GST-HG131 / Fujian Cosunter - LARVOL DELTA

GST-HG131-II-01: A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Fujian Akeylink Biotechnology Co., Ltd. | Trial completion date: Nov 2024 ➔ May 2025 | Trial primary completion date: Sep 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Fujian Akeylink Biotechnology Co., Ltd.

New P2 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Discovery and preclinical evaluations of GST-HG131, a novel HBV antigen inhibitor for the treatment of chronic hepatitis B infection. (PubMed, Bioorg Med Chem Lett) - P1 | "GST-HG131 improved safety in rat toxicology studies over RG7834. The promising inhibitory activity, together with animal safety enhancement, merited GST-HG131 progressed into clinical development in 2020 (NCT04499443)."

Journal • Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Safety, Tolerability, and Pharmacokinetics of the Novel Hepatitis B Virus Expression Inhibitor GST-HG131 in Healthy Chinese Subjects: a First-in-Human Single- and Multiple-Dose Escalation Trial. (PubMed, Antimicrob Agents Chemother) - P1 | "These findings imply GST-HG131 has potential as a therapeutic option for CHB infection. (This study has been registered at ClinicalTrials.gov under identifier NCT04499443.)."

Journal • P1 data • PK/PD data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

[VIRTUAL] Novel hepatitis B virus gene expression inhibitor in clinical development (EASL-ILC 2021) - " GST-HG131 potently inhibited secretion of HBsAg (EC50 = 3.4 ± nM), HBeAg (EC50 = 8 nM, and HBV DNA (EC50 = 3.3 ± 1.7 nM) from HepG2 2.15 cells in the absence of cytotoxicity (CC50 >100 microM), and was additive with Entecavir...Combination with Tenofovir resulted in additivity... GST-HG131 is a novel, orally-bioavailable inhibitor of HBV gene expression. It has an excellent antiviral potency in vitro, efficacy in vivo, and is well-tolerated in rodents. The molecular mechanism of GST-HG131 antiviral action, including strong inhib- ition of HBsAg secretion, involves binding to and inhibition of TENT4B, leading to shortening of poly-adenylation tail of HBV mRNAs, and thus accelerating its degradation."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Guangshengtang (300436.SZ) obtains patent certificate or authorization notice for some innovative drugs under research [Google translation] (Sina Corp) - "Guangshengtang...has obtained a patent certificate or authorization notice for an innovative drug under development. The details are as follows:...Innovative hepatitis B treatment drug GST-HG141 obtained Eurasian patent authorization notice, hepatitis B treatment innovative drugs GST-HG131, GST-HG121 obtained U.S. and Taiwan patent certificates or authorization notices..."

Patent • Hepatitis B • Infectious Disease

Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of GST-HG131 Tablets (clinicaltrials.gov) - P1; N=124; Recruiting; Sponsor: Fujian Cosunter Pharmaceutical Co. Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hepatitis B • Hepatology • Infectious Disease