Enyo Pharma ("Enyo") announced that its Investigational New Drug (IND) application has been approved by the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical study of vonafexor. It is a highly selective FXR agonist for Alport syndrome.
In addition, Enyo announced the closing of its first €39 million Series C equity financing, highlighting Enyo as an emerging biotech company in the kidney disease space. The funds raised will be used for the Phase 2 ALPESTRIA-1 study and to further analyze the efficacy of vonafexor** in other kidney diseases, such as autosomal dominant polycystic kidney disease (ADPKD). The round was co-led by Orbimed and Morningside Ventures, with participation from other existing investors, including Andera Partners, Bpifrance Innobio and Bpifrance Large Ventures.
The approval of the ENYO New Drug Application is a significant milestone for the company as it opens the company's first kidney disease-focused clinical trial. Enyo's lead drug candidate, Vonafexor, as well as the fast-track drug EYP651, are highly specific FXR agonists and are administered orally once daily. Both compounds have strong fibrolytic and anti-inflammatory properties and are widely used in a variety of kidney diseases. The effect of vonafexor on renal function (EGFR) has been demonstrated in the phase 2 Livify study in patients with renal impairment and fibrotic liver disease. Preclinical studies in mouse models of Alport syndrome and chronic kidney disease have shown beneficial effects on renal remodeling and function in ** mode. In 2023, Vonafexor was recognized by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) as a rare disease drug for Alport syndrome.
Dr. Jacky Vonderscher, Chief Executive Officer of Enyo Pharma, said: "We are pleased to have the support of our existing investors. In many kidney diseases with fibrotic or inflammatory components, there is a huge unmet need. Despite the current approach, these patients almost invariably deteriorate to end-stage renal disease. Vonafexor is our highly differentiated anti-inflammatory and fiber-lysing lead compound, and the results already obtained in patients with moderate renal impairment and in several preclinical regimens lead us to believe that it will greatly benefit those with rare kidney diseases such as Alport syndrome. ”
"Kidney disease has been largely neglected for decades, and it's refreshing to see teams like Enyo relentlessly develop Vonafexor for the benefit of these patients," said Iain Duke of Orbimed. ”
*: Business Wire).