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..

法国里昂--（商业新闻短讯）--ENYO Pharma（“ENYO”）宣布，其研究性新药（IND）申请已获得美国食品和药物管理局（FDA）的批准，以启动Vonafexor（一种高选择性FXR激动剂）的2期临床研究，用于治疗Alport综合征。。

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).

此外，ENYO宣布首次关闭3900万欧元的C系列股权融资，将ENYO定位为肾脏疾病领域的新兴生物技术公司。这笔资金将支持2期Alpestria-1研究，并进一步分析Vonafexor在其他肾脏疾病中的作用，例如常染色体显性多囊肾病（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..

此次融资由OrbiMed和Morningside Ventures共同牵头，其他现有投资者包括AndEra Partners、Bpifrance InnoBio和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.

ENYO的IND获得批准对于该公司来说是一个重要的里程碑，因为它开始了第一次针对肾脏疾病的临床试验。ENYO的主要候选药物Vonafexor以及快速追随者EYP651是高度特异性的FXR激动剂，每天口服一次。这两种化合物都具有很强的纤溶和抗炎特性，广泛适用于多种肾脏疾病。

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.

Vonafexor对肾功能（eGFR）的影响已经在肾功能不全和纤维化肝病患者的2期LIVIFY研究中显示出来。Alport综合征和慢性肾病小鼠模型的临床前研究表明，Vonafexor在治疗模式下对肾脏重塑和功能有益。

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..

2023年，Vonafexor被欧洲药品管理局（EMA）和美国食品和药物管理局（FDA）授予Alport综合征孤儿药称号（ODD）。。

” 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.

ENYO Pharma首席执行官JackyVonderscher博士表示：“我们很高兴得到现有投资者的支持。”。“许多患有纤维化或炎症成分的肾脏疾病存在巨大的未满足需求。尽管目前有治疗方法，但这些患者几乎总是进展为终末期肾脏疾病。

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.

Vonafexor（我们高度分化的抗炎和纤溶先导化合物）在中度肾功能不全患者和几种临床前方案中已经获得的结果使我们相信，它将对那些患有Alport综合征等罕见肾脏疾病的患者大有裨益。

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” 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.

“几十年来，肾脏疾病在某种程度上被忽视了，看到像ENYO这样的团队为了这些患者的利益而坚持不懈地追求Vonafexor的发展，这令人耳目一新。奥比德的伊恩·杜克斯说。

About ENYO Pharma:

关于ENYO Pharma：

For more information : ENYO Pharma – Developing therapeutics for diseases with impaired kidney function

更多信息：ENYO Pharma–开发肾功能受损疾病的治疗方法

About OrbiMed:

关于OrbiMed：

For more information : OrbiMed

更多信息：OrbiMed