GlaxoSmithKline and Vir Biotechnology said Monday that the first patient was dosed last week in the Phase II/III COMET-ICE trial evaluating the anti-SARS-CoV-2 monoclonal antibody VIR-7831 for the early treatment of COVID-19 in patients at high risk of progressing to severe disease, such as the elderly or those with pre-existing conditions like lung or heart disease. The companies suggested that initial study data could be available before the end of this year, with complete results expected in the first quarter of 2021, and potentially early access to the antibody treatment as soon as the first half of 2021.
The move follows a deal in April under which the companies agreed to collaborate on antiviral antibodies for coronaviruses, including SARS-CoV-2, with an initial focus on VIR-7831, also known as GSK4182136, and on VIR-7832, another SARS-CoV-2 neutralising antibody. That agreement also saw GlaxoSmithKline make an equity investment of $250 million in Vir, priced at $37.73 per share.
The first lead-in part of COMET-ICE will evaluate safety and tolerability of a single intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in 20 non-hospitalised patients across the US. In the second expansion phase, researchers will assess safety and efficacy of a single IV infusion of VIR-7831 or placebo in roughly 1300 non-hospitalised participants globally. The primary endpoint is the proportion of patients with mild-or-moderate COVID-19 who worsen, as defined by death or the need for hospitalisation, within 29 days of randomisation.
"Hospital systems are overwhelmed worldwide, with new infections continuing to strain already limited resources," remarked George Scangos, chief executive at Vir, adding "treating those with early COVID-19 disease so that it doesn't become worse is critical both for the patients and for society."
GlaxoSmithKline and Vir plan to run two more trials on VIR-7831, including one for the treatment of severely ill hospitalised patients, and another for the prophylaxis of symptomatic infection. Meanwhile, later this year, they expect to start a mid-stage study of VIR-7832, which they say "shares the same characteristics as VIR-7831, but may in addition also function as a therapeutic and/or prophylactic T-cell vaccine."
Regeneron, which is boosting production capacity for its COVID-19 antibody cocktail REGN-COV2 via a recent deal with Roche, expects initial data from ongoing trials in September. REGN-COV2 is currently being studied in two Phase II/III trials for the treatment of COVID-19 and in a Phase III study for the prevention of COVID-19 in household contacts of infected individuals.
Meanwhile, Eli Lilly said earlier in August that it started a Phase III study examining whether its AbCellera-partnered antibody-based drug LY-CoV555 can prevent infections in nursing homes. A separate trial testing the compound on recently diagnosed COVID-19 patients may yield initial data in September or shortly after.
"We're coming into the clinic a little bit later," noted Scangos, but "part of that is because we spent some time selecting what we believe will be a best-in-class antibody."
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