China-based Brii Biosciences Ltd (HKG: 2137) has announced topline cohort-level unblinded Week 36 data from an interim analysis of a randomized, placebo-controlled, and double-blinded Phase II study of BRII-179 (VBI-2601), a first-in-class Pre-S1/Pre-S2/S therapeutic vaccine, used in combination with pegylated interferon-alpha (PEG-IFNα) for the treatment of chronic hepatitis B virus (HBV) patients.
Interim Analysis Results
The cohort-level unblinded data from the study demonstrated promising results in the intent to treat analysis at Week 24 (end of treatment or EoT), with 26.3% (15 patients) treated with BRII-179/PEG-IFNα achieving HBsAg loss compared to 19.3% (11 patients) with placebo/PEG-IFNα. At Week 36 (12 weeks follow-up), 24.6% (14 patients) treated with BRII-179/PEG-IFNα had HBsAg loss, compared with 14.0% (8 patients) with placebo/PEG-IFNα. In the per protocol analysis at Week 24, 32.6% (15 patients) treated with BRII-179/PEG-IFNα achieved HBsAg loss compared to 21.6% (11 patients) with placebo/PEG-IFNα; at Week 36, 31.8% (14 patients) and 14.9% (7 patients) had HBsAg loss, respectively. Additionally, 9 out of 15 patients in the cohort treated with BRII-179/PEG-IFNα achieved HBsAg seroconversion at EoT (Week 24), versus 1 out of 11 in the cohort treated with PEG-IFNα alone.
Safety and Tolerability
The cohort level unblinded 24 weeks safety data showed that BRII-179/PEG-IFNα treatment was generally safe and tolerated, with adverse events similar to those associated with PEG-IFNα treatment or BRII-179 as previously reported. Follow-up is ongoing to further assess the safety profile and efficacy of the treatment.
Global Rights Expansion
In July 2023, Brii Bio expanded the BRII-179 (VBI-2601) license from VBI Vaccines (NASDAQ: ALNY) to global rights, marking a significant step in the company’s commitment to developing innovative therapies for chronic hepatitis B patients worldwide.-Fineline Info & Tech
