Aligos Therapeutics Announces Interim Results and FDA Fast Track Designation for Hepatitis B Drug

The company's Phase 2 study of pevifoscorvir sodium continues with an increased sample size, and the FDA grants Fast Track status to the potential best-in-class treatment.

Apr. 14, 2026 at 8:30pm

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A highly detailed, translucent X-ray image showing the intricate molecular structure of a hepatitis B virus particle, with its various components visible as glowing lines and shapes against a dark background.An X-ray view of the complex inner workings of the hepatitis B virus, highlighting the need for advanced treatments to combat this serious liver disease.South San Francisco Today

Aligos Therapeutics announced the first interim analysis results of its Phase 2 B-SUPREME study of pevifoscorvir sodium in participants with chronic hepatitis B virus (HBV) infection. The independent Data Safety Monitoring Review Board recommended continuing the study with an increased sample size for the HBeAg- cohort. Additionally, the FDA has granted Fast Track Designation to pevifoscorvir sodium, a capsid assembly modulator being investigated for the treatment of chronic HBV.

Why it matters

Chronic HBV is a serious, life-threatening condition that affects millions globally and can lead to severe liver disease and cancer. The FDA's Fast Track status for pevifoscorvir sodium could accelerate its development and review, potentially providing a new treatment option for patients with this unmet medical need.

The details

The Phase 2 B-SUPREME study is evaluating the safety and efficacy of pevifoscorvir sodium monotherapy compared to tenofovir disoproxil fumarate in approximately 200 untreated HBeAg+ and HBeAg- adults with chronic HBV. The first interim analysis, conducted after 60% of HBeAg- participants reached Week 12, found the study drugs were well-tolerated with no safety concerns. The DSMB recommended increasing the HBeAg- cohort sample size from 74 to 100 participants to optimize statistical powering, though the futility criteria was not met.

  • The first interim analysis was performed in April 2026.
  • Completion of enrollment in the HBeAg- cohort is expected in the second half of 2026.
  • Topline data from the B-SUPREME study remains on track for 2027.

The players

Aligos Therapeutics

A clinical stage biopharmaceutical company focused on developing therapies for liver and viral diseases, including chronic hepatitis B.

Lawrence Blatt, Ph.D., M.B.A.

Chairman, President, and Chief Executive Officer at Aligos Therapeutics.

Pevifoscorvir sodium

A potent potential best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed by Aligos for chronic hepatitis B virus (HBV) infection.

FDA

The United States Food and Drug Administration, which has granted Fast Track Designation to pevifoscorvir sodium.

Data Safety Monitoring Review Board (DSMB)

An independent group that reviewed the interim analysis data and recommended increasing the sample size for the HBeAg- cohort in the B-SUPREME study.

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What they’re saying

“We are encouraged by this recommendation from the DSMB to increase the sample size in order to increase the probability for success of the study's primary endpoint.”

— Lawrence Blatt, Chairman, President, and Chief Executive Officer at Aligos Therapeutics

“Aligos' mission since its founding has been to improve outcomes for patients with unmet needs in liver and viral diseases and being granted Fast Track Designation for pevifoscorvir sodium is the next step in our journey to make this a reality.”

— Lawrence Blatt, Chairman, President, and Chief Executive Officer at Aligos Therapeutics

What’s next

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The takeaway

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