Vonafexor

LYON, France--( BUSINESS WIRE )--ENYO Pharma (“ENYO”) announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical study of Vonafexor, a highly selective FXR agonist, for the treatment of Alport Syndrome. Furthermore, ENYO announced the first closing of a 39 million € Series C equity financing, positioning ENYO as an emerging biotechnology company in the field of renal diseases. The financing will support the Phase 2 Alpestria-1 study and further profiling of Vonafexor in other kidney diseases, such as Autosomal Dominant Polycystic Kidney Disease (ADPKD). The financing was co-led by OrbiMed and Morningside Ventures with participation from other existing investors including AndEra Partners, Bpifrance InnoBio and Bpifrance Large Ventures. The clearance of ENYO’s IND represents a significant milestone for the company as it embarks on its first clinical trial focusing on renal disease. ENYO’s lead candidate Vonafexor, as well as fast follower EYP651, are highly specific FXR agonists given as once-daily oral treatments. Both compounds have strong fibrolytic and anti-inflammatory properties that are broadly applicable across several renal diseases. Vonafexor effect on renal function (eGFR) was already shown in the Phase 2 LIVIFY study of patients with both kidney impairment and fibrotic liver disease. Preclinical studies in both Alport syndrome and Chronic Kidney Disease mouse models showed beneficial effects of Vonafexor on kidney remodeling and function in a curative mode. In 2023, Vonafexor was granted as Orphan Drug Designation (ODD) by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for Alport syndrome. ” We are delighted with this support from our existing investors” said Dr. Jacky Vonderscher, CEO at ENYO Pharma. “ There are huge unmet needs in many kidney diseases with fibrosis or inflammatory components. These patients almost invariably progress to end-stage kidney disease despite current therapies. The results already obtained with Vonafexor, our highly differentiated anti-inflammatory and fibrolytic lead compound, in patients with moderate kidney impairment and in several preclinical protocols, make us confident that it will greatly benefit to those patients with rare kidney diseases like Alport syndrome. “ ” Kidney diseases were somewhat neglected for decades, and it is refreshing to see a team like ENYO pursuing with persistence the development of Vonafexor for the benefit of these patients. “ said Iain Dukes of OrbiMed . About ENYO Pharma: For more information : ENYO Pharma – Developing therapeutics for diseases with impaired kidney function About OrbiMed: For more information : OrbiMed

Los Angeles, USA , Jan. 13, 2021 (GLOBE NEWSWIRE) -- Nonalcoholic Steatohepatitis Drug Pipeline Analysis Review, 2020 NASH Drug Pipeline Shows Promise as 95+ companies are working for Nonalcoholic Steatohepatitis Drug Development “Nonalcoholic Steatohepatitis (NASH) Pipeline Insight, 2020” by DelveInsight highlights the details around the NASH pipeline scenario, unmet needs, and NonAlcoholic Steatohepatitis therapeutic assessment of the key pipeline therapies. Some of the key Nonalcoholic Steatohepatitis Pipeline Highlights Nonalcoholic Steatohepatitis (NASH) is a form of fatty liver disease that can cause inflammation, and over the long term, can lead to scarring of the liver. Nonalcoholic Steatohepatitis symptoms include fatigue and pain in the upper right abdomen. There is no standard treatment for NASH patients, but lifestyle changes have influenced its progression. Get access to NASH Treatment Pipeline Sample Report NASH Pipeline Therapeutics ENYO Pharma develops EYP001, which is an orally bioavailable synthetic non-steroidal, non-bile acid FXR agonist small molecule that is also developed for NASH.  FXR agonists could become the backbone of any future NASH therapies. The pioneering ENYO founding team discovered that FXR agonists interfere with the interaction between FXR and HBx, a hepatitis B viral protein essential for replicating the virus. It has demonstrated its efficacy in a Stelic mouse model (STAMTM) with a significant positive impact on most of the NASH key parameters (Fibrosis, Steatosis, Inflammation, Ballooning, triglycerides, and NAS). It differentiates from other FXR agonists with a potentially better C4/FGF19 balance. To learn more about NASH Drugs Development, request NASH Treatment Pipeline Sample Report Scope of Nonalcoholic Steatohepatitis Drug Pipeline Report Key Questions regarding Current NASH Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents  Browse Detailed TOC, Emerging Drugs and Key Companies @ NASH Pipeline Scenario Related Reports DelveInsight's Nonalcoholic Steatohepatitis (NASH) Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and in depth understanding of historical and forecasted epidemiology. DelveInsight's Nonalcoholic Steatohepatitis (NASH) Epidemiology Forecast 2030 report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology of Nonalcoholic Steatohepatitis (NASH) in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. DelveInsight' s Non Alcoholic Fatty Liver Disease (NAFLD) Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and in depth understanding of historical and forecasted epidemiology. DelveInsight's Non Alcoholic Fatty Liver Disease (NAFLD) Epidemiology Forecast 2030 report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology of Non Alcoholic Fatty Liver Disease (NAFLD) in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. Non Alcoholic Fatty Liver Disease (NAFLD) Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2020 " report by DelveInsight offers comprehensive insights on marketed and Phase III products for Non Alcoholic Fatty Liver Disease (NAFLD). Non Alcoholic Fatty Liver Disease (NAFLD) Pipeline Insight, 2020 report by DelveInsight outlays comprehensive insights of present clinical development scenario and growth prospects across the Non Alcoholic Fatty Liver Disease (NAFLD) market. DelveInsight's Hepatitis C Market Insights, Epidemiology and Market Forecast - 2030 report provides detailed insights on historical and forecasted epidemiology. About DelveInsightDelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end to end comprehensive solutions to improve their performance.