Arbutus Biopharma Corp (NASDAQ: ABUS) and Vaccitech PLC – ADR (NASDAQ: VACC) have entered into a partnership to carry out a clinical trial. As part of the agreement, the companies will implement therapeutic combinations to treat patients suffering from chronic hepatitis B virus (HBV) infection (CHB). Additionally, patients who are already receiving standard-of-care nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy are part of the trial.
Chief Development Officer of Arbutus Biopharma Corp comments on the clinical trials
“Based on the positive clinical results we have seen in our ongoing Phase 1a/1b clinical trial for AB-729, including recent data demonstrating increased HBV-specific immune responses, we believe AB-729 has the potential to become a cornerstone therapeutic in multiple future HBV combination regimens,” stated Gaston Picchio, Chief Development Officer at Arbutus Biopharma Corp. “We are looking forward to initiating this proof-of-concept Phase 2a clinical trial, which will allow us to evaluate the combination of two promising clinical candidates with potential complimentary mechanisms of action. We believe combining AB-729, which is designed to reduce HBsAg resulting in increased HBV immune responses with VTP-300, an immunotherapeutic designed to elicit an HBV specific immune response, may offer patients with CHB a much needed and durable functional cure.”
Here’s what the Phase 2a clinical trial will do
Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus Biopharma Corp’s proprietary GalNAc delivered RNAi therapeutic AB-729, followed by Vaccitech PLC – ADR’s proprietary immunotherapeutic, VTP-300, in NrtI-suppressed subjects with CHB. Additionally, it has come to light that the Phase 2a clinical trial will be implemented in the second half of this year. Arbutus will manage it. A joint development committee including representatives from Arbutus Biopharma Corp and Vaccitech PLC – ADR will oversee the clinical trial.
Costs that are involved in the clinical trial will be split among the two companies. Regulatory approval for the trial is pending. The trial is expected to enroll 40 NrtI-suppressed, Hepatitis B e-antigen negative or positive, non-cirrhotic CHB subjects. Subjects are expected to receive AB-729 + NrtI for 24 weeks.
In the 24th week of the trial, subjects will be randomized 1:1 to receive either NrtI + VTP-300 or NrtI + VTP-300 sham. Concurrently, in the 48th week, the subjects involved in the trial will be analyzed if they are eligible to discontinue all treatments or remain on their NrtI only.