Ascletis Pharma Inc.’s wholly-owned company, Gannex, has reportedly announced the positive clinical data from its ASC41 trial conducted among overweight and obese subjects. The active metabolite of this liver-targeted prodrug is selective THR-β (thyroid hormone receptor beta) agonist.
In the clinical trial, 20 overweight & obese subjects with LDL-C (low-density lipoprotein cholesterol) were examined. They are treated with 10 mg oral tablets of ASC41 or matching placebo tablets once in a week in this double-blind, randomized, placebo-controlled clinical trial.
As per the preliminary data, following nearly 28 days of oral dosing, the study participants demonstrated a clinically meaningful, sustainable, and statistically significant reduction in TG (triglyceride), LDL-C, and TC (total cholesterol), as compared to placebo. Additionally, the level of HDL-C (high-density lipoprotein cholesterol) remained relatively unchanged.
In this clinical study, there has been a relatively benign adverse event profile of ASC41. Majority of the adverse reactions were grade 1 or 2, with only three grade 3 cases (two in the ASC41 group and one in the placebo group). In addition, there were no serious adverse reactions.
According to Gannex’s Chief Medical Officer, Melissa Palmer, MD, the company showed excitement towards the completion of the ASC41 study among overweight and obese subjects suffering from elevated LDL-C, as they are prone to NAFLD (nonalcoholic fatty liver disease). The recently announced clinical data provided crucial safety and preliminary efficacy readouts that will enable it to advance the clinical program further to evaluate patients with NASH.
As per the statement made by the Founder, Chairman, & CEO of Ascletis, Dr. Jinzi J. Wu, the company has been rapidly advancing its NASH pipeline with 3 targets namely FXR, THR-β, and FASN. This is evident from the positive results of the ASC41 trial conducted among overweight and obese participants, as well as its participation in Sagimet’s recent $80 million crossover financing round led by global premium investors.
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