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# GSK Hepatitis B Drug Hits Trial Marks
- URL: https://www.fdaweb.com/gsk-hepatitis-b-drug-hits-trial-marks/
- Published: 2026-01-08T12:00:00.000Z
- Updated: 2026-09-14T15:30:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160455

GSK says its investigational bepirovirsen met the primary endpoints in the B-Well 1 and B-Well 2 pivotal Phase 3 trials evaluating it as a treatment for chronic hepatitis B in over 1,800 patients. A company [statement](https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-results-from-b-well-1-and-b-well-2-phase-iii-trials-for-bepirovirsen-a-potential-first-in-class-treatment-for-chronic-hepatitis-b/?ref=fdaweb.com) says GSK plans global regulatory filings from the first quarter of 2026.

“The B-Well trials met their primary endpoint, and bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate,” the statement says. “Functional cure rates were significantly higher with bepirovirsen plus standard of care (nucleos(t)ide analogues) compared with standard of care alone…. The trials demonstrated an acceptable safety and tolerability profile consistent with what was reported in other studies.”

Bepirovirsen is described as a triple-action investigational antisense oligonucleotide designed to recognize and orchestrate the destruction of the genetic components (RNA) of the hepatitis B virus that can lead to chronic disease, potentially allowing a person’s immune system to regain control. It inhibits the replication of viral DNA in the body, suppresses the level of hepatitis B surface antigen in the blood, and stimulates the immune system to increase the chances of a durable and sustained response, GSK says. The drug has received a fast-track designation from FDA.