GSK Reaches ‘First Base’ In Hep B Functional Cure But Has More To Prove

9% Disease Free After Phase II Study

GSK is the first to raise the functional cure rate with its antisense drug, Phase II data suggest, but the company is looking for ways to boost responses across hepatitis B patients in its Phase III study.

Hepatitis B virus
Hepatitis B has so far proven very difficult to suppress - but GSK is hoping to achieve a functional cure for more patients in its Phase III study • Source: Shutterstock

Recent weeks have seen a flurry of Phase III trial readouts from GSK, ranging from a definite ‘win’ (for its RSV vaccine) to a clear failure (with myeloma therapy Blenrep) in the company’s efforts to bring a new generation of blockbusters to market. The firm has now added to this with Phase II results showing a small number of patients have achieved a functional cure when treated with its chronic hepatitis B (CHB) candidate bepirovirsen. (Also see "GSK’s Blenrep Hit By Trial Failure, Raising Questions About Its Future In The Myeloma Market" - Scrip, 7 November, 2022.) 

The data might not be a clear win just yet, but do set up GSK to move in to Phase...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

ESMO 25: Tolerability Raised As Exelixis STELLAR-303 Study Still Needs To Mature

 

Exelixis’s novel kinase inhibitor zanzalintinib has shown promise in a metastatic colorectal cancer population but some experts want to see more data before passing judgement on whether it can become a new chemotherapy-free treatment option for these patients.

Sanofi’s Inhibrx-Acquired Rare Disease Therapy Clears Phase II Hurdle

 
• By 

Efdoralprin alfa, which was acquired through Inhibrx, has met the endpoints of a Phase II trial for alpha-1 antitrypsin deficiency.

How To Score A Win With Real-World Evidence In India

 
• By 

Bharat Serums showed it’s possible to score a regulatory win with real-world evidence (RWE) studies in India when it ran one leading to a label expansion for its mAb trinbelimab. As cell and gene therapies and rare disease drugs gain currency, sponsors could look at takeaways from the RhYTHM study.

Summit Presses Ahead With Ivonescimab Filing Despite Approval Doubts

 

Frontrunner believes it can gain a first approval in EGFR+ lung cancer, even though the FDA recently raised the bar on overall survival.

More from R&D

China’s Next Wave Is First-In-Class Innovation

 

Drug development in China was a discussion topic at the BioFuture conference as the country’s R&D investments begin to deliver first-in-class medicines.

Neuphoria To Look At Strategic Options After BNC210 Fails In Social Anxiety

 

Neuphoria said that its Phase III trial of BNC210 in social anxiety disorder did not meet the primary or secondary endpoints, but its PTSD program will continue.

ESMO 25: Ovarian Cancer Data Validates Tubulis ADC Platform

 
• By 

Positive first-in-human data for TUB-040 represent "a momentous milestone" for the German biotech, according to its CEO Dominik Schumacher.