生物医药企业Palatin Technologies近日公布其口服MC4R激动剂PL7737在肥胖症动物模型中取得突破性临床前数据。实验显示，该候选药物在单药治疗四天后即实现快速且显著的减重效果。更值得注意的是，当PL7737与替西帕肽（tirzepatide）联用时，两者产生协同减重效应，减重幅度超越单一用药效果。
根据研发规划，Palatin将于2025年第四季度向美国食品药品监督管理局（FDA）提交PL7737的新药临床试验申请（IND），预计2026年上半年公布首个人体试验数据。公司同时筹备在2025年末启动I期单次/多次剂量递增临床试验，旨在评估该药物的安全性和耐受性。
值得关注的是，PL7737已获得美国FDA授予的孤儿药资格认定，适应症为瘦素受体缺乏症相关肥胖。这项认定将为该药物研发提供包括税费减免、加速审批在内的政策支持。随着全球肥胖药物市场规模持续扩张，此次积极数据或为Palatin在代谢疾病治疗领域奠定重要技术壁垒。
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