(CNAT) FDA Grants Conatus Fast Track Designation

Focusing on Initial Registration in NASH Cirrhosis With Parallel Development in NASH Fibrosis

SAN DIEGO, Feb. 03, 2016  — Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s emricasan development program for the treatment of liver cirrhosis caused by nonalcoholic steatohepatitis (NASH). Based on additional communications with the FDA recommending single-etiology clinical trials, the company plans to focus on advancing toward initial registration of emricasan for patients with NASH cirrhosis, with parallel development toward registration of emricasan for patients with NASH fibrosis, and supportive clinical trials addressing additional patient populations.

The Fast Track program provides for greater access to FDA to facilitate development and expedite review of drugs that have demonstrated the potential to treat serious or life-threatening conditions. “The data from our recently completed Portal Hypertension trial, showing clinically meaningful reductions in hepatic venous pressure gradient (HVPG) in patients with severe portal hypertension after only one month of treatment with emricasan, were a key component of our Fast Track submission,” said Conatus co-founder, President and Chief Executive Officer Steven J. Mento, Ph.D. “The Fast Track designation formalizes the recognition of emricasan’s potential to address a significant unmet medical need, but we believe its real importance is in the opportunity for even closer interactions with the FDA as we pursue the most efficient pathway to provide a potentially disease-modifying treatment to patients with NASH cirrhosis.”

About Emricasan Clinical Development

To date, emricasan has been studied in over 650 subjects in sixteen clinical trials across a broad range of liver disease etiologies and stages of progression. In multiple clinical trials, emricasan has demonstrated statistically significant, rapid and sustained reductions in elevated levels of key biomarkers of inflammation and apoptosis that are implicated in the progression of liver disease. Recent clinical trial results have demonstrated emricasan’s ability to provide statistically significant improvements in clinically important validated functional surrogate endpoints of portal hypertension and liver function across a variety of etiologies in the subgroups of liver cirrhosis patients with highest medical need. In November 2015, the company announced plans to conduct a set of parallel EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) 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 further information on doses leading to clinically relevant efficacy, including improvement in biopsy-proven fibrosis and inflammation in patients with NASH fibrosis, and improvement in severe portal hypertension and hepatic function in patients with NASH cirrhosis. The ENCORE trials are also designed to provide safety data to support the initial registration of emricasan for chronic administration in patients with liver cirrhosis. The company’s recently initiated Phase 2b ENCORE-NF clinical trial is evaluating emricasan’s potential longer-term benefits for patients with liver fibrosis resulting from NASH. The company also is evaluating emricasan’s potential longer-term benefits on liver fibrosis and cirrhosis in its ongoing Phase 2b clinical trial in post-orthotopic liver transplant (POLT) recipients who developed liver fibrosis or cirrhosis post-transplant as a result of recurrent hepatitis C virus (HCV) infection and who have successfully achieved a sustained viral response (SVR) following antiviral therapy (POLT-HCV-SVR).

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 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.

Forward-Looking Statements

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 company’s focus on initial registration of emricasan for patients with NASH cirrhosis; development toward registration of emricasan for patients with NASH fibrosis; supportive clinical trials addressing additional patient populations; emricasan’s potential to address a significant unmet medical need; the opportunity for closer interactions with the FDA; emricasan’s disease-modifying potential as a treatment for patients with NASH cirrhosis; the company’s plans to conduct the ENCORE set of parallel clinical trials; the ability of the ENCORE trials to provide dosing information leading to clinically relevant efficacy in patients with NASH fibrosis and NASH cirrhosis, and safety data to support the initial registration of emricasan for chronic administration; emricasan’s potential longer-term benefits for patients with NASH fibrosis; emricasan’s potential longer-term benefits on liver fibrosis and cirrhosis in POLT-HCV-SVR patients; and emricasan’s potential to interrupt the disease progression across the spectrum of 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; 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.

 

MEDIA:  David Schull
Russo Partners, LLC
(858) 717-2310
David.Schull@RussoPartnersLLC.com

INVESTORS:  Alan Engbring
Conatus Pharmaceuticals Inc.
(858) 376-2637
aengbring@conatuspharma.com