Vonafexor, a liver disease drug by Enyo Pharma, during a mid-stage clinical trial, showed exceptional results in reducing liver fat ultimately boosting kidney health. It supported the next-stage pivotal studies while achieving its primary and secondary goals.
The drug, also known as EYP001, is being tested for the patients having Non-alcoholic Steato-Hepatitis (NASH). NASH is a liver disease causing fat accumulation leading to liver damage or even failure.
96 patients were given either vonafexor or placebo in the phase 2a trial, called Livify. In more than half (58%) of the patients from vonafexor group, the drug reduced liver fat by 5% or even more than that, in contrast to the 22% from the other group. The drug also reduced other biomarkers leading to the organ damage and significantly improved kidney health. On the other hand, patients on placebo experienced kidney health deterioration.
The company said that the drug can increase metabolism rate by reducing body weight, waist size and waist-to-height ratio, hence playing a facilitating role in mitigating risks associated with cardio-vascular morbidity.
NASH is a highly demanded indication as numerous large scale as well as small scale companies are trying to dominate the market. Unfortunately, many of them have not been successful during their clinical trials including Genfit and NGM Biopharmaceuticals. Any company following the success could fetch billions of dollars through yearly sales as predicted by some analysts.
No such data, regarding adverse effects in the trials, has been provided by Enyo, other than itchiness, that persists in clinical trials of all NASH drugs of this class. However, the reported cases were, by and large, mild, with even less than 10% of patients being dropped out, according to the company.
Enyo Pharma is now planning to test the drug in conjunction with other treatments “to maximize the benefit of such treatments for NASH patients,” which is supported by other biopharmas. Supplementary outcomes of the study will be released further at the future medical meetings. Enyo Pharma raised €40 million ($46.9 million) in June 2018 series B round to support its clinical trials. The raised funds aided two clinical trials of vonafexor; one for Hepatitis B and the other one for NASH.
