SAN DIEGO, March 23, 2015 (GLOBE NEWSWIRE) — Conatus Pharmaceuticals Inc. (CNAT) and its research collaborator BioReliance, Sigma-Aldrich Corporation’s (SIAL) biologics and early-development services business, are presenting a poster today at the 54th Annual Meeting of the Society of Toxicology (San Diego — March 22-26, 2015). The poster, entitled “Carcinogenicity Assessment of the Pan-Caspase Inhibitor, Emricasan, in Tg.rasH2 Mice,” will be available for viewing in the Exhibit Hall of the San Diego Convention Center today, Monday, March 23, 2015, from 1:00 p.m. to 4:30 p.m. PT,and the authors will be available for discussion at the poster from 1:00 p.m. to 2:45 p.m. PT. The poster is available on the Events & Presentations page in the Investor Center of the Conatus website at www.conatuspharma.com.
The poster describes previously announced results of a rigorous six-month evaluation of emricasan, Conatus’ orally active, irreversible pan-caspase protease inhibitor, in the Tg.rasH2 humanized mouse model, which is highly prone to developing cancer. Tg.rasH2 mice were fed 0, 10, 25, and 75 mg/kg/day of emricasan for 26 weeks. There were no treatment related deaths or overt signs of toxicity for the duration of the study. There was no evidence of emricasan-related tumor formation in any tissue. The primary conclusion of the study, which was completed in 2012, was that emricasan did not increase the incidence of neoplastic lesions in Tg.rasH2 mice and is thus considered to have no carcinogenic potential in human.
“Because of emricasan’s potent ability to reduce excessive apoptosis and inflammation, we wanted to address historical, theoretical concerns about cancer with a conclusive carcinogenicity study to supplement our extensive safety database in humans,” said Conatus co-founder, Executive Vice President of Research and Chief Scientific Officer, Alfred P. Spada, Ph.D. “We are very pleased to report results from this important study, which generated solidly positive data that directly and successfully addressed the theoretical concern regarding the carcinogenic potential of emricasan.”
About Emricasan Clinical Development
To date, emricasan has been studied in more than 550 subjects in thirteen clinical trials. In a completed Phase 2b clinical trial, emricasan consistently demonstrated statistically significant, rapid and sustained reductions in elevated levels of key biomarkers of inflammation and apoptosis that are implicated in the severity and progression of liver disease. Importantly, these key biomarkers are known to be elevated and to have prognostic value in multiple hepatic indications that Conatus is currently pursuing. Conatus is developing emricasan for the treatment of patients with chronic liver disease, including four ongoing Phase 2 clinical trials in these various liver disease patient populations:
- patients with nonalcoholic fatty liver disease (NAFLD), including the subset of NAFLD patients with inflammatory and/or fibrotic nonalcoholic steatohepatitis (NASH), for which top-line results are expected in the first quarter of 2015;
- post-orthotopic liver transplant (POLT) recipients with liver fibrosis post-transplant as a result of recurrent hepatitis C virus (HCV) infection who have successfully achieved a sustained viral response (SVR) following HCV antiviral therapy (POLT-HCV-SVR), for which initial baseline data are expected in the second quarter of 2015;
- patients with liver cirrhosis (LC) and portal hypertension (PH), for which top-line results are expected in the third quarter of 2015; and
- patients with LC and Model for End-stage Liver Disease (MELD) scores of 11 to 18, for which initial results are expected in the fourth quarter of 2015.
These ongoing clinical trials are expected to confirm and refine the most appropriate initial registration pathway, subject to regulatory agency discussions.
About Conatus Pharmaceuticals
Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. Conatus is developing its lead compound, emricasan, for the treatment of patients with chronic liver disease. Emricasan is a first-in-class, orally active pan-caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and apoptosis. Conatus believes that by reducing the activity of these enzymes, emricasan has the potential to interrupt the disease progression across the spectrum of liver disease. For additional information, please visit www.conatuspharma.com.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward looking statements, including statements regarding: the timeline to announce top-line results from the Phase 2 NAFLD/NASH clinical trial; the timeline to announce initial baseline data from the POLT-HCV-SVR Phase 2b clinical trial; the timeline to announce top-line results from the Phase 2 PH clinical trial; the timeline to announce initial results from the Phase 2 LC clinical trial; the ability to confirm and refine the most appropriate initial registration pathway, subject to regulatory agency discussions, based on the company’s ongoing clinical trials; and emricasan’s therapeutic potential in patients with liver disease. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including: Conatus’ ability to initiate and successfully complete current and future clinical trials; Conatus’ dependence on its ability to obtain regulatory approval for, and then successfully commercialize emricasan, which is Conatus’ only drug candidate; Conatus’ reliance on third parties to conduct its clinical trials, enroll subjects, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of emricasan, if approved; the potential that earlier studies may not be predictive of future results; potential adverse side effects or other safety risks associated with emricasan that could delay or preclude its approval; Conatus’ ability to obtain orphan drug exclusivity for emricasan for any indication; results of future clinical trials of emricasan; the potential for competing products to limit the clinical trial enrollment opportunities for emricasan in certain indications; the uncertainty of the U.S. Food and Drug Administration’s and other regulatory agencies’ approval processes and other regulatory requirements; Conatus’ ability to fully comply with numerous federal, state and local laws and regulatory requirements applicable to it; Conatus’ limited operating history and its ability to operate successfully as a public company; Conatus’ ability to obtain additional financing in order to complete the development and commercialization of emricasan; and those risks described in Conatus’ prior press releases and in the periodic reports it files with the Securities and Exchange Commission. The events and circumstances reflected in Conatus’ forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Conatus does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.