Tobevibart Monotherapy and Combination Therapy with Elebsiran Achieved High Virologic Response and ALT Normalization in People Living with the Hepatitis Delta Virus After 12 and 24 Weeks of Treatment

– Preliminary Phase 2 SOLSTICE trial data reinforce the potential of both regimens to be transformative treatments in an area of high unmet medical need –

– Conference call scheduled for June 5, 2024, at 6:00 a.m. ET / 12:00 p.m. CEST –

SAN FRANCISCO--(BUSINESS WIRE)-- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced new preliminary data from its Phase 2 SOLSTICE hepatitis delta clinical trial evaluating tobevibart, an investigational monoclonal antibody, and elebsiran, an investigational small interfering ribonucleic acid, for the treatment of people living with chronic hepatitis delta. Preliminary data from the Phase 2 trial show treatment with tobevibart alone or in combination with elebsiran was generally well tolerated and participants achieved high rates of virologic response at weeks 12 and 24, durable virologic response through 48 weeks, and high rates of ALT normalization.

The Company will host an investor conference call on June 5 at 6:00 a.m. ET / 12:00 p.m. CEST to discuss these data. Originally accepted as a late-breaker poster, these data will be presented in more detail in an oral presentation on June 8 at the European Association for the Study of the Liver, EASL™ Congress 2024.

Preliminary data from the six participants reported on at the 2023 American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® demonstrated sustained virologic response:

• These participants received 12 weeks of either tobevibart or elebsiran monotherapy and then rolled over into combination therapy. All 6 participants remain on treatment. At the time of the analysis, 5 out of the 6 participants had reached 48 weeks of combination therapy and 1 had reached 40 weeks of combination therapy.
  • All 6 participants showed sustained virologic response at time of last visit
  • 100% (6 of 6) achieved HDV RNA < limit of detection (LOD) or ≥ 2 log10 IU/mL decrease from baseline
  • 50% (3 of 6) achieved ALT normalization
  • 50% (3 of 6) achieved the combined endpoint*
  • Furthermore, 100% (6 of 6) achieved HDV RNA < the lower limit of quantification (LLOQ), 100% (6 of 6) achieved HDV RNA < LOD, and 83% (5 of 6) achieved HDV RNA target not detected (TND)
• The majority of adverse events were Grade 1-2 and transient in nature with no reported serious adverse events, no ALT flares and no Grade 2 or higher elevations in liver function tests (LFTs) were observed.

Preliminary de novo combination of tobevibart + elebsiran (monthly dosing) data demonstrated rapid and high rates of virologic suppression and ALT normalization:

• Week 12: Among 27 participants
  • 100% (27 of 27) achieved HDV RNA < LOD or ≥ 2 log10 IU/mL decrease from baseline
  • 44% (12 of 27) achieved ALT normalization
  • 44% (12 of 27) achieved the combined endpoint*
  • Furthermore, 52% (14 of 27) achieved HDV RNA < LLOQ, 37% (10 of 27) achieved HDV RNA < LOD, and 15% (4 of 27) achieved HDV RNA TND
• Week 24: Among 11 participants
  • 100% (11 of 11) achieved HDV RNA < LOD or ≥ 2 log10 IU/mL decrease from baseline
  • 64% (7 of 11) achieved ALT normalization
  • 64% (7 of 11) achieved the combined endpoint*
  • Furthermore, 100% (11/11) achieved HDV RNA < LLOQ, 91% (10 of 11) achieved HDV RNA < LOD, and 55% (6 of 11) achieved HDV RNA TND
• Similar rates of virologic suppression and ALT normalization were observed in participants who are non-cirrhotic (n=6) and those with compensated cirrhosis (CPT-A, n=5).
• The majority of adverse events were Grade 1-2 and transient in nature with no treatment-related serious adverse events, no ALT flares and no Grade 2 or higher elevations in LFTs were observed.

Preliminary tobevibart monotherapy (twice monthly dosing) data demonstrated high rates of virologic suppression and ALT normalization:

• Week 12: Among 26 participants
  • 73% (19 of 26) achieved HDV RNA < LOD or ≥ 2 log10 IU/mL decrease from baseline
  • 54% (14 of 26) achieved ALT normalization
  • 38% (10 of 26) achieved the combined endpoint*
  • Furthermore, 27% (7 of 26) achieved HDV RNA < LLOQ, 19% (5 of 26) achieved HDV RNA < LOD, and 8% (2 of 26) achieved HDV RNA TND
• Week 24: Among 11 participants
  • 55% (6 of 11) achieved HDV RNA < LOD or ≥ 2 log10 IU/mL decrease from baseline
  • 64% (7 of 11) achieved ALT normalization
  • 55% (6 of 11) achieved the combined endpoint*
  • Furthermore, 55% (6 of 11) achieved HDV RNA < LLOQ, 46% (5 of 11) achieved HDV RNA