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Ascletis Announces Favorable and Differentiated Pharmacokinetic Profile of ASC30 Oral Once-Daily Tablet in Its U.S. Phase Ib Multiple Ascending Dose Study
Ascletis Pharma Inc. (HKEX:1672, "Ascletis") today announces promising topline pharmacokinetic (PK) data from its randomized, double-blind, placebo-controlled Phase Ib multiple ascending dose (MAD) study (NCT06680440), conducted in the U.S., of ASC30 oral once-daily tablet in participants with obesity (body mass index (BMI): 30-40 kg/m2). At steady state, ASC30 demonstrated drug exposures (area under the curve over 0-24 hours or AUC0-24h) of 3,560 ng•h/mL and 5,060 ng•h/mL for cohort 1 (20 mg) a
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[{"type":"text","content":"- ASC30 oral once-daily tablet demonstrated approximately 2.3-fold to 3.3-fold greater drug exposure than orforglipron in a cross-trial comparison.","length":206,"tagName":"p"},{"type":"text","content":"- Higher drug exposure and favorable tolerability profile positions ASC30 oral once-daily tablet favorably compared to orforglipron.","length":186,"tagName":"p"},{"type":"text","content":"- Topline data from the Ascletis' U.S. Phase IIa study for ASC30 in participants with obesity or overweight are expected in the fourth quarter of 2025.","length":213,"tagName":"p"},{"type":"text","content":"HONG KONG, Aug. 27, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") today announces promising topline pharmacokinetic (PK) data from its randomized, double-blind, placebo-controlled Phase Ib multiple ascending dose (MAD) study (NCT06680440), conducted in the U.S., of ASC30 oral once-daily tablet in participants with obesity (body mass index (BMI): 30-40 kg/m2). At steady state, ASC30 demonstrated drug exposures (area under the curve over 0-24 hours or AUC0-24h) of 3,560 ng•h/mL and 5,060 ng•h/mL for cohort 1 (20 mg) and cohort 2 (40 mg) , respectively, in the Phase Ib MAD study. These drug exposure data are consistent with placebo-adjusted mean body weight reduction from baseline of 4.5% for cohort 1 (20 mg) and 6.5% for cohort 2 (40 mg) after 28-day treatment, indicating higher drug exposures are associated with greater weight loss.","length":898,"tagName":"p"},{"type":"text","content":"Based on a cross-trial comparison, 20 mg and 40 mg ASC30 oral once-daily tablet demonstrated greater drug exposure of approximately 2.3-fold and 3.3-fold, respectively, of orforglipron oral once-daily capsule (24 mg cohort, AUC0-24h 1,520 ng•h/mL) [1]. After 28-day treatment, orforglipron (24 mg cohort, AUC0-24h 1,520 ng•h/mL) resulted in only 3.6% placebo-adjusted mean body weight reduction from baseline [1]. Despite high drug exposure of ASC30 in cohort 1 (20 mg, AUC0-24h 3,560 ng•h/mL), there were no incidences of vomiting in cohort 1 (20 mg), whereas orforglipron 24 mg cohort (AUC0-24h 1,520 ng•h/mL) had 18% vomiting[1], ...