智通财经APP获悉,歌礼制药-B(01672)涨超7%,截至发稿,涨7.36%,报4.23港元,成交额568.12万港元。
消息面上,歌礼制药-B发布公告,ASC30口服片治疗肥胖症患者(体重指数(BMI):30-40kg/m2 )的美国单剂量递增(SAD)研究(NCT06680440)取得积极顶线结果。该SAD研究由5个队列(2毫克、5毫克、10毫克、20毫克和40毫克)组成,共计40名肥胖症患者,于空腹状态下进行。
ASC30口服片在Ia期SAD研究中整体安全性和耐受性良好。所有不良事件(AE)均为轻度(1级)或中度(2级),大部分AE与胃肠道(GI)相关。无3级或以上AE,也无严重不良事件(SAE)。ASC30口服片的GI相关安全性特征与其它在研小分子口服GLP-1R激动剂一致或更佳。此外,丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)和其它肝酶均在正常范围内。
ASC30是首款也是唯一一款既可每月一次皮下注射也可每日一次口服用于治疗肥胖症的小分子GLP-1R激动剂。基于其PK和安全性特征以及对GLP-1R的激动作用,ASC30口服片有望成为同类最佳的GLP-1R小分子激动剂。
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