Vir Biotechnology, Inc. (NASDAQ: VIR) has released preliminary data from its phase 2 Solstice hepatitis delta clinical trial, showcasing the effectiveness of tobevibart monotherapy and combination therapy with elebsiran in treating people living with chronic hepatitis delta. The data was presented in a press release on June 5, 2024.
The preliminary data from the trial showed high rates of virologic response at weeks 12 and 24, durable virologic response through 48 weeks, and high rates of ALT normalization for participants treated with tobevibart alone or in combination with elebsiran. Notably, the majority of adverse events were grade 1-2 and transient in nature, with no reported serious adverse events, ALT flares, or grade 2 or higher elevations in liver function tests.
The preliminary data from participants in the trial revealed the following key findings:
- For participants who received 12 weeks of either tobevibart or elebsiran monotherapy and then rolled over into combination therapy, 100% achieved HDV RNA < limit of detection (LOD) or ≥ 2 log10 IU/mL decrease from baseline, with 50% achieving ALT normalization and the combined endpoint.
- In the preliminary de novo combination of tobevibart + elebsiran (monthly dosing) data, 100% of participants achieved HDV RNA < LOD or ≥ 2 log10 IU/mL decrease from baseline at week 12, with 44% achieving ALT normalization. At week 24, 100% achieved HDV RNA < LOD or ≥ 2 log10 IU/mL decrease from baseline, with 64% achieving ALT normalization.
- Preliminary tobevibart monotherapy (twice monthly dosing) data demonstrated that at week 12, 73% of participants achieved HDV RNA < LOD or ≥ 2 log10 IU/mL decrease from baseline, with 54% achieving ALT normalization. At week 24, 55% achieved HDV RNA < LOD or ≥ 2 log10 IU/mL decrease from baseline, with 64% achieving ALT normalization.
The company also noted that the majority of adverse events were grade 1-2 and transient in nature, with no serious adverse events, ALT flares, or grade 2 or higher elevations in liver function tests observed.
The company stated that the preliminary data from the phase 2 hepatitis delta trial provides compelling evidence that both tobevibart and elebsiran in combination or tobevibart as monotherapy could represent a transformative treatment option for individuals living with chronic hepatitis delta.
The company is on track to report additional 24-week treatment data for all approximately 60 Solstice participants in the fourth quarter of 2024. The company expressed its commitment to working closely with regulatory authorities to determine the next steps to bring these promising candidates to patients in need as expeditiously as possible.
The Solstice trial (NCT05461170) is evaluating the safety, tolerability, and efficacy of tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta. Approximately 50% of participants have compensated cirrhosis.
The preliminary data from the trial has been recognized as a significant step forward in addressing the critical unmet medical need for effective and convenient therapies for chronic hepatitis delta. The company is set to present more detailed data from the trial at the European Association for the Study of the Liver (EASL) Congress 2024.
For more detailed information, the company will be hosting an investor conference call on June 5, 2024, to discuss the data. The EASL oral scientific presentation will also be made available under events & presentations in the investors section of the Vir website following the presentation on June 8th. Following these announcements, the company's shares moved 18.1%, and are now trading at a price of $12.49. For the full picture, make sure to review Vir Biotechnology's 8-K report.
