The U.S. Food and Drug Administration (FDA) has granted fast-track designation to pevifoscorvir sodium, Aligos Therapeutics‘ oral therapy candidate for chronic hepatitis B, which is now being tested in patients in a global clinical trial.

Fast-track status is intended to expedite the clinical development and regulatory review of treatments with the potential to address an unmet medical need for serious conditions. It allows more frequent communication with the FDA and, if criteria are met, may qualify the candidate for additional programs, including rolling review and priority review, which provide faster routes to approval.

“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,” said Lawrence Blatt, PhD, chairman, president, and CEO at Aligos, in a company press release.

Phase 2 B-SUPREME Clinical Trial Updates

Aligos also announced data from the first prespecified interim analysis of the global Phase 2 B-SUPREME clinical trial (NCT06963710). The study is comparing pevifoscorvir sodium to the standard antiviral tenofovir disoproxil fumarate (sold as Viread, with generics available) in adults with chronic hepatitis B, regardless of their HBeAg status. HBeAg is a hepatitis B virus (HBV) protein that indicates the virus is replicating in the body.

Pevifoscorvir sodium, previously known as ALG-000184, has been well tolerated to date, with no safety concerns, according to the company. B-SUPREME’s independent Data Safety Monitoring Review Board (DSMB) has also recommended that the trial continue after futility criteria were not met, meaning that data so far suggest the treatment has the potential to be effective.

Next Steps for Enrollment and Data

Still, the DSMB recommended increasing the number of patients in the HBeAg-negative group from the 74 currently enrolled to 100 to boost the trial’s ability to demonstrate a statistically significant effect. The company remains blinded to participant-level data.

“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 [goal],” Blatt said. “We believe we can enroll the necessary study participants in the coming months, with topline data on track for 2027.”