Imdusiran data from IM-PROVE I and IM-PROVE II Phase 2a clinical trials to be presented at upcoming AASLD - The Liver Meeting 2024
Multiple-ascending doses of AB-101 in healthy subjects in the Phase 1a/1b clinical trial were generally safe and well-tolerated with evidence of receptor occupancy
Now dosing cHBV patients with AB-101 in Part 3 of the Phase 1a/1b clinical trial
Cash runway into the fourth quarter of 2026Conference Call and Webcast Today at 8:45 AM ET
WARMINSTER, Pa., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, today reports third quarter 2024 financial results and provides a corporate update.
“We are making significant progress in advancing the development of imdusiran to bring hope to millions of cHBV patients globally,” said Michael J. McElhaugh, Interim President and Chief Executive Officer of Arbutus Biopharma. “In June, we shared promising data from our IM-PROVE I Phase 2a clinical trial, showing that some patients treated with imdusiran and interferon were trending towards a functional cure. We look forward to presenting follow-up data from this trial, as well as end-of-treatment data from patients that received nivolumab in addition to imdusiran and VTP-300 in our IM-PROVE II Phase 2a trial, at the upcoming AASLD meeting. Assuming continued positive data, and with a projected cash runway extending into the fourth quarter of 2026, we are well-positioned to advance imdusiran into a Phase 2b clinical trial as a cornerstone in a treatment regimen aimed at functionally curing cHBV.”
Mr. McElhaugh continued, “Our proprietary oral PD-L1 checkpoint inhibitor, AB-101, is progressing well, as we continue to see dose-dependent receptor occupancy and have now advanced into dosing cHBV patients in our Phase 1a/1b clinical trial. We look forward to providing updates as this trial progresses.”
Clinical Development Update
Imdusiran (AB-729, RNAi Therapeutic)
- End-of-treatment data from the IM-PROVE I Phase 2a clinical trial evaluating the safety, tolerability and antiviral activity of the combination of imdusiran (4 or 6 doses over 24 or 48 weeks, respectively), nucleos(t)ide analogue (NA) therapy and a short course of pegylated interferon alfa-2a (IFN, 12 or 24 weeks) in patients with cHBV was presented at the EASL Congress in June. The data showed that 33.3% (n=4/12) of patients in Cohort A1 receiving 48 weeks (6 doses) of imdusiran combined with 24 weeks of IFN and NA therapy achieved HBsAg loss at the end-of-treatment that was maintained in 100% of these patients 24 weeks after completing imdusiran and IFN treatment. HBsAg loss was achieved and maintained in 67% of those patients with HBsAg less than 1000 IU/mL at baseline. A total of six patients from Cohort A1 (n=4) and Cohort A2 (n=2) seroconverted with HBsAg loss. At the time the data was reported, all six of those patients had stopped all therapy, with two of those patients reaching 12 weeks off all therapy with sustained HBsAg and HBV DNA loss. The combination of imdusiran and IFN in this clinical trial was generally safe and well-tolerated. The Company will present a late-breaker poster with additional follow-up data at the upcoming AASLD-The Liver Meeting 2024 later this month.
- End-of treatment data from the IM-PROVE II Phase 2a clinical trial evaluating the safety and immunogenicity of imdusiran, NA therapy and Barinthus Bio’s VTP-300, an HBV antigen-specific immunotherapy was presented at the EASL Congress in June. The data showed that the combination of imdusiran and VTP-300 was generally safe and well-tolerated. At 24-weeks post-end of treatment, statistical significance (p