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VIR > pipeline update...

New data from the ongoing Phase 2 trial of VIR-2218, an HBV-targeting small interfering ribonucleic acid being developed for the functional cure of HBV, continue to show substantial reductions in HBV surface antigen and that VIR-2218 continues to be generally well-tolerated.

All HBeAg negative and positive patients who received two doses of 200 mg of VIR-2218 achieved at least a 1.0 log10 decline in HBsAg. At Day 85, a mean decline of 1.5 log10 was observed in both HBeAg negative and positive patients.

No alanine aminotransaminase abnormalities greater than or equal to three times the upper limit of normal have been observed in any person treated with VIR-2218, including the 37 healthy volunteers given up to 900 mg of VIR-2218 and the 24 patients who received up to two doses of 200 mg of VIR-2218.Data through at least week 16 on all VIR-2218 dose cohorts are expected to be available in the first half of 2020.

The company anticipates that two new trials with VIR-2218 will start later this year, including a Phase 2 trial of VIR-2218 in China, in collaboration with Brii Biosciences, and a Phase 2 combination trial of VIR-2218 and pegylated interferon-alpha. In addition, VIR-3434, an HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes, reduce the level of virions and subviral particles in the blood, and potentially function as a T cell vaccine, is on track for clinical trial application approval in the first half of 2020. VIR-2482, a mAb antibody being developed as universal prophylaxis for influenza A, continues to progress in the clinic, with all four dose cohorts in healthy volunteers completed and regulatory approvals on track to commence Phase 2 dosing in the southern hemisphere in the second quarter of 2020.

The company continues to anticipate data from the first flu season of the trial to be available in the second half of 2020 and from the second flu season of the trial to be available in the first half of 2021. VIR-1111, an HIV T cell vaccine based on human cytomegalovirus, continues to be on track for an investigational new drug submission in the first half of 2020.

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https://thefly.com/landingPageNews.php?id=3017089