Late-Breaker Posters on Results From Emricasan Phase 2 NAFLD/NASH and ACLF Clinical Trials
Poster on Safety and Activity Results From Emricasan Phase 1 Organ Impairment Clinical Trials
SAN DIEGO, CA, USA I April 23, 2015 I Conatus Pharmaceuticals Inc. (CNAT) announced today that posters providing detailed results from four recently completed clinical trials of emricasan, the company’s first-in-class, orally active pan-caspase protease inhibitor, are being presented this week at The International Liver Congress(TM) 2015, the 50th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, April 22-26, 2015.
Results from the company’s Phase 2 double-blind, placebo-controlled clinical trial of emricasan in patients with acute-on-chronic liver failure (ACLF), and Phase 2 double-blind, placebo-controlled clinical trial of emricasan in patients with nonalcoholic fatty liver disease (NAFLD), including the subset of NAFLD patients with nonalcoholic steatohepatitis (NASH), are addressed in two late-breaker posters:
- Poster #LP35, entitled “A placebo-controlled, multicenter, double-blind, randomised, pharmacokinetic and pharmacodynamic trial of emricasan (IDN-6556) in subjects with acute-on-chronic liver failure (ACLF);” and
- Poster #LP37, entitled “A placebo-controlled, multicenter, double-blind, randomised trial of emricasan (IDN-6556) in subjects with non-alcoholic fatty liver disease (NAFLD) and raised transaminases.”
A third poster addresses results from the company’s Phase 1 trial in patients with mild, moderate and severe hepatic impairment and the company’s Phase 1 trial in patients with severe renal impairment:
- Poster #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.”
All three posters are available on the Events & Presentations page in the Investor Center of the Conatus website at www.conatuspharma.com.
Steven J. Mento, Ph.D., President and Chief Executive Officer of Conatus, said, “Emricasan has demonstrated the potential to address the full spectrum of liver disease across a broad range of etiologies and disease severity. Conatus is initially focusing on the treatment of cirrhosis, particularly NASH-driven cirrhosis. The results from our clinical development activities in 2014 are paving the way for our emricasan registration strategy. Our ACLF and organ impairment trials defined safe and effective dosing of emricasan in patients with cirrhosis, including those with liver function impairment. Our NAFLD/NASH trial confirmed that the optimal dose of emricasan is consistent across different etiologies. With a comprehensive data package that includes the results we are presenting at the EASL meeting, we are now preparing to meet with regulatory authorities to seek specific guidance on the appropriate endpoints that could support regulatory approval, in particular surrogate endpoints that could be used in accelerated approval pathways.”
Conatus intends to include NASH-driven cirrhosis in its initial registration strategy for emricasan. This population already represents a high unmet medical need that is expected to continue growing in the years ahead. Importantly, three validated surrogate markers of mortality risk were identified for this segment of liver disease patients in a manuscript co-authored by the American Association for the Study of Liver Diseases (AASLD) and the U.S. Food and Drug Administration (FDA), and accepted in January 2015 for publication in the scientific journal Hepatology:
- Model for End-stage Liver Disease (MELD) score;
- Child-Pugh-Turcotte (CPT) score; and
- Hepatic venous pressure gradient (HVPG).
In May 2014, the company initiated a Phase 2 clinical trial in post-orthotopic liver transplant (POLT) recipients with 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). Consistent with our focus on cirrhosis, the company has recently expanded the inclusion criteria in this trial to allow enrollment of patients with cirrhosis. Subjects will receive 25 mg of emricasan orally twice daily for two years. The trial is evaluating long-term safety and biopsy-based changes in fibrosis and cirrhosis. Pre-treatment baseline data from the initial group of subjects in this trial are expected to be available in the second quarter of 2015.
In September 2014, the company initiated an exploratory, open-label Phase 2 clinical trial in subjects with liver cirrhosis of mixed etiologies and portal hypertension confirmed by HVPG procedure prior to enrollment. Subjects will receive 25 mg of emricasan orally twice daily for 28 days. The co-primary endpoints are the changes from baseline in HVPG and cleaved Cytokeratin-18 (cCK18), a mechanism-specific biomarker that increases with liver disease severity. Secondary endpoints include the changes from baseline in MELD score and CPT score. Top-line results from this trial are expected to be available in the third quarter of 2015.
Also in September 2014, the company initiated a double-blind, placebo-controlled Phase 2 clinical trial in subjects with liver cirrhosis of mixed etiologies, mild to moderate liver impairment and a MELD score of 11 to 18 during the screening period. In the first stage, which is double-blind and placebo-controlled, subjects will be randomized 1:1 to receive either 25 mg of emricasan or placebo orally twice daily for three months. The primary endpoint is change from baseline in cCK18. Secondary endpoints include change from baseline in MELD score and change from baseline in CPT score. In the second stage, which will be open-label, subjects who complete the first stage of the trial, either on treatment or placebo, may receive emricasan for up to an additional three months. Initial results from the first stage of this trial are expected to be available in the fourth quarter of 2015.
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.
