On Dec 27, we issued an updated research report on Conatus Pharmaceuticals Inc. CNAT. This San Diego-based company has no approved product in its portfolio at the moment and focuses on developing its lead pipeline candidate, emricasan.
Emricasan, a caspase inhibitor, is being developed for the treatment of patients with fibrosis or cirrhosis caused by nonalcoholic steatohepatitis (NASH). Conatus acquired the worldwide rights to emricasan from Pfizer PFE in July 2010. It has an exclusive option, collaboration and license agreement with Novartis NVS for the worldwide development and commercialization of emricasan.
Conatus is conducting three ongoing phase IIb ENCORE studies on emricasan for treating fibrosis or cirrhosis induced by NASH. The programs are, namely ENCORE-NF (for NASH fibrosis), ENCORE-PH (for portal hypertension) and ENCORE-LF (for liver function).
Earlier this month, Conatus announced top-line results from phase IIb ENCORE-PH study, which evaluated emricasan in patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension. The study examined the capacity of emricasan to reduce hepatic venous pressure gradient (HVPG) in NASH cirrhosis patients. Although emricasan demonstrated clinically meaningful treatment effects in compensated NASH cirrhosis patients, who stand at a risk of passing to the decompensation state, it failed to meet the primary endpoint.
The ENCORE-NF assessment is investigating emricasan for potential improvements in fibrosis and steatohepatitis pertaining to patients with fibrosis caused by NASH. Top-line data from the study is expected in the first half of 2019.
The ENCORE-LF study is inspecting emricasan in patients with decompensated NASH cirrhosis. Notably, top-line results from the study will be presented in mid-2019, much earlier than the previously estimated timeline of the second half of 2019.
Notably, the NASH market holds untapped prospects. People afflicted with diabetes, high cholesterol or high triglycerides are often diagnosed with the disease, which is feared to become the fastest-growing cause for liver transplant and liver cancer. With no treatments currently available for this indication, the market opportunity for emricasan seems significant. By 2025, the worldwide market for NASH treatments is estimated to reach a value of $35 billion.
Given such an upbeat scenario, we believe that emricasan has the power to capture a large market share on approval.
Apart from emricasan, another candidate in Conatus’ portfolio is IDN-7314, which is currently being evaluated in a phase II study for the treatment of primary sclerosing cholangitis (PSC), a chronic liver disease. Notably, the candidate enjoys an Orphan Drug Designation (ODD) for the indication in both the United States and across the EU.
So far this year, shares of Conatus have plummeted 72.1%, significantly wider than the industry’s decrease of 7.4%.