Leveraging Orphan Drug Designation in Clinical Trial for Liver Transplant Recipients
SAN FRANCISCO – (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 plans to initiate a placebo-controlled (open to sponsor) Phase 2b clinical trial in the second half of 2014 evaluating its lead drug candidate emricasan in Post Orthotopic Liver Transplant (POLT) recipients. 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. The trial will focus on the subset of POLT patients with reestablished liver fibrosis as a result of recurrent post-transplant hepatitis C virus infection who have successfully achieved a sustained viral response following HCV antiviral therapy (HCV-POLT).
“The recent grant of Orphan Drug Designation establishes POLT as our best near-term opportunity to demonstrate proof of concept for emricasan as an anti-fibrosis agent,” said Conatus Co-founder, President and Chief Executive Officer, Steven J. Mento, Ph.D., “and the well characterized and closely monitored HCV-POLT patient population is most appropriate for clinical evaluation. New antiviral drugs have the potential to clear HCV infection in this patient population, but do not necessarily prevent reestablished liver fibrosis from advancing to cirrhosis and ultimate failure of the newly transplanted organ. In the planned trial, which includes ongoing interim analyses, we have the opportunity to explore the potential for advancement along an accelerated regulatory pathway in this indication and confirm the scientific rationale to expand into broader indications.
“This new trial rounds out our clinical development program for 2014,” added Dr. Mento, “with key anticipated milestones this year including:
Acute-on-chronic liver failure (ACLF) Phase 2b trial results expected in the first half of 2014;
Non-alcoholic steatohepatitis (NASH) Phase 2 trial to initiate in the first half of 2014;
Chronic liver failure (CLF) Phase 2b trial to initiate in the second half of 2014; and
HCV-POLT Phase 2b trial to initiate in the second half of 2014.”
Conatus will be meeting with members of the investment community in San Francisco this week. A copy of the presentation being used in these meetings is available in the Investor Center of the Conatus website at www.conatuspharma.com.
About Emricasan Clinical Development
Conatus is developing emricasan for the treatment of patients with chronic liver disease and acute exacerbations of chronic liver disease. To date, emricasan has been studied in over 500 subjects in ten clinical trials. In a randomized 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 all the 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 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 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 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 anticipated timing of clinical trials of emricasan in ACLF, CLF, NASH and HCV-POLT 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; 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.