Arbutus Biopharma Corporation (NASDAQ: ABUS) and Antios Therapeutics Inc. have announced the dosing of the first patient in triple combination treatment in chronic hepatitis B virus infection.
Antios’ ATI-2173 and Arbutus’ A-729 to be evaluated in the study
A triple combination of Antios’ proprietary active site polymerase inhibitor nucleotide (ASPIN), ATI-2173, Arbutus’ specialized GalNAc delivered RNAi therapeutic, AB-729, and tenofovir disoproxil fumarate (TDF), a nucleotide reverse transcriptase inhibitor, will be evaluated in the ongoing Antios Phase 2a SAVE-1 (Sustained Anti-Viral Efficacy) clinical trial.
The double-blind, multi-center, combination clinical study will enroll 40 patients, including ten individuals with persistent HBV infection who will be randomly assigned 8:2 to active medications (ATI-2173+AB-729) or placebos. The active medications (ATI-2173+AB-729) will be given in conjunction with 300 mg of tenofovir disoproxil fumarate or placebos. For 90 days, ATI-2173 and tenofovir disoproxil fumarate will be given orally and by injection once daily. On Day 28 and Day 90, AB-729 will be given as a subcutaneous injection. Patients will be monitored for six months after the 90-day therapy period to ensure safe and persistent antiviral responses.
Antios Co-founder and Chief Medical Officer Douglas Mayers stated, “The need for a functional cure for HBV is clear. Current therapies only partially suppress HBV replication and require ongoing treatment, adding to patient burden. By combining AB-729 with ATI-2173 and tenofovir disoproxil fumarate, we hope to reduce hepatitis B surface antigens and sustain HBV DNA suppression while off treatment.”
ATI-2173 is under clinical development for HBV DNA reduction
ATI-2173 is the sole ASPIN under clinical development, and preclinical studies suggest that ATI-2173, alone or in combination with TDF, has the potential to reduce HBV DNA for a long time after therapy, which is unique among authorized nucleos(t)ides and investigational anti-HBV medicines.
Arbutus Chief Development Officer, Dr. Gaston Picchio, commented, “In our common endeavor to find a cure for chronic HBV, we are eager to evaluate the combination of these two unique assets which we expect will allow us to further understand the potential benefits of such combination therapy for patients with chronic HBV.”
