- Emricasan Safety and Activity Observations and Conclusions from Hepatic Impairment Clinical Trial -
- Late-breakers on Detailed Results from NAFLD/NASH and ACLF Clinical Trials -
SAN DIEGO, April 8, 2015 (GLOBE NEWSWIRE) -- Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) announced today that three posters addressing clinical results with emricasan, the company's first-in-class, orally active pan-caspase protease inhibitor, have been accepted for presentation at The International Liver Congress™ 2015, the 50th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, April 22-26, 2015.
An abstract accepted under the standard submission deadline for a poster (ePoster #P0396) entitled, "Emricasan, a potent pan-caspase inhibitor, rapidly reduces caspase activity and biomarkers of apoptosis in patients with hepatic impairment but not in healthy volunteers: implications for safety, selectivity and mechanism of action," was published today on the EASL website at https://ilc-congress.eu/scientific-info/abstracts/. This poster will be presented on April 24 at 3:30 p.m. CET at ePoster screen A-02.
"In multiple clinical trials, emricasan has consistently and rapidly reduced circulating elevated levels of caspase activity and markers of apoptosis in subjects with liver disease," said Al Spada, Executive Vice President of Research and Development and Chief Scientific Officer of Conatus. "In contrast, emricasan has no discernable effect on circulating levels of caspase activity or markers of apoptosis in healthy individuals. This important observation provides new insight on the safety and selectivity of emricasan and further supports our belief that emricasan is uniquely suited to potentially address multiple patient populations across the spectrum of liver disease."
Two abstracts were accepted for late-breaker posters. One abstract details results from the company's Phase 2 double-blind, placebo-controlled clinical trial of emricasan in 38 patients with nonalcoholic fatty liver disease (NAFLD), including the subset of NAFLD patients with nonalcoholic steatohepatitis (NASH). Top-line results from the NAFLD/NASH trial were reported in March. The other abstract details results from the company's Phase 2 double-blind, placebo-controlled clinical trial of emricasan in 21 patients with acute-on-chronic liver failure (ACLF). Top-line results from the ACLF trial were reported in January. The late-breaker abstracts will remain under embargo until the EASL meeting date.
Summary of Hepatic Impairment Abstract
Emricasan was administered as a single 50 mg oral dose to patients with mild (n=8), moderate (n=12) or severe (n=8), hepatic impairment and 8 matched healthy controls. In a separate trial, emricasan was administered as a single 50 mg dose to 8 subjects with severe renal impairment and 8 matched healthy controls. In both trials, serial blood samples were collected over a 48-hour period and analyzed for markers of apoptosis, cell death and caspase enzymatic activity.
All 28 subjects with hepatic impairment experienced rapid and significant reductions (p<0.05), relative to Baseline for all of these markers of mechanistic activity and pharmacodynamic response following a single 50 mg oral dose of emricasan. In subjects with severe renal impairment, markers of cell death and caspase activity were elevated at Baseline relative to controls and emricasan had no effect on these markers. Emricasan also had no effect on caspase activity or markers of apoptosis in healthy volunteers.
Conclusions from these observations included that:
- In healthy individuals, normal caspase activity and apoptosis are largely unaffected by emricasan;
- The lack of effect in subjects with severe renal impairment suggests a high degree of liver tissue specificity for emricasan; and
- Emricasan may provide clinical benefit to patients with liver disease including those with advanced stages of liver disease.
About Emricasan Clinical Development
To date, emricasan has been studied in over 550 subjects in fourteen 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 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.
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 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 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: emricasan's ability to address multiple patient populations across the spectrum of liver disease, a high degree of liver tissue specificity for emricasan; potential clinical benefit of emricasan in patients with liver disease including those with advanced stages of liver disease; and the potential of emricasan 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: dosing of emricasan beyond a single dose, the effect on liver disease by decreasing the biomarkers, Conatus' ability to initiate and successfully complete current and future clinical trials; Conatus' dependence on its ability to obtain regulatory approval for, and then successfully commercialize emricasan, which is Conatus' only drug candidate; Conatus' reliance on third parties to conduct its clinical trials, enroll subjects, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of emricasan, if approved; the potential that earlier clinical trials may not be predictive of future results; 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 potential for competing products to limit the clinical trial enrollment opportunities for emricasan in certain indications; the uncertainty of the U.S. Food and Drug Administration's and other regulatory agencies' approval processes and other regulatory requirements; Conatus' ability to fully comply with numerous federal, state and local laws and regulatory requirements applicable to it; Conatus' limited operating history and its ability to operate successfully as a public company; 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.