SOURCE: Conatus Pharmaceuticals
Post Views: 79
Late-Breaker Posters on Results From Emricasan Phase 2 NAFLD/NASH and ACLF Clinical Trials
Poster on Safety and Activity Results From Emricasan Phase 1 Organ Impairment Clinical Trials
SAN DIEGO, CA, USA I April 23, 2015 I Conatus Pharmaceuticals Inc. (CNAT) announced today that posters providing detailed results from four recently completed clinical trials of emricasan, the company’s first-in-class, orally active pan-caspase protease inhibitor, are being presented this week at The International Liver Congress(TM) 2015, the 50th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, April 22-26, 2015.
Results from the company’s Phase 2 double-blind, placebo-controlled clinical trial of emricasan in patients with acute-on-chronic liver failure (ACLF), and Phase 2 double-blind, placebo-controlled clinical trial of emricasan in patients with nonalcoholic fatty liver disease (NAFLD), including the subset of NAFLD patients with nonalcoholic steatohepatitis (NASH), are addressed in two late-breaker posters:
- Poster #LP35, entitled “A placebo-controlled, multicenter, double-blind, randomised, pharmacokinetic and pharmacodynamic trial of emricasan (IDN-6556) in subjects with acute-on-chronic liver failure (ACLF);” and
- Poster #LP37, entitled “A placebo-controlled, multicenter, double-blind, randomised trial of emricasan (IDN-6556) in subjects with non-alcoholic fatty liver disease (NAFLD) and raised transaminases.”
A third poster addresses results from the company’s Phase 1 trial in patients with mild, moderate and severe hepatic impairment and the company’s Phase 1 trial in patients with severe renal impairment:
- Poster #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.”
All three posters are available on the Events & Presentations page in the Investor Center of the Conatus website at www.conatuspharma.com.
Steven J. Mento, Ph.D., President and Chief Executive Officer of Conatus, said, “Emricasan has demonstrated the potential to address the full spectrum of liver disease across a broad range of etiologies and disease severity. Conatus is initially focusing on the treatment of cirrhosis, particularly NASH-driven cirrhosis. The results from our clinical development activities in 2014 are paving the way for our emricasan registration strategy. Our ACLF and organ impairment trials defined safe and effective dosing of emricasan in patients with cirrhosis, including those with liver function impairment. Our NAFLD/NASH trial confirmed that the optimal dose of emricasan is consistent across different etiologies. With a comprehensive data package that includes the results we are presenting at the EASL meeting, we are now preparing to meet with regulatory authorities to seek specific guidance on the appropriate endpoints that could support regulatory approval, in particular surrogate endpoints that could be used in accelerated approval pathways.”
Conatus intends to include NASH-driven cirrhosis in its initial registration strategy for emricasan. This population already represents a high unmet medical need that is expected to continue growing in the years ahead. Importantly, three validated surrogate markers of mortality risk were identified for this segment of liver disease patients in a manuscript co-authored by the American Association for the Study of Liver Diseases (AASLD) and the U.S. Food and Drug Administration (FDA), and accepted in January 2015 for publication in the scientific journal Hepatology:
- Model for End-stage Liver Disease (MELD) score;
- Child-Pugh-Turcotte (CPT) score; and
- Hepatic venous pressure gradient (HVPG).
In May 2014, the company initiated a Phase 2 clinical trial in post-orthotopic liver transplant (POLT) recipients with 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). Consistent with our focus on cirrhosis, the company has recently expanded the inclusion criteria in this trial to allow enrollment of patients with cirrhosis. Subjects will receive 25 mg of emricasan orally twice daily for two years. The trial is evaluating long-term safety and biopsy-based changes in fibrosis and cirrhosis. Pre-treatment baseline data from the initial group of subjects in this trial are expected to be available in the second quarter of 2015.
In September 2014, the company initiated an exploratory, open-label Phase 2 clinical trial in subjects with liver cirrhosis of mixed etiologies and portal hypertension confirmed by HVPG procedure prior to enrollment. Subjects will receive 25 mg of emricasan orally twice daily for 28 days. The co-primary endpoints are the changes from baseline in HVPG and cleaved Cytokeratin-18 (cCK18), a mechanism-specific biomarker that increases with liver disease severity. Secondary endpoints include the changes from baseline in MELD score and CPT score. Top-line results from this trial are expected to be available in the third quarter of 2015.
Also in September 2014, the company initiated a double-blind, placebo-controlled Phase 2 clinical trial in subjects with liver cirrhosis of mixed etiologies, mild to moderate liver impairment and a MELD score of 11 to 18 during the screening period. In the first stage, which is double-blind and placebo-controlled, subjects will be randomized 1:1 to receive either 25 mg of emricasan or placebo orally twice daily for three months. The primary endpoint is change from baseline in cCK18. Secondary endpoints include change from baseline in MELD score and change from baseline in CPT score. In the second stage, which will be open-label, subjects who complete the first stage of the trial, either on treatment or placebo, may receive emricasan for up to an additional three months. Initial results from the first stage of this trial are expected to be available in the fourth quarter of 2015.
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.
SOURCE: Conatus Pharmaceuticals
Post Views: 79
