Conatus Pharmaceuticals Extends Liver Disease Reach With Phase 2 NAFLD/NASH Trial
SAN DIEGO (GLOBE NEWSWIRE) -- Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced the initiation of a Phase 2 clinical trial of its lead drug candidate, emricasan, in patients with nonalcoholic fatty liver disease (NAFLD), including the subset of NAFLD patients with inflammatory and/or fibrotic nonalcoholic steatohepatitis (NASH).
"Compelling preclinical data in models of both NAFLD and NASH suggest therapeutic potential for emricasan," said Conatus Co-founder, President and Chief Executive Officer, Steven J. Mento, Ph.D., "and we believe that this trial is an important first step to evaluate that potential. Our goal for this trial is to expand our safety database into a broader patient population and to explore emricasan's potential activity in the NAFLD/NASH population. Clinical endpoints suitable to support approval of new treatments for NASH have not yet been fully defined, and we are appropriately engaged in the ongoing discussions."
The double-blind, placebo-controlled trial is designed to enroll approximately 40 patients at four planned U.S. clinical sites. Patients will be randomized 1:1 to receive either 25 mg of emricasan or placebo orally twice daily for 28 days and will then be followed for another 28 days. The primary endpoint in this exploratory proof-of-concept trial is a reduction of elevated levels of key biomarkers implicated in patients with NAFLD/NASH. The trial will also evaluate the safety and tolerability of emricasan in the target patient population. Top-line results are expected in the second half of 2014.
"We are pleased that we were able to accelerate initiation of our Phase 2 NAFLD/NASH trial," added Dr. Mento, "consistent with our strategy of positioning emricasan as a potential 'fast follower' to more advanced programs in the NASH indication. Our goal is to accumulate sufficient and relevant clinical data to allow rapid advancement of emricasan once appropriate regulatory pathways are defined."
About Emricasan Clinical Development
Conatus is developing emricasan for the treatment of patients with chronic liver disease and acute exacerbations of chronic liver disease, including acute-on-chronic liver failure (ACLF), chronic liver failure (CLF), NAFLD and NASH, as well as Post Orthotopic Liver Transplant (POLT) recipients with reestablished liver fibrosis as a result of recurrent post-transplant hepatitis C virus infection who have successfully achieved a sustained viral response (SVR) following HCV antiviral therapy (POLT-HCV-SVR). To date, emricasan has been studied in over 500 subjects in ten clinical trials. In a completed Phase 2b clinical trial, emricasan consistently demonstrated clinically meaningful, statistically significant, rapid and sustained reduction in elevated levels of two key biomarkers of inflammation and cell death 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 also supporting a pilot clinical study funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) in patients with severe alcoholic hepatitis.
About NAFLD and NASH
NAFLD occurs worldwide with a similar prevalence to obesity and type 2 diabetes. In the United States, it has emerged as the most common form of liver disease with population-based studies estimating a prevalence as high as 30% of the general population. In children aged 2-19 years, the prevalence is approximately 10%. NAFLD includes a spectrum of liver disease ranging from simple steatosis (fat deposition) to necrosis and inflammation characteristic of NASH. The prevalence of NASH in the United States is approximately 15% with even higher prevalence reported in diabetics (22%) and Hispanics (19%). Patients with NASH have an increased risk for disease progression to liver fibrosis (scarring) and irreversible liver damage (cirrhosis). Up to 50% of patients with NASH will develop progressive fibrosis over a 4-6 year period with up to 25% progressing to cirrhosis. NASH cirrhosis is now the third most common cause of liver transplantation in the United States. It is associated with an increased risk of hepatocellular carcinoma and mortality in patients awaiting liver transplant and can also recur post-transplant.
About Conatus Pharmaceuticals Inc.
Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. Conatus is developing emricasan as 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 progression 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, including statements regarding the therapeutic potential of emricasan and the timeline to start, complete and announce results of the Phase 2 NAFLD/NASH trial and the proposed activity of emricasan in patients with liver disease are forward-looking statements. 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: changes in the planned use of proceeds from Conatus' initial public offering; Conatus' ability to maintain sufficient capital to advance the clinical development of emricasan and fund Conatus' operations; Conatus' reliance on third parties to conduct its clinical trials, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of emricasan, if approved; potential adverse side effects or other safety risks associated with emricasan; results of current and future clinical trials of emricasan; the uncertainty of the FDA approval process and other regulatory requirements; uncertainty regarding defining clinical endpoints suitable to support approval of new treatments for NASH; the potential for competing products to limit the clinical trial enrollment opportunities for emricasan in certain indications; and those described in Conatus' prior press releases and 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.