Vir Biotechnology Provides Corporate Update and Reports First Quarter 2021 Financial Results

SAN FRANCISCO, May 06, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the first quarter ended March 31, 2021.

“We’ve had an active start to the year, achieving significant clinical and collaboration milestones across our portfolio of investigational compounds for serious infectious diseases,” said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. “Based on the profound efficacy results from our Phase 3 trial of VIR-7831 and our belief in its ongoing ability to address known variants of concern, we remain confident in the potential of this dual-action monoclonal antibody to play an important role in bringing the COVID-19 pandemic to an end. We look forward to the pending Emergency Use Authorization decisions in the U.S. and Europe. In the interim, we are rapidly progressing the initiation of new studies aimed at both the prevention and treatment of COVID-19, as well as new delivery methods that we hope will help ease administration and access in the future. Importantly, we are also excited to share several new data sets from our robust hepatitis B pipeline in the second quarter, and expect to maintain our executional momentum throughout the year.”

Corporate Update

COVID-19 Updates

• In February, the Company initiated COMET-PEAK (COVID-19 Monoclonal antibody Efficacy Trial - Patient SafEty, TolerAbility, PharmacoKinetics), a Phase 2 trial with two parts. The first part, initiated in February, is evaluating the similarity in pharmacokinetics between VIR-7831 manufactured by different processes. The second part, which began in April, is comparing the safety and viral kinetics of intramuscularly (IM) administered VIR-7831 to intravenously (IV) administered VIR-7831 among low-risk adults with mild to moderate COVID-19. The low 500 mg dose of VIR-7831 lends itself to administration via an IM route, and could facilitate broader access to monoclonal antibody therapy in settings where IV administration is not feasible. Data are expected in the second half of 2021.
• In March, the Company announced that the VIR-7831 arm of the National Institutes of Health’s (NIH) ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) Program Phase 3 clinical trial met initial pre-specified criteria, and no safety signals were reported. Based on sensitivity analyses of the available data, the independent Data and Safety Monitoring Board recommended the VIR-7831 arm be closed to enrollment. The Company anticipates an NIH-led manuscript to be published later this year.
• In March, the Company announced an Independent Data Monitoring Committee (IDMC) recommended the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of profound efficacy. The IDMC recommendation was based on an interim analysis of data from 583 patients enrolled in the COMET-ICE trial, which demonstrated an 85% (p=0.002) reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo, the primary endpoint of the trial. VIR-7831 was well tolerated. As the trial remains ongoing and blinded with patients continuing to be followed for 24 weeks, additional results, including epidemiology and virology data, will be forthcoming once the trial is completed.
• In March, the Company announced the submission of an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) for VIR-7831 for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death. The submission is based on the interim analysis of efficacy and safety data from the Phase 3 COMET-ICE trial. These data will also form the basis for a Biologics License Application (BLA) submission to the FDA, planned in the second half of 2021.
• In March, the Company announced topline data from Eli Lilly and Company’s (Eli Lilly) expanded Phase 2 BLAZE-4 trial evaluating the potential benefits of VIR-7831 together with Eli Lilly’s investigational bamlanivimab (LY-CoV555) in low-risk adult patients with mild to moderate COVID-19. Results from the trial, which began dosing in January, showed that bamlanivimab 700 mg co-administered with VIR-7831 500 mg demonstrated a 70% (p5.27; cycle threshold value