Positive COVID-19 efficacy numbers from Vir Biotechnology Inc. and Glaxosmithkline plc (GSK) has prompted them to immediately seek an emergency use authorization (EUA) with the FDA and similar authorizations in other countries for their monoclonal antibody, VIR-7831.
Meanwhile, the phase III Remdacta study of Actemra/RoActemra (tocilizumab) plus Veklury (remdesivir) vs. placebo plus Veklury, from Roche Holding AG and Gilead Sciences Inc., missed its primary endpoint in treating hospitalized patients with severe COVID-19 pneumonia receiving standard of care. Veklury is an antiviral designed to help stop SARS-CoV-2 replication.
Citing the Vir-GSK drug’s evidence of “profound efficacy,” an independent data monitoring committee recommended stopping enrollment in the phase III COMET-ICE trial of VIR-7831 for early treatment of COVID-19 in adults at high risk of hospitalization. An interim analysis of data from 583 patients enrolled in the study showed an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 as a monotherapy compared to placebo, the primary endpoint of the trial.
The independent data monitoring committee based its recommendation on those data.
Vir’s stock (NASDAQ:VIR) soared 32% on March 11, with shares closing at $61.83 each. The stock is 41.6% higher than its close on March 16, 2020.
The benefit is consistent with recently announced positive results for antibody cocktails from Eli Lilly and Co. and Regeneron Inc., SVB Leerink analyst Geoffrey Porges wrote on March 11, and suggests that preliminarily at least, the Vir antibody has as much neutralizing activity as its competitors’ cocktail products.
“With hospital systems just beginning to recover from the new year’s wave of patients, we note that capacity may be limited for an infused therapy. We believe that to succeed with '7831, GSK will have to educate providers on which patients could make good candidates for the MAb and work with health systems to streamline approval and capacity for the infusion,” Porges added.
As of March 8, the EMA’s Committee for Medicinal Products for Human Use issued positive scientific opinion for bamlanivimab alone and bamlanivimab plus etesevimab for treating confirmed COVID-19 in patients 12 and older who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.
Initial phase III data of Regeneron’s antibody cocktail, REGEN-COV (casirivimab and imdevimab), for use as a passive vaccine to prevent COVID-19 in high-risk individuals, showed 100% efficacy in preventing symptomatic infection and about 50% lower overall rates of symptomatic and asymptomatic infection.
Cowen analyst Phil Nadeau wrote March 11 that the firm thinks the Vir-GSK results position VIR-7831 to be a best-in-class COVID-19 antibody.
The COMET development program for VIR-7831 also includes COMET-PEAK, an ongoing phase II trial comparing 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 in pharmacokinetics between VIR-7831 manufactured by different processes.
Other VIR-7831 programs are COMET-TAIL, a phase III study expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19, and also COMET-STAR, a phase III study 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.
Nadeau wrote a few days earlier, on March 8, that the firm believes successful outcomes in the IM programs could position Vir and GSK for commercial success ahead of a potential renewed surge of COVID-19 infection rates in the 2021-2022 season.
Roche and Gilead stumble
In addition to missing the Remdacta clinical trial’s primary endpoint, the randomized, double-blind Roche-Gilead phase III study of Actemra plus Veklury vs. placebo plus Veklury also failed to meet some key secondary endpoints, including the likelihood of patient death, likelihood of progression to mechanical ventilation or death, and clinical status.
The primary endpoint was measured as the improved time to hospital discharge up to day 28 in those with severe COVID-19 pneumonia and receiving the standard of care.
In September, Roche’s phase III Empacta study of 389 hospitalized patients showed that 12.2% of those in the active treatment arm progressed to mechanical ventilation over 28 days, as compared with 19.3% of those in the control arm. Empacta, which hit its primary endpoint, evaluated the efficacy and safety of Actemra/RoActemra in treating hospitalized COVID-19 patients with pneumonia.