Vir gives positive update on hepatitis delta combo, monotherapy

05 Jun 2024
firstwordpharma.com
Phase 2Clinical ResultsiRNA
According to new follow-up data, Vir Biotechnology’s combination of tobevibart and elebsiran kept 100% of chronic hepatitis delta patients virus-free, whilst also continuing to improve liver function, as seen by the rate of ALT normalisation. The 12- and 24-week results from the Phase II SOLSTICE trial were presented at the European Association for the Study of the Liver (EASL) congress.
For the combination, the rate of virologic response was 100% in 27 patients at week 12, as well as in the 11 participants who completed the study through week 24. Vir added that the rates of ALT normalisation in the two groups at those same timepoints were 44% and 64%, respectively.
Ahead of the read-out, Barclays analysts said they would be looking for the viral response rate to be maintained at around 100%, with an improving ALT normalisation rate of about 60%.
Upbeat monotherapy data
Data also showed that 73% of patients on tobevibart monotherapy achieved a virologic response at 12 weeks, while it was 55% after 24 weeks. Further, the rate of ALT normalisation in this arm of the study rose from 54% at 12 weeks to 64% after 24 weeks.
“The preliminary data…provide compelling evidence that either tobevibart and elebsiran in combination or tobevibart as monotherapy could represent a transformative treatment option,” remarked CEO Marianne De Backer.
Durable virologic response
Vir had previously reported that five participants receiving combination therapy all had virologic response at week 12. Updated results presented at EASL showed that all five patients continued to have virologic response at week 48. The company noted that it is on track to report additional 24-week treatment data for all 60 participants in SOLSTICE during the fourth quarter.
Tobevibart, also known as VIR-3434, is a monoclonal antibody designed to inhibit entry of hepatitis delta viruses into hepatocytes. Meanwhile, elebsiran, formerly VIR-2218, is a small interfering RNA designed to degrade hepatitis B virus RNA transcripts as well as limit the production of hepatitis B surface antigen, and stems from the company’s collaboration with Alnylam Pharmaceuticals.
Vir is hoping that tobevibart and elebsiran – the firm’s lead assets – will fare better than its influenza A therapy VIR-2482, which last year flunked the Phase II PENINSULA trial. The setback prompted the company to cut costs, laying off 12% of its workforce, and prioritise investments in its chronic hepatitis delta and chronic hepatitis B programmes.
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