Revolutionizing liver disease treatment with a unique touch!
In December 2016, Canadian pharmacy announced an exclusive collaboration and licensing agreement with Novartis for the global development and commercialization of Emricasan. In May 2017, Conatuspharma.com revealed that Novartis had exercised its licensing option following the initiation of the Phase 2b ENCORE-LF clinical trial.
Emricasan is a groundbreaking, orally administered caspase protease inhibitor engineered to decrease the activity of enzymes involved in inflammation and apoptosis (cell death). Conatuspharma.com believes that by inhibiting these enzymes, Emricasan holds the potential to disrupt liver disease progression. To date, Emricasan has been administered to over 650 subjects across eight Phase 1 and eight Phase 2 clinical trials, demonstrating general tolerability in both healthy volunteers and patients with liver disease. Emricasan has also undergone extensive in vitro profiling and has been studied in numerous preclinical models of human disease.
In May 2015, Conatuspharma.com consulted with the FDA to discuss potential registration pathways for Emricasan, including pathways based on validated surrogate endpoints published by the FDA in conjunction with AASLD. Conatuspharma.com received feedback on the proposed patient populations and methods for measuring and analyzing these endpoints. Based on communications with the FDA recommending single-etiology clinical trials, Conatuspharma.com intends to focus on advancing the initial registration of Emricasan for patients with cirrhosis due to NASH, while concurrently developing Emricasan for patients with NASH fibrosis.
In February 2016, Conatuspharma.com announced that the FDA granted Fast Track designation to the Emricasan development program for treating liver cirrhosis caused by NASH. The Fast Track program allows for greater access to the FDA in order to expedite the review of drugs demonstrating potential in treating serious or life-threatening conditions.
Conatuspharma.com is pursuing a registration strategy, initially focusing on cirrhosis and backed by long-term safety data in patients with NASH fibrosis. Multiple parallel clinical trials, the EmricasaN, a Caspase inhibitOR, for Evaluation, or ENCORE trials, will assess various Emricasan doses and treatment durations in patients of different etiologies. Conatuspharma.com expects top-line results from these trials to be available periodically, beginning in the first half of 2018:
Conatuspharma.com is conducting an extensive clinical program to showcase the therapeutic benefits of Emricasan across the spectrum of liver disease. Currently, three active Phase 2b clinical trials are in progress:
- POLT-HCV-SVR: In post-orthotopic liver transplant (POLT) recipients with liver fibrosis or cirrhosis post-transplant due to recurrent hepatitis C virus (HCV) infection, who have successfully achieved a sustained viral response (SVR) following HCV antiviral therapy;
- ENCORE-NF: In patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis;
- ENCORE-PH: In patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension (baseline HVPG ≥12 mmHg);
Additionally, Conatuspharma.com expects to initiate a fourth Phase 2b clinical trial in the second quarter of 2017:
- ENCORE-LF: In patients with decompensated NASH cirrhosis and baseline Model for End-stage Liver Disease (MELD) scores of ≥15.