Lpath有限公司宣布FDA已完成对其单抗药勒派斯单抗(lpathomab)研究性新药申请的评阅工作。FDA已通知公司可开始Ⅰ期临床试验。基于该药研究性新药申请的批准,公司在2个月内将开始Ⅰ期临床试验。该药靶向溶血磷脂酸(一种对神经损伤和神经病痛有重要作用的生物活性酯),临床前研究显示其对多种疼痛模型有效,提示可用于治疗慢性疼 Lpath Ltd announced that it has completed its review of its new monoclonal antibody lpathomab investigational new drug application. FDA has informed the company that Phase I clinical trials can begin. Based on the approval of the drug’s investigational new drug application, the company will start Phase I clinical trials within 2 months. The drug targets lysophosphatidic acid, a biologically active ester that plays an important role in nerve injury and neuropathic pain, and preclinical studies have shown it to be effective in a variety of pain models, suggesting that it may be useful in the treatment of chronic pain