VONAFEXOR (EYP001)

ENYO Pharma Announces 16 Weeks Vonafexor (EYP001) Top-Line Interim Results from Two on-going Phase 2a Studies in Chronic Hepatitis B Patients

Retrieved on: 
Friday, July 30, 2021
Infectious diseases, Biotechnology, Pharmaceutical, Health, Medical specialties, Clinical medicine, Medicine, Hepatitis B virus, Viral structural proteins, Bristol-Myers Squibb, Cyclopentanes, Entecavir, Hepatotoxins, HBsAg, Hepatitis, HBeAg, Chronic Hepatitis B (CHB), Vonafexor (EYP001), ENYO Pharma, CHRONIC HEPATITIS B (CHB), VONAFEXOR (EYP001), ENYO PHARMA

Vonafexor met the primary endpoint of lowering HBsAg by an average of 1 log10, a key biomarker of viral activity in the liver, after 16 weeks of treatment.

Key Points: 
  • Vonafexor met the primary endpoint of lowering HBsAg by an average of 1 log10, a key biomarker of viral activity in the liver, after 16 weeks of treatment.
  • These results in CHB patients are further positive news for Vonafexor, after the recent disclosure of strong positive clinical results in Non-Alcoholic Steato-Hepatitis (NASH) patients on July 28, 2021.
  • The subjects were thereafter maintained for the next 24 weeks on oral, once-daily 0.5 mg Entecavir only.
  • Established data on CHB patients confirm that more and more patients are HBeAg negative (>80% currently) as a consequence of the chronic evolution of their disease.

ENYO Pharma Announces Positive Vonafexor (EYP001) Results for the LIVIFY Phase 2a Study in F2-F3 NASH Patients over 12 weeks

Retrieved on: 
Wednesday, July 28, 2021
Pharmaceutical, Health, Clinical trials, Other Health, Branches of biology, Chemistry, Chemical compounds, Magnesium, Magnesium in biology, Physiology, Plant physiology, Orphan drugs, Gemigliptin, Upadacitinib, Non-Alcoholic Steato-Hepatitis (NASH), Vonafexor (EYP001), ENYO Pharma, NON-ALCOHOLIC STEATO-HEPATITIS (NASH), VONAFEXOR (EYP001), ENYO PHARMA

In this Phase 2a trial, 96 patients with NASH were randomized 1:1:1 to receive oral, once-daily Vonafexor at 200 mg or 100 mg, or placebo.

Key Points: 
  • In this Phase 2a trial, 96 patients with NASH were randomized 1:1:1 to receive oral, once-daily Vonafexor at 200 mg or 100 mg, or placebo.
  • There were no significant differences in efficacy endpoints between the 100 mg and the 200 mg Vonafexor treatment groups.
  • 76 % of the patients receiving Vonafexor had improved kidney function as measured by eGFR over 12 weeks while 66 % of patients receiving placebo had deterioration of kidney function over the 12 week study period1).
  • The positive results seen on several key non-invasive tests at 12 weeks of dosing are highly encouraging and support advancement of this compound forward in NASH.