Tuesday, April 16, 2024

FDA Fast Track Designation for GSK’s Bepirovirsen Breakthrough Chronic Hepatitis B Therapy

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The U.S. Food and Drug Administration (FDA) has recently granted Fast Track designation to GSK’s innovative treatment, bepirovirsen, for chronic hepatitis B (CHB), marking a significant step forward in the management of this persistent viral infection. Bepirovirsen, a novel antisense oligonucleotide (ASO), is designed to target the RNA of the hepatitis B virus (HBV) directly, inhibiting its replication within infected liver cells. This investigational ASO is unique in its triple action mechanism, not only preventing viral replication but also stimulating an immune response through Toll-like receptor 8, aiding the body in achieving durable clearance of HBV from circulating blood.

GSK has positioned bepirovirsen as a groundbreaking treatment in the fight against CHB. It is the only single-agent therapy in Phase III development that has demonstrated the potential for a clinically meaningful functional cure response in combination with oral nucleoside/nucleotide analogs (NAs), according to GSK’s press release. This development is especially noteworthy given the complexity of HBV’s replication process and its ability to mutate, making the management of the virus particularly challenging.

FDA Accelerates Bepirovirsen Development After Positive Trial Outcomes

HBV, a hepaDNA virus, is typically diagnosed through a hepatitis B surface antigen (HBsAg) test, which indicates active infection. The primary strategy for managing HBV has historically focused on prevention, particularly through early vaccination. When the virus is transmitted from mother to infant, the prompt administration of hepatitis B immunoglobulin and the HBV vaccine within the first 24 hours of birth has proven effective. Treatments like interferon alfa have been used for those with active HBV infection to inhibit the virus’s protein synthesis and inactivate its DNA.

The FDA’s Fast Track designation decision to bepirovirsen was influenced by the promising results from the Phase IIb B-Clear and B-Sure clinical trials, which investigated the drug’s efficacy, safety, and durability of response in patients with CHB. The B-Clear trial demonstrated that bepirovirsen could effectively reduce HBsAg levels and HBV DNA after 24 weeks of treatment in CHB patients, either on stable NA treatment or not.

Fast Track Designation

Pioneering a Potential Functional Cure for Chronic Hepatitis B with FDA’s Fast Track Designation

Specifically, a 24-week treatment with 300 mg of bepirovirsen resulted in HBsAg levels and HBV DNA falling below the Lower Limit of Quantification (LLOQ) in a significant proportion of patients, showcasing the drug’s potential to significantly impact viral suppression. Building on these findings, the B-Sure trial aims to assess the long-term efficacy and response durability of bepirovirsen for participants from the B-Clear study over an additional 33 months. This trial includes an evaluation of the feasibility of halting NA treatment to explore the possibility of achieving a functional cure, characterized by the absence of serologic evidence of HBsAg or HBV DNA in patients who discontinue their medication.

This recent FDA Fast Track designation for bepirovirsen in treating CHB highlights the ongoing efforts to develop more effective treatments for hepatitis B, a virus that continues to pose a significant public health challenge worldwide. By targeting the virus’s replication mechanism and stimulating the body’s immune response, bepirovirsen offers hope for a functional cure for CHB, potentially transforming the treatment landscape for patients with this chronic condition.

As GSK continues to advance the clinical development of bepirovirsen, the healthcare community eagerly awaits further data that could solidify the drug’s role in combating chronic hepatitis B and improving patient outcomes.


Resource: Pharmexec, February 13, 2024

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