Gannex to Present Positive Interim 12-Week Results from ASC41 Phase II Trial at EASL 2024

Gannex Pharma Co., Ltd., a subsidiary of Ascletis Pharma Inc., has unveiled promising results for its drug candidate, ASC41, in the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The findings were shared via a poster presentation at the European Association for the Study of the Liver (EASL) Congress 2024, held in Milan, Italy.

ASC41, a selective thyroid hormone receptor β (THRβ) agonist, demonstrated significant reductions in liver fat content as well as notable improvements in key liver biomarkers. After a 12-week treatment period with ASC41, MASH patients exhibited a mean relative reduction in liver fat content of up to 68.2% from baseline. This reduction was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF), which is a strong predictor of fibrosis reduction.

In addition to liver fat reduction, patients treated with ASC41 also showed significant decreases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels, enzymes that are crucial indicators of liver function and inflammation. The improvements in liver enzymes highlight ASC41's potential in mitigating hepatic injury and malfunction. Furthermore, the treatment led to reductions in low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and triglycerides (TG), which could lower the risk of cardiovascular events.

Safety and tolerability profiles for ASC41 were excellent, with the majority of adverse events reported being of grade 1 severity. No serious adverse events were related to the treatment, underscoring its safety for clinical use. ASC41's formulation, a once-daily oral tablet, was developed using Ascletis' proprietary technology and has already shown no significant drug-drug interactions with commonly used antidepressants and statins in U.S. Phase I studies.

The Phase II clinical trial for ASC41, conducted in China, is a randomized, double-blind, placebo-controlled, multi-center study. The trial aims to enroll approximately 180 liver biopsy-confirmed MASH patients, who will be randomized into two treatment cohorts of ASC41 (2 mg or 4 mg) and one placebo cohort. The study's duration is 52 weeks, with a 4-week follow-up. Interim results after 12 weeks of treatment showed that 93.3% of patients experienced at least a 30% relative reduction in liver fat content, according to MRI-PDFF assessments.

Dr. Jinzi J. Wu, Founder, Chairman, and CEO of Ascletis, expressed optimism about ASC41's potential, citing the drug's impact on liver fat content and inflammatory biomarkers as strong indicators of its efficacy. Dr. Wu also highlighted the drug's excellent safety and tolerability, positioning ASC41 as a potential best-in-class THRβ agonist.

Gannex Pharma Co., Ltd., founded in 2019, focuses on the R&D and commercialization of new drugs aimed at MASH. The company has developed two clinical-stage drug candidates targeting distinct pathways: THRβ (ASC41) and fatty acid synthase (ASC40).

Ascletis Pharma Inc., listed on the Hong Kong Stock Exchange, is a biotech firm with a comprehensive value chain from drug discovery and development to manufacturing. The company is dedicated to addressing unmet medical needs in viral diseases, MASH, and oncology. Its robust pipeline includes several clinical-stage drug candidates, such as ASC22 for chronic hepatitis B, ASC40 for acne and recurrent glioblastoma, and ASC61 for advanced solid tumors.

The promising interim results of ASC41 provide a significant step forward in the treatment of MASH, offering hope for better management of this challenging liver condition. Further results from the ongoing Phase II clinical trial will be eagerly awaited.