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February 13, 2016 6:58 AM ET

Biotechnology

Company Overview of Conatus Pharmaceuticals Inc.

Company Overview

Conatus Pharmaceuticals Inc., a biotechnology company, focuses on the development and commercialization of novel medicines to treat liver diseases in the United States. Its products include Emricasan, an orally active pan-caspase protease inhibitor, which is in Phase 2 clinical trials for the treatment of liver cirrhosis, acute-on-chronic liver failure, post liver transplant clearance of hepatitis C virus infection with sustained viral response, non-alcoholic steatohepatitis, and nonalcoholic fatty liver disease. The company was founded in 2005 and is headquartered in San Diego, California.

16745 West Bernardo Drive

Suite 200

San Diego, CA 92121

United States

Founded in 2005

25 Employees

Phone:

858-376-2600

Key Executives for Conatus Pharmaceuticals Inc.

Co-Founder, Chief Executive Officer, President and Director
Age: 63
Total Annual Compensation: $460.0K
Co-Founder, Chief Scientific Officer and Executive Vice President of Research & Development
Age: 57
Total Annual Compensation: $325.6K
Executive Vice President of Clinical Development
Age: 60
Total Annual Compensation: $94.0K
Compensation as of Fiscal Year 2014.

Conatus Pharmaceuticals Inc. Key Developments

U.S. Food and Drug Administration Grants Conatus Fast Track Designation for Development of Emricasan in Nash Cirrhosis

Conatus Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s emricasan development program for the treatment of liver cirrhosis caused by nonalcoholic steatohepatitis (NASH). Based on additional communications with the FDA recommending single-etiology clinical trials, the company plans to focus on advancing toward initial registration of emricasan for patients with NASH cirrhosis, with parallel development toward registration of emricasan for patients with NASH fibrosis, and supportive clinical trials addressing additional patient populations. The Fast Track program provides for greater access to FDA to facilitate development and expedite review of drugs that have demonstrated the potential to treat serious or life-threatening conditions. The data from recently completed Portal Hypertension trial, showing clinically meaningful reductions in hepatic venous pressure gradient (HVPG) in patients with severe portal hypertension after only one month of treatment with emricasan, were a key component of Fast Track submission.

Conatus Pharmaceuticals Inc. Initiates Phase 2b ENCORE-NF Clinical Trial of Emricasan in Patients With NASH Fibrosis

Conatus Pharmaceuticals Inc. announced the initiation of active patient recruitment in ENCORE-NF, a randomized, double-blind, placebo-controlled, Phase 2b clinical trial evaluating emricasan, the company’s first-in-class, orally-active pan-caspase inhibitor, in approximately 330 patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) and stage 1 to 3 fibrosis using the NASH Clinical Research Network (CRN) Histologic Scoring System. This trial is designed to evaluate differentiated dosing and establish efficacy of emricasan in the large and growing NASH fibrosis market as well as add long-term safety data in support of the company’s initial registration focus in liver cirrhosis. The ENCORE-NF clinical trial is expected to be conducted at approximately 90 U.S. and EU clinical sites. Patients will be randomized 1:1:1 to receive 5 mg of emricasan, 50 mg of emricasan, or placebo twice daily for 72 weeks. The 5 mg and 50 mg doses have previously been shown to be equally effective in reducing ALT, AST and mechanism-specific biomarkers in patients with liver fibrosis, while the 50 mg dose may provide additional benefit in patients with liver cirrhosis. The primary endpoint is a biopsy-based improvement in fibrosis by at least one stage vs. placebo using NASH CRN without worsening of steatohepatitis. Secondary endpoints include resolution of steatohepatitis without worsening of fibrosis, nonalcoholic fatty liver disease (NAFLD) activity score (NAS) and its components (steatosis, lobular inflammation, and ballooning), collagen and fat content by biopsy, key serum biomarkers, and health-related quality of life, as well as safety and tolerability of emricasan. Top-line results from the ENCORE-NF clinical trial are expected in 2018. The ENCORE-NF clinical trial is the first of multiple parallel EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) Phase 2b clinical trials designed to evaluate multiple doses of emricasan over various treatment durations in chronic liver disease of different etiologies and disease stages. The ENCORE trials are designed to provide clinically relevant efficacy, dosing, and safety data to support the initial registration of emricasan for chronic administration in patients with liver cirrhosis. Results from the combined ENCORE clinical trials are expected to support the design of Phase 3 efficacy and safety trials, but could warrant earlier discussions with regulatory agencies regarding potential accelerated approval. Conatus expects to initiate the remainder of these trials on a staggered basis through early 2017 and expects top-line results from the ENCORE clinical trials to be available periodically beginning in the first half of 2018.

