Conatus Pharma Reports Acceptance of Late-Breaking Abstract for AASLD Meeting

Conatus Pharmaceuticals Inc.

today announced that its late-breaking abstract was accepted for a poster presentation at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, November 7-11, 2014. The poster, entitled "Rapid and statistically significant reduction of markers of apoptosis and cell death in subjects with mild, moderate and severe hepatic impairment treated with a single dose of the pan-caspase inhibitor, emricasan," will be presented on Monday, November 10, 2014. The abstract is available at www.aasld.org/. In the abstract, Conatus disclosed that its lead drug candidate, the orally active pan-caspase protease inhibitor emricasan, reduced key biomarkers in a recently completed, single-dose, pharmacokinetic (PK)/pharmacodynamic (PD) Phase 1 clinical trial in subjects with mild, moderate or severe hepatic impairment (defined using the Child-Pugh criteria). Emricasan was administered to 28 subjects with hepatic impairment and 8 matched control subjects, and serial blood samples were collected over a 48 hour period. Levels of three key biomarkers of apoptosis (caspase-cleaved cytokeratin 18), cell death (full-length cytokeratin 18), and caspase enzymatic activity (caspase 3/7) were elevated at study baseline correlating to disease severity, and demonstrated rapid and statistically significant reductions after a single 50 mg oral dose of emricasan in all hepatic impairment subjects. "We are encouraged by emricasan's ability to reduce key disease-elevated biomarkers of caspase activity, apoptosis and cell death rapidly after even a single dose," said Conatus President and Chief Executive Officer, Steven J. Mento, Ph.D. "Our ongoing Phase 2 trials in patients across a broad spectrum of liver disease are designed to assess whether reductions of these potential drivers of liver disease progression result in corresponding clinical benefit." The company is conducting three clinical trials investigating the PK and PD activity of emricasan in patients with impaired organ function to support dose selection and prioritization for advancement in its overall clinical development program: the Phase 1 clinical trial in patients with various degrees of hepatic impairment described above; a Phase 1 clinical trial in patients with severe renal impairment; and a Phase 2b clinical trial in patients with acute-on-chronic liver failure (ACLF) who may have simultaneous impairment of both liver and kidney function as well as other organ involvement. Preliminary PK data from the Phase 1 hepatic impairment trial and Phase 1 severe renal impairment trial were sufficient to identify the appropriate patients for inclusion in a recently initiated Phase 2 clinical trial in patients with liver cirrhosis. Since patients with variable degrees of liver and kidney function are expected to be assessed in future clinical trials, final PK data from all three of the above clinical trials will be evaluated in the aggregate after completion of the ACLF trial, and are expected to inform on optimal dosing of emricasan in future studies in potential target patient populations.