In a major scientific breakthrough for Conatus Pharmaceuticals Inc (NASDAQ:CNAT), the Emricasan drug of the company has got the fast track designation by the U.S. Food and Drug Administration (FDA). Emricasan is a program for treating liver cirrhosis patients who get the disease through nonalcoholic steatohepatitis (NASH).
Now, the clinical trials for patients suffering from NASH cirrhosis and NASH fibrosis are going to be initiated by the company. Conatus Pharmaceuticals is now mulling advancement in the Emricasan development program through registration of patients for initiation of the clinical studies to support their findings so far.
Successful Portal Hypertension Trial
According to Steven J. Mento, Co-founder, President and Chief Executive Officer of the company, the FDA nod has come after successful completion of the Portal Hypertension trial. The trial showed a drop in the hepatic venous pressure gradient (HVPG) in portal hypertension patients after taking the emricasan treatment for just 30 days. He said that the Fast Track designation was an excellent opportunity for the drug to treat severe life-threatening ailments and NASH patients would get a vital recovery treatment once the trials yielded success.
Emricasan has been researched through sixteen lab tests till now for multiple liver diseases at different stages. Inflammation and apoptosis symptoms that are common with most liver diseases have seen a significant reduction in most of the trials conducted by the company. Liver cirrhosis patients at an advanced level of the disease have also benefitted from use of the drug in the most recent trial.
Clinical Trials Underway
The company had unveiled the plans of conducting Evaluation (ENCORE) clinical trials for different emricasan doses in chronic liver disease patients in November 2015. These trials will help ascertain the dose required to treat different liver ailments across patients at various stages.
The Phase 2b ENCORE-NF clinical trial that is underway is going to evaluate the long-term benefits of the drug in treating liver ailments caused by NASH. Patients having undergone the post-orthotopic liver transplant (POLT) who got diagnosed with the disease due to hepatitis C virus (HCV) are also been analyzed for evaluating the effects that the drug has.