Conatus Pharmaceuticals Initiates Phase 2b Trial Targeting Fibrosis in Liver Transplant Recipients
SAN DIEGO, May 12, 2014 (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 2b clinical trial of its lead drug candidate, emricasan, in post-orthotopic liver transplant (POLT) recipients with reestablished 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).
The placebo-controlled, double-blind (open to sponsor) trial is designed to enroll approximately 60 patients at approximately 15 planned U.S. clinical sites. Enrollment is expected to take approximately 12 months. Patients will be randomized 2:1 to receive either 25 mg of emricasan or placebo orally twice daily for 24 months and will then be followed for another month post-treatment. The primary endpoint in this exploratory proof-of-concept trial is the change in the Ishak Fibrosis Score compared with placebo. The trial will also evaluate histological markers of inflammation, key serum biomarkers, and the safety and tolerability of emricasan in the target patient population. The sponsor-open design may allow for interim data analyses and periodic disclosures on trial progress.
"The recent introduction of highly successful antiviral treatments has provided new hope for patients infected with HCV," said Conatus President and Chief Executive Officer, Steven J. Mento, Ph.D., "but clearance of the virus does not eliminate the damage already established in the liver. We believe emricasan may have the potential to accelerate the liver healing process, and this trial is designed to evaluate emricasan's potential impact on fibrosis. Proof of concept in this patient population could support expansion into additional liver fibrosis indications resulting from viral infections, obesity, chronic excessive alcohol use or autoimmune diseases."
The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to emricasan in late 2013 for the treatment of liver transplant recipients with reestablished fibrosis to delay the progression to cirrhosis and end-stage liver disease.
Patients with HCV who receive liver transplants as a result of HCV infection are at risk of residual HCV still being present in the patient's blood, which can immediately infect the new liver. Many of these patients will experience accelerated development of fibrosis and progression to cirrhosis of the transplanted liver due to the recurrence of HCV. Even after successful treatment with drugs designed to clear the HCV infection, fibrotic changes in the liver may persist for many years. Only about 30% of non-transplant HCV patients with fibrosis and SVR show histological signs of fibrosis improvement two years after virus clearance. The HCV landscape is expected to continue to evolve dramatically over the next five to ten years with the introduction of interferon-free regimens with greater efficacy and tolerability over the current antiviral therapies.
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), nonalcoholic fatty liver disease (NAFLD), including the subset of NAFLD patients with inflammatory and/or fibrotic nonalcoholic steatohepatitis (NASH), as well as 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 reductions 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 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 and acute exacerbations of chronic liver disease. Emricasan is a first-in-class, orally active caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and cell death, or 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, including statements regarding the expected number of patients, trial sites and enrollment period for the trial, potential interim data analyses and periodic disclosures on trial progress, emricasan's potential to accelerate the liver healing process, potential expansion of emricasan into additional liver fibrosis indications, and emricasan's potential to interrupt the progression of 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: the potential for competing products to limit the clinical trial enrollment in the Phase 2b clinical trial, Conatus' ability to successfully enroll patients in and complete the Phase 2b clinical trial; Conatus' reliance on third parties to conduct its clinical trials, including the enrollment of patients, and manufacture its clinical drug supplies of emricasan; potential adverse side effects or other safety risks associated with emricasan that could delay or preclude its approval; results of future clinical trials of emricasan; 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.
Source: Conatus Pharmaceuticals
Posted: May 2014