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     377  0 Kommentare Treatment with Arbutus’ Imdusiran and VTP-300 Achieves Statistical Significance in Lowering HBsAg Levels

    Data highlighted in oral presentation at the European Association for the Study of the Liver (EASL) Congress

    WARMISTER, Pa., June 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, announced new preliminary end-of-treatment (EOT) data from the Phase 2a clinical trial (IM-PROVE II, AB-729-202) in patients receiving ongoing standard-of-care nucleos(t)ide analogue (NA) therapy indicating that treatment with imdusiran, Arbutus’ RNAi therapeutic, followed by Barinthus Biotherapeutic's T-cell stimulating immunotherapeutic, VTP-300, was generally safe, well-tolerated and led to maintenance of lower HBsAg levels during the post-treatment follow-up period in patients with cHBV. The data were presented today by Dr. Kosh Agarwal, MD, Consultant Hepatologist and Transplant Physician at the Institute of Liver Studies at King’s College Hospital, London, during a session focused on new treatments for viral hepatitis B at the European Association for the Study of the Liver (EASL) Congress.  

    Dr. Agarwal presented the following data from 38 of 40 patients that were on stable NA therapy throughout the treatment period, received imdusiran (60mg every 8 weeks) for 24 weeks and were then randomized to receive either VTP-300 (treatment arm) or placebo at Weeks 26 and 30:

    • Robust reductions of HBsAg were seen during the imdusiran lead-in period (-1.8 log10 by week 26) with 95% of patients achieving HBsAg <100 IU/mL before undergoing dosing in the treatment or placebo arm.
    • At 24-weeks post-EOT, there was a significant difference (p<0.05) in HBsAg levels between the treatment arm (n=5) and placebo (n=6).
    • 94% of patients (n=18/19) in the treatment arm achieved HBsAg levels of <100 IU/mL and 36% (n=7/19) had <10 IU/mL at EOT (Week 48) compared to 84% (n=16/19) and 21% (n=4/19), respectively in the placebo arm.
      • Similarly, at 24-weeks post-EOT (Week 72), the treatment arm had lower HBsAg levels with 80% of patients (n= 4/5) at <100 IU/mL and 60% (n=3/5) at <10 IU/mL compared to the placebo arm with 16% (n=1/6) and 0% (n=0/6), respectively.
    • 84% of patients (n=16/19) in the treatment arm met the NA therapy discontinuation criteria and stopped NA treatment after Week 48 compared to 53% (n=10/19) in the placebo arm. One patient in the treatment arm achieved undetectable HBsAg and another had a >1.5 log10 decline between the last two visits during the NA-therapy discontinuation follow-up period.
    • Treatment with imdusiran and VTP-300 was generally safe and well-tolerated. There were no Serious Adverse Events (SAEs), Grade 3 or 4 Adverse Events (AEs) or discontinuations due to treatment. The most common treatment-related AEs in two or more patients were injection site-related (both imdusiran and VTP-300) and transient ALT increases (imdusiran).

    Dr. Agarwal commented, “These data show that adding imdusiran and VTP-300 to ongoing NA therapy in cHBV patients meaningfully reduces HBsAg after the end of the treatment period. I am impressed with the number of patients that qualified to stop NA therapy in the VTP-300 group and the clear separation in HBsAg levels between the treatment arm and placebo at Week 72.”

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    Treatment with Arbutus’ Imdusiran and VTP-300 Achieves Statistical Significance in Lowering HBsAg Levels Data highlighted in oral presentation at the European Association for the Study of the Liver (EASL) Congress WARMISTER, Pa., June 06, 2024 (GLOBE NEWSWIRE) - Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a …