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Hepatitis Delta Treatment Combination Receives FDA IND Clearance and Fast Track Designation Following Positive Phase II Results

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The FDA has cleared Vir Biotechnology’s investigational new drug (IND) application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection. Tobevibart, an investigational monoclonal antibody, and elebsiran, an investigational small interfering ribonucleic acid, are currently being evaluated in the Phase II SOLSTICE hepatitis delta clinical trial. Vir expects to report 24-week treatment data in the fourth quarter.1

The Phase II SOLSTICE clinical trial (NCT05461170) has two cohorts. One is evaluating the combination of tobevibart and elebsiran dosed every 4 weeks with a second cohort evaluating tobevibart monotherapy every 2 weeks. Approximately 50% of participants have compensated cirrhosis.

“The IND clearance and Fast Track designation from the FDA, along with the encouraging preliminary data from our Phase II hepatitis delta trial, underscore the potential of tobevibart and elebsiran to transform the treatment landscape for people living with this severe and life-threatening disease,” Marianne De Backer, MSc, PhD, MBA, chief executive officer, Vir said in a press release. “We are committed to working closely with health authorities to bring this potential groundbreaking treatment to patients as quickly as possible, addressing a critical unmet medical need.”

Hepatitis D is an inflammation of the liver caused by the hepatitis D virus (HDV). It requires hepatitis B virus (HBV) for its replication. According to the World Health Organization, HDV affects globally nearly 5% of people who have a chronic infection with HBV.2

Earlier in June, Vir shared the Phase II SOLSTICE data. Preliminary results showed 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.3

“As the most severe form of viral hepatitis, chronic hepatitis delta poses a significant threat to millions worldwide and often leads to life-threatening complications such as cirrhosis and liver cancer. Despite the urgent need for effective and convenient therapies, the options for patients remain limited,” Tarik Asselah, MD, PhD, professor of hepatology at the Hôpital Beaujon, APHP, Clichy, France, and at the University of Paris, and head of viral hepatitis at INSERM UMR1149, France said in an earlier press release. “The impressive reduction in HDV RNA observed in the preliminary SOLSTICE trial data surpasses any previous therapy reported to date and highlights the promise of tobevibart and elebsiran in addressing this critical unmet need.”

De Backer added: “The preliminary data from our Phase II hepatitis delta trial provide compelling evidence that either tobevibart and elebsiran in combination or tobevibart as monotherapy could represent a transformative treatment option for individuals living with this devastating disease. Recognizing the critical need for improved treatment options, we are committed to working closely with regulatory authorities to determine the next steps to bring these promising candidates to patients in need as expeditiously as possible.”

Additionally, Vir is working to expedite the initiation of its next clinical trial, ECLIPSE. The trial is set to be an open-label, randomized, controlled study evaluating the safety and efficacy of a monthly-administered subcutaneous injection of tobevibart and elebsiran using the current standard of care therapy as a comparator.

References

1. Vir Biotechnology Receives FDA IND Clearance and Fast Track Designation for Tobevibart and Elebsiran for the Treatment of Chronic Hepatitis Delta Infection. News release. Vir Biotechnology. June 26, 2024. Accessed July 2, 2024. https://www.businesswire.com/news/home/20240626614229/en/Vir-Biotechnology-Receives-FDA-IND-Clearance-and-Fast-Track-Designation-for-Tobevibart-and-Elebsiran-for-the-Treatment-of-Chronic-Hepatitis-Delta-Infection

2. Hepatitis D. World Health Organization. July 20, 2023. Accessed July 2, 2024. https://www.who.int/news-room/fact-sheets/detail/hepatitis-d

3. 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. News release. Vir Biotechnology. June 5, 2024. Accessed July 2, 2024. https://investors.vir.bio/news/news-details/2024/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/default.aspx