Hepathera's Anti-HBV siRNA Drug HT-101 Receives FDA Clearance for Phase 1b Clinical Trial

Feb 04, 2024 12:23 CST Updated 12:23

Hepa Thera

Innovative Drug Developer in the Field of Hepatology

▎Edited by the WuXi AppTec content team

On February 4, Hepa Thera announced that the clinical trial application for its new anti-hepatitis B drug HT-101 has been approved by the U.S. FDA, and will directly proceed to...For chronic hepatitis B virus infectionPhase 1b clinical trial. HT-101 is aAnti-HBVSmall interfering RNA (siRNA）Drug。

siRNA drugs are an emerging new technology in recent years, with the advantages of multiple druggable targets, strong efficacy, good safety, and low dosing frequency. Their indications cover a wide range, including cardiovascular diseases, rare diseases, neurological disorders, viral hepatitis, ophthalmic diseases, and cancer, making them one of the most promising frontier pharmaceutical fields globally.

HT-101 Injection is an innovative siRNA drug conjugated with GalNAc.By interfering with the mRNA of the hepatitis B virus, disrupting its function as a post-transcriptional translation template, and preventing the synthesis of related viral proteins, the formation of hepatitis B virus particles is inhibited., used for the treatment of chronic hepatitis B virus infection.

According to the press release from Hepa Thera,HT-101 injection has completed all studies in healthy volunteers and all dosing in Phase 1b clinical trials in patients with chronic hepatitis B in China. Preliminary research data indicate that the product demonstrates good safety and tolerability in both healthy populations and patients with chronic hepatitis B, andSignificantly reduces hepatitis B surface antigen (HBsAg) in patients with chronic hepatitis B; the reduction of HBsAg in the medium- and high-dose groups reaches more than 2 lg without significant rebound.。

Public information shows that Hepa Thera was established in May 2021. It is a company incubated by Fosun Pharma's New Drug Fund, focusing onField of Liver Disease TreatmentBiotechnology company for innovative drug development.Hepa Thera focuses on technologies such as RNA interference, antibodies, fusion proteins, and gene editing, aiming to address unmet needs in the treatment of liver diseases including hepatitis B, non-alcoholic fatty liver disease, liver fibrosis, cirrhosis, and autoimmune liver diseases.

In addition to the recent clinical approvalGalNAc-siRNADrugHT-101，Hepa Thera Another ProductInnovative drugs for hepatitis B treatment,Fully Human Monoclonal Antibody HT-102 Targeting HBVHas also entered the clinical research stage.Hepa Thera Follow-upA Phase 2 clinical trial will explore the functional cure of hepatitis B with the combination of two drugs.

References:

[1]Good News | Hepa Thera's New Hepatitis B Drug HT-101 (siRNA) Approved for Clinical Trials by FDA. Retrieved Feb 4, 2024, from https://mp.weixin.qq.com/s/zkeSlzZi6XAM_4hnU0E38w

[2] Hepa Thera's Neutralizing Antibody Product HT-102 Phase Ib Clinical Trial Officially Launched. Retrieved July 31, 2023, from https://mp.weixin.qq.com/s/YVnytoKiS9cV_gEZ8L6Fuw

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