SAN DIEGO, Oct. 8, 2014 (GLOBE NEWSWIRE) -- Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced that its late-breaking abstract was accepted for a poster presentation at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, November 7-11, 2014. The poster, entitled “Rapid and statistically significant reduction of markers of apoptosis and cell death in subjects with mild, moderate and severe hepatic impairment treated with a single dose of the pan-caspase inhibitor, emricasan,” will be presented on Monday, November 10, 2014. The abstract is available at www.aasld.org/.
In the abstract, Conatus disclosed that its lead drug candidate, the orally active pan-caspase protease inhibitor emricasan, reduced key biomarkers in a recently completed, single-dose, pharmacokinetic (PK)/pharmacodynamic (PD) Phase 1 clinical trial in subjects with mild, moderate or severe hepatic impairment (defined using the Child-Pugh criteria). Emricasan was administered to 28 subjects with hepatic impairment and 8 matched control subjects, and serial blood samples were collected over a 48 hour period. Levels of three key biomarkers of apoptosis (caspase-cleaved cytokeratin 18), cell death (full-length cytokeratin 18), and caspase enzymatic activity (caspase 3/7) were elevated at study baseline correlating to disease severity, and demonstrated rapid and statistically significant reductions after a single 50 mg oral dose of emricasan in all hepatic impairment subjects.
“We are encouraged by emricasan’s ability to reduce key disease-elevated biomarkers of caspase activity, apoptosis and cell death rapidly after even a single dose,” said Conatus President and Chief Executive Officer, Steven J. Mento, Ph.D. “Our ongoing Phase 2 trials in patients across a broad spectrum of liver disease are designed to assess whether reductions of these potential drivers of liver disease progression result in corresponding clinical benefit.”
The company is conducting three clinical trials investigating the PK and PD activity of emricasan in patients with impaired organ function to support dose selection and prioritization for advancement in its overall clinical development program: the Phase 1 clinical trial in patients with various degrees of hepatic impairment described above; a Phase 1 clinical trial in patients with severe renal impairment; and a Phase 2b clinical trial in patients with acute-on-chronic liver failure (ACLF) who may have simultaneous impairment of both liver and kidney function as well as other organ involvement. Preliminary PK data from the Phase 1 hepatic impairment trial and Phase 1 severe renal impairment trial were sufficient to identify the appropriate patients for inclusion in a recently initiated Phase 2 clinical trial in patients with liver cirrhosis. Since patients with variable degrees of liver and kidney function are expected to be assessed in future clinical trials, final PK data from all three of the above clinical trials will be evaluated in the aggregate after completion of the ACLF trial, and are expected to inform on optimal dosing of emricasan in future studies in potential target patient populations.
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 ACLF, liver cirrhosis (LC), portal hypertension (PH), 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), and nonalcoholic fatty liver disease (NAFLD), including patients with inflammatory and/or fibrotic nonalcoholic steatohepatitis (NASH). 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. To date, emricasan has been studied in over 550 subjects in twelve clinical trials.
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 pan-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.
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 significance of secondary PD endpoints and the measured biomarkers in relation to liver disease severity and treatment effect, the significance and timeframe of the reduction in biomarkers after treatment with emricasan, the correlation of biomarkers with liver disease severity, emricasan’s potential to impact on the biomarkers and the progression of liver disease, the ability to support dose selection and prioritize clinical development from the PK data, the potential for the PK data to inform on optimal dosing of emricasan in future studies in potential target patient populations, and emricasan’s potential to provide clinical benefit to patients across a broad 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: dosing of emricasan beyond a single dose, the applicability of the biomarkers as potential drivers of liver disease progression, the effect on liver disease by decreasing the biomarkers, the determination of the most appropriate patients for enrollment in the company’s Phase 2 clinical trial in patients with cirrhosis, the potential for competing products to limit the clinical trial enrollment in the company’s Phase 2 clinical trials, the company’s ability to successfully enroll patients in and complete its Phase 2 clinical trials; the company’s 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; the company’s ability to obtain additional financing in order to complete the development and commercialization of emricasan; and those risks described in the company’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. The events and circumstances reflected in the company’s 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, the company 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.
CONTACT: INVESTORS Alan Engbring, Conatus Pharmaceuticals (858) 376-2637, aengbring@conatuspharma.com MEDIA Mariesa Kemble, Sam Brown Inc. (608) 850-4745, mariesakemble@sambrown.com
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