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歌礼制药-B:ASC30每日一次口服片在美国Ib期多剂量递增研究中展现出良好且具差异化的药代动力学特征

Core Insights - The announcement from the company indicates positive topline pharmacokinetic (PK) data for ASC30, an oral tablet administered once daily, in a Phase Ib multiple ascending dose (MAD) study involving obese subjects [1][2][3] - The study demonstrated that higher drug exposure levels correlate with more significant weight loss, with a 4.5% reduction in the 20 mg cohort and a 6.5% reduction in the 40 mg cohort after 28 days of treatment [1][3] Group 1: Drug Exposure and Weight Loss - In the Phase Ib MAD study, ASC30 drug exposure levels (AUC0-24h) reached 3,560 ng.h/mL for the 20 mg cohort and 5,060 ng.h/mL for the 40 mg cohort, showing a direct relationship with weight loss outcomes [1] - Comparative analysis revealed that ASC30's drug exposure was approximately 2.3 times and 3.3 times higher than orforglipron's exposure at 24 mg, which resulted in a weight loss of only 3.6% [2] Group 2: Safety and Tolerability - The ASC30 oral tablet demonstrated good safety and tolerability, with no serious adverse events (SAEs) reported and no grade 3 or higher adverse events, including gastrointestinal issues [3] - Laboratory tests and vital signs showed no abnormalities, and there were no elevations in liver enzymes during the treatment period [3] Group 3: Competitive Positioning - The company believes that the higher drug exposure levels of ASC30 will lead to more significant weight loss effects compared to small molecule GLP-1 receptor agonists, including orforglipron [3] - The CEO expressed excitement over the data indicating ASC30's competitive and differentiated potential in treating obesity, based on its superior pharmacokinetic profile [3]