智通财经APP获悉,Organovo Holdings今日宣布,礼来(LLY.US)(Eli Lilly and Company)将收购该公司旗下的FXR项目及主打疗法FXR314。FXR314是一款潜在“best-in-class”的口服FXR小分子激动剂。目前,Organovo已获得美国FDA的临床试验许可,正在进行其主打疗法FXR314用于治疗溃疡性结肠炎(UC)的2期试验。
公司通过其专有的3D人体组织模型,制定了针对FXR314的高效临床开发策略,该策略不仅适用于溃疡性结肠炎,也可用于治疗包括克罗恩病在内的其他炎症性肠病。Organovo同时推动FXR314在治疗肝脏疾病方面的应用,包括代谢相关性脂肪性肝炎(MASH)和原发性胆汁性胆管炎。初步临床试验结果表明,FXR314具备高效力、安全性和良好耐受性,并有望规避其他FXR靶向药物常见的剂量限制性毒性问题。
根据协议,Organovo将获得一笔预付款,并在FXR314达成关键监管和商业里程碑时获得相应款项。礼来则将获得Organovo的FXR项目在全球范围内的全部商业开发权利。
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