Conatus Pharmaceuticals Inc. Announces Positive Results of Phase 2 Liver Cirrhosis Clinical Trial

Conatus Pharmaceuticals Inc. announced that the three-month, double-blind, placebo-controlled stage of the company's multicenter Phase 2 Liver Cirrhosis clinical trial showed a statistically significant reduction in caspase-cleaved cytokeratin 18 (cCK18) vs. placebo (p=0.04) in the overall patient population when adjusted for differences between treatment and placebo groups in baseline Model for End-stage Liver Disease (MELD) score and disease etiology as specified in the trial statistical analysis plan. cCK18 is a mechanism-specific biomarker of caspase-driven cell death. Multiple additional liver disease biomarkers achieved statistically significant reductions vs. placebo in the overall patient population after three months of treatment, while others achieved positive trends. The company believes that the consistent pattern of improvement across these biomarkers in the overall patient population provides strong evidence of a favorable treatment effect with emricasan, the company's first-in-class, orally-active pan-caspase inhibitor. Additional analyses of the three-month data showed the following treatment effects in this subgroup: 1.6 reduction in mean MELD score with emricasan vs. 0.6 increase with placebo (p=0.003); Patients achieving at least 2-point reductions in MELD score; 6 of 9 with emricasan vs. 2 of 10 with placebo; Patients achieving reductions in MELD score to 14; 4 of 9 with emricasan vs. 1 of 10 with placebo; 0.6 reduction in mean Child-Pugh score with emricasan vs. 0.6 increase with placebo (p=0.003); Patients achieving at least 1-point changes in Child-Pugh score; 4 of 9 had decreases with emricasan vs. 2 of 10 with placebo; and 0 of 9 had increases with emricasan vs. 4 of 10 with placebo. The company plans to use the forthcoming six-month data from this clinical trial to understand whether longer dosing may also demonstrate a treatment effect as measured by MELD and Child Pugh in patients with lower baseline MELD scores and the overall patient population. The company expects that the upcoming six-month Liver Cirrhosis clinical trial data will allow the company to determine, with the continued engagement of the regulatory authorities, whether the ENCORE-LF clinical trial, originally planned as a Phase 2 clinical trial, may be redesigned to qualify as Phase 3. The company is advancing with its plans to initiate the ENCORE clinical trials on a staggered basis over the next year. The double-blind, placebo-controlled Phase 2 Liver Cirrhosis clinical trial was conducted at 26 U.S. sites and enrolled 86 patients with liver cirrhosis due to different etiologies, mild to moderate liver impairment and baseline MELD scores of 11 to 18. In the double-blind and placebo-controlled stage, patients were randomized 1:1 to receive either 25 mg of emricasan or placebo orally twice daily for three months. The primary endpoint was change from baseline in cCK18. Secondary endpoints included changes from baseline in MELD and Child-Pugh scores, which include laboratory parameters associated with liver synthetic and excretory function, such as serum albumin levels, international normalized ratio (INR) and total bilirubin levels. In the open-label stage, all patients either on emricasan or placebo receive emricasan for an additional three months. Six-month data from patients who continued treatment and three-month data from placebo patients who crossed over to emricasan treatment are expected in the second quarter of 2016. Among the 86 subjects enrolled and dosed, liver cirrhosis etiologies included alcohol (38%), hepatitis C virus (29%), non-alcoholic steatohepatitis (23%), and other causes (9%). Baseline MELD scores were 14 in 78% of enrolled subjects and 15 in 22% of enrolled subjects. Baseline Child-Pugh status was A (Child-Pugh score of 5-6) in 43% of subjects and B (Child-Pugh score of 7-9) in 56% of subjects.

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