GSK's Bepirovirsen Achieves Positive Phase III Results, Paving the Way for First Finite-Duration Functional Cure for Chronic Hepatitis B

On January 7, GSK announced positive results from its two pivotal Phase III trials, B-Well 1 (NCT05630807) and B-Well 2 (NCT05630820).

Screenshot source: Corporate official website

B-Well 1 and B-Well 2 Trials Evaluate Antisense Oligonucleotide (ASO) Bepirovirsen for TreatmentChronic Hepatitis BThe efficacy of (CHB) was evaluated in more than 1,800 patients from 29 countries.

Bepirovirsen (GSK836) is developed byAn ASO jointly developed by GSK and Ionis can inhibit the expression of HBsAg protein while stimulating an immune response through TLR8, activating the immune system to clear the virus from the circulatory system.

The results showed that the B-Well trial met the primary endpoint,BepirovirsenShowed a Functionally Curative Rate with Statistical and Clinical Significance. Functional cure rate of Bepirovirsen combined with standard treatmentSignificantly higher thanUse standard treatment alone. The results of all ranked endpoints are statistically significant, including patients with baseline surface antigen (HBsAg) ≤1000 IU/ml, in whom the efficacy is more pronounced.

In addition, Bepirovirsen has an acceptable safety and tolerability profile, consistent with results reported in other studies.

The full results will be submitted for presentation at an upcoming scientific congress, published in a peer-reviewed journal, and used to support regulatory submissions to health authorities around the world for Bepirovirsen. If approved, Bepirovirsen is expected to becomeThe First Six-Month Limited Course Treatment Regimen for Chronic Hepatitis B, and lay the foundation for future sequential treatment strategies.

Chronic hepatitis B (HBV) infection is one of the leading causes of liver disease worldwide. According to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)",China has approximately 86 million people with chronic hepatitis B virus infection and about 20 to 30 million patients with chronic hepatitis B.。

Achieving a cure for hepatitis B has always been a focus in the field of hepatitis B research in recent years.Difficulties and Hotspots. However,The emergence of small nucleic acid drugs has brought new hope for the functional cure of hepatitis B.Small nucleic acid drugs mainly include antisense oligonucleotides (ASO), small interfering RNA (siRNA), etc., which have high targeting compared with traditional drugs.

Globally, multiple hepatitis B clinical cure antisense oligonucleotide (ASO) and small interfering RNA (siRNA) candidate drugs are currently undergoing clinical research.

In addition to bepirovirsen, GSK has multiple small nucleic acid therapies for hepatitis B in development, such asGSK5637608(Original R&D code: JNJ-3989 (ARO-HBV) is currently in Phase II clinical trials. The siRNA drug developed in collaboration by Roche and Dicerna.Xalnesiran, which can target the conserved regions of the hepatitis B virus (HBV) genome to silence multiple HBV transcripts, may be effective for patients with chronic HBV infection, either in combination with or without immunomodulators.

Significant progress has also been made in the development of small nucleic acid drugs produced in China, including Brii Biosciences' HBV siRNA candidate drug.BRII-835（Elebsiran）, Ascletis Pharma (ASC22（Envafolimab）、Stellar Glory Kunze's Hepatitis B siRNA Candidate DrugHT-101, China Resources Tianqing's HBV siRNA Candidate DrugTQA-3038。

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