Key Takeaways
- Vir Biotechnology has commenced the Phase 3 ECLIPSE program to test the combination of tobevibart and elebsiran in patients with chronic hepatitis delta (CHD).
- The trials aim to provide critical data for regulatory submissions, as there are currently no approved treatments for CHD in the U.S.
- The FDA has granted Breakthrough and Fast Track designations to the combination therapy, indicating its potential significance for patient care.
Vir Biotechnology, Inc. announced today that the first patient has been enrolled in its Phase 3 ECLIPSE registrational program. This program will evaluate the safety and efficacy of tobevibart in combination with elebsiran for treating chronic hepatitis delta (CHD). ECLIPSE consists of three trials: ECLIPSE 1 aims to assess this combination against deferred treatment, while ECLIPSE 2 will study its efficacy in patients who have not responded to existing therapies. ECLIPSE 3, a Phase 2b trial, will generate supporting data for key European market access.
CHD is a severe inflammatory liver disease caused by the hepatitis delta virus, often leading to cirrhosis or liver failure within five years. Effective treatment options are urgently needed, with no approved therapies available in the U.S. and limited options in the European Union. The combination of tobevibart and elebsiran targets the viral lifecycle through multiple mechanisms, potentially offering significant benefits in viral suppression.
Clinical data from Vir’s SOLSTICE Phase 2 trial indicated that this combination therapy could effectively reduce the hepatitis delta virus to undetectable levels. Marianne De Backer, CEO of Vir Biotechnology, highlighted the significance of the ECLIPSE program, calling it a “pivotal moment” for CHD patients.
Chari A. Cohen, President of the Hepatitis B Foundation, expressed optimism about the new therapies being explored, indicating that they might provide options for patients facing a bleak prognosis.
The ECLIPSE program has garnered attention from regulatory authorities, with the FDA awarding Breakthrough and Fast Track designations and the European Medicines Agency granting Priority Medicines (PRIME) and orphan drug status to the therapy. These accelerations underscore the potential of tobevibart and elebsiran as a much-needed treatment for CHD.
ECLIPSE 1 plans to enroll 120 participants in the U.S. or regions with limited access to existing treatments. Participants will be randomized to receive the new combination therapy or deferred treatment involving nucleoside reverse transcriptase inhibitors. The primary endpoint focuses on achieving undetectable levels of HDV RNA and normal ALT levels by week 48.
Tobevibart is a monoclonal antibody that blocks the entry of hepatitis B and delta viruses into liver cells while reducing circulating viral particles. Elebsiran, developed by Alnylam Pharmaceuticals, is a small interfering RNA designed to degrade hepatitis B virus RNA transcripts. Both treatments are currently under clinical development for chronic hepatitis delta and chronic hepatitis B.
Vir Biotechnology is committed to advancing innovative therapies for serious infectious diseases and cancer, with ongoing efforts to transform the treatment landscape for chronic hepatitis delta.
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