{"id":271935,"date":"2024-01-04T05:00:15","date_gmt":"2024-01-04T05:00:15","guid":{"rendered":"https:\/\/hamslivenews.com\/?p=271935"},"modified":"2024-01-04T07:29:10","modified_gmt":"2024-01-04T07:29:10","slug":"enyo-pharma-announces-a-e39-million-series-c-financing-and-fda-clearance-to-advance-vonafexor-in-a-phase-2-clinical-trial-for-patients-with-alport-syndrome","status":"publish","type":"post","link":"https:\/\/www.hamslive.com\/news\/2024\/01\/enyo-pharma-announces-a-e39-million-series-c-financing-and-fda-clearance-to-advance-vonafexor-in-a-phase-2-clinical-trial-for-patients-with-alport-syndrome\/","title":{"rendered":"ENYO Pharma Announces a \u20ac39 Million Series C Financing and FDA Clearance to Advance Vonafexor in a Phase 2 Clinical Trial for Patients With Alport Syndrome"},"content":{"rendered":"<p><b>Business Wire India<\/b><\/p>\n<ul>\n<li><em><strong>The Company will initiate a Phase 2 clinical study of Vonafexor in Alport Syndrome &#8211; called \u201cALPESTRIA-1\u201d &#8211; in the first half of 2024.<\/strong><\/em><\/li>\n<li><em><strong>Series C proceeds will fund the Phase 2 study, as well as operations and further R&amp;D through the first half of 2026.<\/strong><\/em><\/li>\n<\/ul>\n<p>ENYO Pharma (\u201cENYO\u201d) 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.<\/p>\n<p>This press release features multimedia. View the full release here: <a href=\"https:\/\/www.businesswire.com\/news\/home\/20240103067331\/en\/\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/www.businesswire.com\/news\/home\/20240103067331\/en\/<\/a><\/p>\n<div>\n<p><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20240103067331\/en\/1986841\/4\/Kidneys_blue_and_red.jpg\" alt=\"(Photo: Business Wire)\" \/><\/p>\n<p>(Photo: Business Wire)<\/p>\n<\/div>\n<p>Furthermore, ENYO announced the first closing of a 39 million \u20ac 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.<\/p>\n<p>The clearance of ENYO\u2019s IND represents a significant milestone for the company as it embarks on its first clinical trial focusing on renal disease. ENYO\u2019s 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.<\/p>\n<p>\u201d<i> We are delighted with this support from our existing investors\u201d<\/i> said <b>Dr. Jacky Vonderscher, CEO at ENYO Pharma.<\/b> \u201c<i>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. \u201c<\/i><\/p>\n<p>\u201d <i>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. <\/i>\u201c said <b>Iain Dukes of OrbiMed<\/b>.<\/p>\n<p><b>About ENYO Pharma: <\/b><br \/>\nFor more information :\u00a0<a href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.enyopharma.com%2F&amp;esheet=53876570&amp;newsitemid=20240103067331&amp;lan=en-US&amp;anchor=ENYO+Pharma+%26%238211%3B+Developing+therapeutics+for+diseases+with+impaired+kidney+function&amp;index=1&amp;md5=6306d691447c219301f0027da3cc51c6\" target=\"_blank\" rel=\"nofollow noopener\" shape=\"rect\">ENYO Pharma \u2013 Developing therapeutics for diseases with impaired kidney function<\/a><\/p>\n<p><b>About OrbiMed:<\/b><\/p>\n<p>For more information :\u00a0<a href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.orbimed.com%2F&amp;esheet=53876570&amp;newsitemid=20240103067331&amp;lan=en-US&amp;anchor=OrbiMed&amp;index=2&amp;md5=526fce64f0ccbecafb1a4ebf44ad4f16\" target=\"_blank\" rel=\"nofollow noopener\" shape=\"rect\">OrbiMed<\/a><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20240103067331r1&amp;sid=bwiftp&amp;distro=ftp\" alt=\"\" \/><\/p>\n<p>View source version on businesswire.com: <a href=\"https:\/\/www.businesswire.com\/news\/home\/20240103067331\/en\/\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/www.businesswire.com\/news\/home\/20240103067331\/en\/<\/a><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/cms.businesswireindia.com\/images\/pixel.gif\" alt=\"\" width=\"0\" height=\"0\" border=\"0\" \/><\/p>\n<div class=\"fb-background-color\">\n\t\t\t  <div \n\t\t\t  \tclass = \"fb-comments\" \n\t\t\t  \tdata-href = \"https:\/\/www.hamslive.com\/news\/2024\/01\/enyo-pharma-announces-a-e39-million-series-c-financing-and-fda-clearance-to-advance-vonafexor-in-a-phase-2-clinical-trial-for-patients-with-alport-syndrome\/\"\n\t\t\t  \tdata-numposts = \"10\"\n\t\t\t  \tdata-lazy = \"true\"\n\t\t\t\tdata-colorscheme = \"light\"\n\t\t\t\tdata-order-by = \"social\"\n\t\t\t\tdata-mobile=true>\n\t\t\t  <\/div><\/div>\n\t\t  <style>\n\t\t    .fb-background-color {\n\t\t\t\tbackground: #ffffff !important;\n\t\t\t}\n\t\t\t.fb_iframe_widget_fluid_desktop iframe {\n\t\t\t    width: 100% !important;\n\t\t\t}\n\t\t  <\/style>\n\t\t  ","protected":false},"excerpt":{"rendered":"<p>Business Wire India The Company will initiate a Phase 2 clinical study of Vonafexor in Alport Syndrome &#8211; called \u201cALPESTRIA-1\u201d &#8211; in the first half of 2024. Series C proceeds will fund the Phase 2 study, as well as operations and further R&amp;D through the first half of 2026. ENYO Pharma (\u201cENYO\u201d) announced that it [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":271936,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[52,47,45],"tags":[9306,9305,23,164],"class_list":{"0":"post-271935","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-economy","8":"category-health","9":"category-india","10":"tag-clinical-trail","11":"tag-enyo-pharma","12":"tag-health","13":"tag-india"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ENYO Pharma Announces a \u20ac39 Million Series C Financing and FDA Clearance to Advance Vonafexor in a Phase 2 Clinical Trial for Patients With Alport Syndrome<\/title>\n<meta name=\"description\" content=\"The Company will initiate a Phase 2 clinical study of Vonafexor in Alport 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