate with the potential to achieve long-term resolution of fibrosis and cirrhosis also has the ability to induce a rapid and clinically meaningful reduction of severe portal hypertension. The reduction of portal pressure over a relatively short time frame in the patients with therapeutically relevant portal hypertension may reflect the initial impact of emricasan on the hyperdynamic circulation that is the predominant contributor to portal hypertension as cirrhosis progresses and/or a direct effect upon intrahepatic vasculature resistance. Future studies will be needed to assess the relative contribution of these mechanisms to the observed clinical effect. Decreasing HVPG has been identified by the FDA (U.S. Food and Drug Administration) as a validated, objective measure that may be acceptable as a surrogate endpoint for clinical trials of patients with liver cirrhosis. These results set the stage for future Phase 2b clinical trials in patients with cirrhosis and therapeutically relevant portal hypertension.

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Conatus co-founder, President and Chief Executive Officer Steven J. Mento, Ph.D. added:

We believe the results from this trial establish the near-term effects of emricasan on portal hypertension. We are evaluating emricasan’s potential longer-term effects on liver function and liver structure in our other two ongoing clinical trials: the Phase 2 Liver Cirrhosis (LC) trial and the Phase 2b post-transplant trial.

Shares of Conatus closed Wednesday up 15.7%, at $5.74 in a 52-week trading range of $3.44 to $11.74. In early trading indications Thursday, shares were up 24.6% at $7.15. The stock has a consensus analyst price target of $12.00.