Aligos Therapeutics has initiated dosing in the randomised Phase II B-SUPREME trial of its oral therapy, ALG-000184, in people with chronic hepatitis B virus (HBV) infection.
The double-blind, multi-centre, active-controlled trial aims to compare the efficacy and safety of the therapy as a single agent with tenofovir disoproxil fumarate over a period of 48 weeks in around 200 adult participants.
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These subjects have not received prior treatment for HBV, including both HBeAg-positive and HBeAg-negative individuals.
The study’s primary goal is to achieve HBV DNA levels below the lower limit of quantitation (LLOQ) with different endpoints for HBeAg-positive and HBeAg-negative subjects.
Alongside the primary efficacy measures, the trial will also monitor the therapy’s pharmacokinetics, safety and other exploratory and secondary biomarkers, which include the minimisation of HBV antigens and other infection markers.
The Phase II B-SUPREME trial is projected to yield interim data in 2026, with topline results expected in 2027.
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By GlobalDataAligos Therapeutics CEO, chairman and president Lawrence Blatt said: “Dosing the first subjects in our Phase II B-SUPREME study is an important milestone for Aligos.
“We are pleased by the engagement of the clinicians and subjects, as they recognise 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.”
ALG-000184 is the result of an initial intellectual property licensed from Emory University’s Dr Raymond Schinazi laboratory and has been further enhanced by Aligos.
Previous Phase I trials have shown that the therapy was tolerated well by participants, without any safety concerns identified.
The therapy displayed linear pharmacokinetics and exhibited significant antiviral activity.
Chronic HBV is a viral infection that mainly impacts the liver.
Last year, the company announced positive topline outcomes from the Phase IIa HERALD trial of ALG-055009, a thyroid hormone receptor beta agonist to treat metabolic-dysfunction-associated steatohepatitis (MASH).
