Latest news
Enrollment completed for our Phase 2 clinical trial in Alport syndrome
ENYO Pharma is very proud to announce the successful completion of patient enrollment in ALPESTRIA-1, our Phase 2 clinical trial evaluating Vonafexor in Alport syndrome across the U.S. and Europe.
This major milestone was achieved with the last-patient-in dosed ahead of schedule. The study timelines were accelerated thanks to a tailored strategy based on a very strong and effective collaboration with our partners Natera and Accelsiors, all clinical sites in the US, France ans Spain with investigators,
The first patient dosed in the Phase 2 ALPESTRIA-1 clinical study of Vonafexor for Alport syndrome
The first patient with Alport Syndrome received their first oral doses of Vonafexor last month in the US as part of our Phase 2 ALPESTRIA-1 clinical study.
ALPESTRIA-1 evaluates the safety and the effects of Vonafexor on kidney function in subjects with at risk of progression Alport syndrome. The total duration of study for a participant will be up to 40 weeks and include a screening period, a treatment period of 24 weeks and a follow-up period of 12 weeks.
The Phase 2 ALPESTRIA-1 clinical study has started with Vonafexor on Alport syndrome
The ALPESTRIA-1 Phase 2 clinical study (NCT06425055) is an open-label, single arm, fixed dose escalation of the investigational drug Vonafexor. This study is a proof-of-concept trial of Vonafexor safety, its effects on kidney function in subjects with at risk of progression Alport syndrome. The study aims to recruit 20 patients in the US and EU (France, Spain and Germany).
The first site for patient recruitment is now open in Idaho (US) and more sites will open in the coming weeks.
Orphan Drug Designation (ODD) granted to Vonafexor for Alport syndrome by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA)
ENYO Pharma announces that both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation (ODD) to Vonafexor, our fibrolytic & anti-inflammatory clinical compound, for the treatment of Alport syndrome.
Alport syndrome is a rare kidney disease, a genetic disorder affecting 1 in 5,000-10,000 live births. It is characterized by a progressive loss of kidney function and may result in hearing loss and eye abnormalities.
New publication: Hepatic and renal improvements with FXR agonist Vonafexor in individuals with suspected fibrotic NASH
ENYO Pharma is proud to share the publication of the results from our Phase 2 LIVIFY study with Vonafexor in NASH patients in Journal of Hepatology.
This article describes the remarkable effects of Vonafexor after only 12 weeks of treatment in these patients: strong liver fat reduction, weight loss, liver enzyme improvements …., and last but not least renal function recovery. These strongly differentiated fibrolytic and anti-inflammatory effects of Vonafexor compared to other FXR agonists correlate very well with those observed in several preclinical models of severe CKD and rare kidney diseases like Alport Syndrome.
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