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 with a BMI of 30-40 kg/m² [1][2] - The study demonstrated that higher drug exposure levels correlate with more significant weight loss, with a 4.5% reduction in weight for the 20 mg cohort and a 6.5% reduction for the 40 mg cohort after 28 days of treatment [1][3] Group 1: Pharmacokinetics and Weight Loss - In the Phase Ib MAD study, the drug exposure levels (AUC0-24h) for the 20 mg and 40 mg cohorts were 3,560 ng.h/mL and 5,060 ng.h/mL, respectively [1] - The weight loss results were consistent with the drug exposure levels, indicating that higher exposure leads to more pronounced weight loss effects [1][3] Group 2: Comparison with Orforglipron - ASC30's drug exposure levels were approximately 2.3 times and 3.3 times higher than those of orforglipron (24 mg cohort), which had an AUC0-24h of 1,520 ng.h/mL [2] - The weight loss achieved with orforglipron after 28 days was only 3.6%, indicating that ASC30 may offer superior efficacy in weight reduction [2] Group 3: 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 observed [3] - No elevations in liver enzymes or other abnormalities were noted during the study, suggesting a favorable safety profile for ASC30 [3] Group 4: Competitive Positioning - The company believes that the higher drug exposure levels of ASC30 will lead to more significant weight loss compared to other small molecule GLP-1 receptor agonists, including orforglipron [3] - The data from non-human primate studies, which showed higher drug exposure for ASC30, has been successfully translated into human clinical research, enhancing the competitive and differentiated potential of ASC30 in treating obesity [3]
歌礼制药-B(01672)：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