16 april 2021: Bron: Vir Biotechnology, Inc. and GlaxoSmithKline plc

VIR-7831 een monoklonaal antilichaam als medicijn voor de behandeling van patiënten die zijn besmet met het coronavirus - COVID-19  geeft hele goede resultaten blijkt uit Amerikaans onderzoek. Uit de gerandomiseerde placebo gecontroleerde fase III studie COMET-ICE blijkt dat VIR-7831 wanneer direct gegeven na eerste besmettingsverschijnselen van patiënten met een hoog risico op ernstige ziekte 85 procent minder ziekenhuisopnames nodig zijn en overlijden aan de ziekte wordt voorkomen met minimaal 85 procent in vergelijking met de patiënten uit de placebogroep. 

Het Independent Data Monitoring Committee (IDMC) heeft op basis van deze resultaten aanbevolen dat de fase 3-studie COMET-ICE geen nieuwe deelnemers meer aanneemt en na eindevaluatie wordt stopgezet wegens bewijs van grote werkzaamheid.

De IDMC-aanbeveling is gebaseerd op een tussentijdse analyse van gegevens van 583 patiënten die deelnamen aan de COMET-ICE-studie, die een vermindering van 85% (p = 0,002) aantoonde in ziekenhuisopname of overlijden bij patiënten die VIR-7831 als monotherapie kregen in vergelijking met placebo, het primaire einddoel van de studie.
VIR-7831 als behandeling werd goed verdragen met weinig ernstige bijwerkingen. Aangezien de studie nog lopende is en verblind is met patiënten die gedurende 24 weken worden gevolgd, zullen aanvullende resultaten, waaronder epidemiologische en virologische gegevens, bekend worden gemaakt zodra het onderzoek is voltooid.

Bij de FDA is inmiddels een verzoek tot goedkeuring voor VIR-7831 aangevraagd. Ook de EMA gaat kijken naar dit medicijn.

Dit zijn / waren de voorwaarden om aan deze studie deel te kunnen nemen:

Inclusiecriteria:
  • De deelnemer moet 18 jaar of ouder zijn EN een hoog risico lopen op progressie van COVID-19 of ≥ 55 jaar oud
  • Deelnemers moeten een positief SARS-CoV-2-testresultaat hebben en een zuurstofverzadiging ≥ 94% in de kamerlucht en COVID-19-symptomen hebben en minder dan of gelijk zijn aan 5 dagen vanaf het begin van de symptomen

Uitsluitingscriteria:
  • Momenteel in het ziekenhuis opgenomen of volgens de onderzoeker waarschijnlijk in de komende 24 uur opgenomen
  • Symptomen die overeenkomen met ernstige COVID-19
  • Deelnemers die naar het oordeel van de onderzoeker de komende 7 dagen waarschijnlijk zullen overlijden
  • Ernstig immuungecompromitteerde deelnemers
Voor het persbericht van de producenten van VIR-7831 klik op de titel: 

Vir Biotechnology and GSK announce VIR-7831 reduces hospitalisation and risk of death in early treatment of adults with COVID-19

For media and investors only

Issued: London UK; San Francisco US

  • Independent Data Monitoring Committee recommends stopping Phase 3 COMET-ICE trial early given an 85% reduction in hospitalisation or death.
  • Vir and GSK plan to immediately seek Emergency Use Authorization in the US and authorisations in other countries.
  • Additional new in vitro studies indicate VIR-7831 maintains activity against major circulating COVID-19 variants.

Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that an Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial evaluating VIR-7831 (GSK4182136) as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation be stopped for enrolment 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 hospitalisation 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.

Based on these results, Vir and GSK plan to submit an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) and for authorisations in other countries. Data from this registrational trial will also form the basis for a Biologics License Application (BLA) submission to the FDA.

The companies also announced today the results of a new study submitted and pending online publication in bioRxiv, demonstrating that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants, based on in vitro data from pseudotyped virus assays. In contrast to other monoclonal antibodies, VIR-7831 binds to a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop.

In addition to COMET-ICE, the full COMET clinical development programme for VIR-7831 includes:

  • COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered VIR-7831 to 500 mg intravenously administered VIR-7831 among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity and pharmacokinetics between VIR-7831 manufactured by different processes.
  • COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalisation or death due to COVID-19.
  • COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic infection.

George Scangos, Ph.D., Chief Executive Officer of Vir said: “These exciting data with a single antibody against a conserved epitope bring us one step closer to delivering an effective new solution to patients around the globe. The dual-action design of VIR-7831 to both block viral entry into healthy cells and clear infected cells, as well as its high barrier to resistance, are key distinguishing characteristics. These findings, paired with our pending publication of resistance data, demonstrate the potential of VIR-7831 to prevent the most severe consequences of COVID-19 and highlight its potential ability to protect against the current circulating strains of the virus.”

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK said: “We are pleased that this unique monoclonal antibody was able to bring such a profound benefit to patients. We look forward to the possibility of making VIR-7831 available to patients as soon as possible and to further exploring its potential in other settings.”

The Phase 3 portion of the COMET-ICE trial assessed the safety and efficacy of a single intravenous infusion of VIR-7831 (500 mg) or placebo in non-hospitalised participants globally, and this interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalisation for at least 24 hours or death within 29 days of randomisation. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American. According to the Centers for Disease Control and Prevention these populations are approximately three times more likely to be hospitalised[1] and approximately two times more likely to die[2] of COVID-19.

VIR-7831 is also being evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of Eli Lilly’s bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralising antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19.

Additionally, VIR-7831, along with VIR-7832, will be evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

VIR-7831 and VIR-7832 are investigational compounds, not approved by the U.S. Food and Drug Administration or any other regulatory authority.

COMET-ICE clinical trial design

The multi-centre, double-blind, placebo-controlled COMET-ICE trial is investigating VIR-7831 in adults with mild or moderate COVID-19 who are at high risk of progression to severe disease. The Phase 1 lead-in portion of the trial, which served as the first-in-human assessment, evaluated the safety and tolerability of a single 500 mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in 21 non-hospitalised adults enrolled across the United States.

In October 2020, based on a positive evaluation of safety and tolerability data of VIR-7831 from the lead-in part of the trial by an Independent Data Monitoring Committee, the trial began enrolling patients in North America and additional sites in South America and Europe in the global Phase 3 portion of the trial. This part of the trial is assessing the safety and efficacy of a single IV infusion of VIR-7831 or placebo in up to 1,300 non-hospitalised participants globally.>>>>>>>reed more

References

[1] Data source: COVID-NET (https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covid-net/purpose-methods.html, accessed March 1, 2020, through January 30, 2021). Numbers are ratios of age-adjusted rates standardized to the 2019 US standard COVID-NET catchment population.

[2] Data source: NCHS provisional death counts (https://data.cdc.gov/NCHS/Deaths-involving-coronavirus-disease-2019-COVID-19/ks3g-spdg, data through January 30, 2021). Numbers are ratios of age-adjusted rates standardized to the 2019 US intercensal population estimate.


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