Ascletis Pharma’s Gannex has reported positive results from a clinical trial of its liver-targeted prodrug, ASC41, in overweight and obese participants with high low-density lipoprotein cholesterol (LDL-C).
ASC41’s active metabolite is a selective thyroid hormone receptor beta (THR-β) agonist.
The randomised, double-blind, placebo-controlled clinical study enrolled 20 overweight and obese participants with LDL-C greater than 110mg/dL. They were given ASC41 10mg oral tablets or a placebo once daily.
Preliminary data showed that subjects receiving oral ASC41 treatment for more than 28 days had a sustainable, clinically meaningful and statistically significant reduction in LDL-C, triglyceride (TG), total cholesterol (TC), versus placebo.
Furthermore, no major change in high-density lipoprotein cholesterol (HDL-C) was observed.
The drug had a relatively benign adverse event profile with no serious adverse events (SAEs).
Gannex chief medical officer Melissa Palmer said: “We are excited about the completion of this clinical study in overweight and obese subjects with elevated LDL-C, as this population is characteristic of nonalcoholic fatty liver disease (NAFLD).
“The data from this study offered important safety and preliminary efficacy readouts that enable us to advance this clinical programme into patients with NASH.”
The company focuses on the research and development (R&D) and commercialisation of new drugs for nonalcoholic steatohepatitis (NASH). It has three clinical-stage drug candidates against three different targets, namely FASN, THR-beta and FXR, in addition to three pre-clinical stage combination therapies.
Ascletis founder, chairman and CEO Dr Jinzi Wu said: “With the positive clinical results in overweight and obese subjects for ASC41 and the company’s participation in recent Sagimet’s $80m crossover financing with global premium investors, we are moving forward at full speed for our global leading NASH pipeline with three different targets, FASN, THR-β and FXR.”
In February last year, Ascletis Pharma announced that three patients being treated with Ganovo plus Ritonavir as part of a Novel Coronavirus Pneumonia clinical trial in China were discharged from hospital.