BEIJING (dpa-AFX) - Ascletis Pharma Inc. (ASCLF.PK) announced positive topline results from its randomized, double-blind, placebo-controlled Phase Ib multiple ascending dose (MAD) study of ASC30 oral once-daily tablet in participants with obesity (body mass index (BMI): 30-40 kg/m2).
According to the company, the Phase Ib MAD study consisted of three cohorts, each with a different weekly titration scheme, for a total of four-week treatment and one-week follow up. Scheme 1 (mid starting dose, slow titration: 2 mg, 5 mg, 10 mg, and 20 mg); Scheme 2 (mid starting dose, normal titration: 2 mg, 10 mg, 20 mg, and 40 mg); and Scheme 3 (high starting dose, fast titration: 5 mg, 15 mg, 30 mg, and 60 mg).
The company noted that ASC30 oral once-daily tablet demonstrated a 6.5% placebo-adjusted mean body weight reduction from baseline after four-week treatment using weekly doses with titrations of 2 mg, 10 mg, 20 mg, and 40 mg doses.
ASC30 oral once-daily tablet also demonstrated a 4.5% placebo-adjusted mean body weight reduction from baseline after four-week treatment using weekly doses with titrations of 2 mg, 5 mg, 10 mg, and 20 mg doses. No vomiting was seen in this dose group.
Data from three different weekly titration schemes in the Phase Ib trial support utilizing a 'lower starting dose and slower titration' strategy for a 13-week Phase IIa study design of ASC30 oral once-daily tablet.
Both tolerability and efficacy data from the ASC30 tablet Phase Ib study support a 'lower starting dose and slower titration' strategy for a 13-week Phase IIa study design of ASC30 oral once-daily tablet. The 13-week Phase IIa study protocol, which has a low starting dose and slow weekly titration to the desired maintenance doses, has been submitted to the U.S. Food and Drug Administration (FDA) following a preliminary consultation with FDA, the company said.
The company expects to initiate the 13-week Phase IIa study in the U.S. at the beginning of the third quarter of 2025.
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