Aligos Therapeutics has initiated patient dosing in its Phase 2 B-SUPREME study evaluating ALG-000184, an investigational oral therapy for chronic hepatitis B virus (HBV) infection. The milestone represents a significant advancement for the clinical-stage biopharmaceutical company's efforts to develop improved treatments for liver and viral diseases.
Study Design and Patient Population
The B-SUPREME study (NCT06963710) is a randomized, double-blind, active-controlled multicenter trial designed to evaluate the safety and efficacy of ALG-000184 monotherapy compared with tenofovir disoproxil fumarate in approximately 200 untreated adult subjects with chronic HBV infection over 48 weeks. The study will include both HBeAg-positive and HBeAg-negative patients who have not received prior treatment for HBV.
The primary endpoint focuses on achieving HBV DNA levels below the lower limit of quantitation (LLOQ), with different endpoints specified for HBeAg-positive and HBeAg-negative subjects. Secondary and exploratory measures will monitor the therapy's pharmacokinetics, safety profile, and other biomarkers, including the minimization of HBV antigens and other infection markers.
Clinical Rationale and Expert Perspective
"Despite available treatments for chronic HBV infection, better therapies are needed to stem the progression to end-stage liver disease and liver cancer," said Nezam Afdhal, MD, DSc, Chief of Gastroenterology, Hepatology, and Nutrition at Beth Israel Deaconess Medical Center and Charlotte & Irving Rabb Distinguished Professor of Medicine at Harvard Medical School. "I am pleased that therapies such as Aligos' ALG-000184 are continuing to progress. The impressive antiviral activity seen in clinical trials to date provides hope for patients in need."
Previous Clinical Results and Development
ALG-000184 originated from intellectual property licensed from Emory University's Dr Raymond Schinazi laboratory and has been further enhanced by Aligos. Previous Phase 1 trials demonstrated that the therapy was well-tolerated by participants, with no safety concerns identified. The compound exhibited linear pharmacokinetics and displayed significant antiviral activity across viral markers of HBV.
Timeline and Company Outlook
The Phase 2 B-SUPREME trial is projected to yield interim data in 2026, with topline results expected in 2027. Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics, expressed confidence in the compound's potential.
"Dosing the first subjects in our Phase 2 B-SUPREME study is an important milestone for Aligos," Blatt said. "We are pleased by the engagement of the clinicians and subjects, as they recognize the need for improved treatment regimens for chronic HBV infection. We believe that ALG-000184 has first/best-in-class potential based on the exciting data seen across viral markers of HBV to date. We look forward to continuing to advance ALG-000184 for patients in need of better outcomes."
