GSK's Class 1 Hepatitis B Drug GSK3228836 Granted Clinical Trial Approval in China, Offering New Hope for Patients

　　【Pharmaceutical Network Product Information】Hepatitis B is a common disease. Due to the lack of obvious early symptoms, patients often seek medical attention late. Many patients may already have progressed to liver cirrhosis or even liver cancer at the time of diagnosis, seriously affecting their health and safety. Data shows that currently, there are approximately 70 million people in China who are chronically infected with the hepatitis B virus (HBV), among which about 20 to 30 million are chronic hepatitis B patients, and the number of newly diagnosed cases continues to grow. There is still a significant unmet treatment need for the vast number of hepatitis B patients. Therefore, the progress of new hepatitis B drugs under research has drawn considerable attention.
 

Recently, there is good news that the Center for Drug Evaluation of China's National Medical Products Administration has announced that GSK's Class 1 new drug, GSK3228836 injection, has received implied permission for a clinical trial, with the indication being "chronic hepatitis B."
 

According to reports, current treatment options for chronic hepatitis B include nucleoside/nucleotide analogs, but these drugs can only suppress the virus rather than eliminate it, so patients need to take them for life.
 

GSK3228836, developed in collaboration by GSK and Ionis, is an investigational antisense oligonucleotide (ASO) designed to specifically target the messenger RNA (mRNA) used by the hepatitis B virus to produce viral antigens (pathogenic proteins) in liver cells (hepatocytes). This drug utilizes advanced antisense oligonucleotide technology to inhibit the virus and viral proteins, with the aim of evaluating functional cure.
 

On August 9, 2021, GSK3228836 was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) in China, significantly reducing the clinical research time. The breakthrough therapy designation refers to the expedited development of treatments for certain serious conditions where the investigational drug has demonstrated substantial advantages in safety or efficacy over current therapies in clinical trials.
 

According to reports, in the published Phase 2 study of GSK3228836, the product demonstrated good pharmacokinetics (PK) and antiviral effects.
 

The trial participants in this study were chronic hepatitis B patients, both hepatitis B e-antigen positive and negative, who had either received nucleoside treatment for over 12 months with HBV DNA suppressed (<20 IU/mL) or were untreated with HBV DNA ≥ 2000 IU/mL. Researchers administered 300 mg of GSK836 or a placebo via subcutaneous injection on Days 1, 4, 8, 11, 15, and 22. By Day 29, participants who had previously received nucleoside treatment showed a 2.5 log reduction in hepatitis B surface antigen (HBsAg) after receiving GSK836, compared to only a 0.008 log reduction in the placebo group. In treatment-naive participants, a 1.556 log reduction in HBsAg was observed.
 

In this Phase 2 study, GSK836 demonstrated acceptable safety and tolerability in most treatment-naïve subjects and those previously treated with nucleoside analogs. Additionally, researchers observed significant ALT flares reaching peaks of 781 U/L and 15X ULN in two subjects following GSK836 treatment.
 

The industry pointed out that, based on the results of GSK836's Phase 2a study, it has made positive progress in terms of efficacy and safety. As this new drug has received implied permission for clinical trials, upon successful market entry, it will accelerate the resolution of unmet clinical drug needs in the field of chronic hepatitis B.
 

Besides GSK3228836, there have been numerous advancements in global hepatitis B new drugs this year. For instance, the entry inhibitor hzVSF, the capsid inhibitor EDP-514, and the therapeutic vaccine AIC 649 have entered Phase II clinical trials; the capsid inhibitor ABI-H3733 has moved into Phase Ib clinical trials, among others.
 

 

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