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Open Forum Infect Dis . The Designed Ankyrin Repeat Protein Antiviral Ensovibep for Nonhospitalized Patients With Coronavirus Disease 2019: Results From EMPATHY, a Randomized, Placebo-Controlled Phase 2 Study

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  • Open Forum Infect Dis . The Designed Ankyrin Repeat Protein Antiviral Ensovibep for Nonhospitalized Patients With Coronavirus Disease 2019: Results From EMPATHY, a Randomized, Placebo-Controlled Phase 2 Study

    Open Forum Infect Dis


    . 2024 May 3;11(6):ofae233.
    doi: 10.1093/ofid/ofae233. eCollection 2024 Jun. The Designed Ankyrin Repeat Protein Antiviral Ensovibep for Nonhospitalized Patients With Coronavirus Disease 2019: Results From EMPATHY, a Randomized, Placebo-Controlled Phase 2 Study

    Jeff Kingsley 1 , Nagalingeswaran Kumarasamy 2 , Luis Abrishamian 3 , Marc Bonten 4 , Awawu Igbinadolor 5 , Martha Mekebeb-Reuter 6 , Jennifer Rosa 7 , Damodaran Solai Elango 8 , Patricia Lopez 9 , Pierre Fustier 10 , Susana Goncalves 9 , Charles G Knutson 11 , Petra Kukkaro 9 , Philippe Legenne 10 , Krishnan Ramanathan 9 , Shantha Rao 12 , Evgeniya Reshetnyak 12 , Vaia Stavropoulou 10 , Nina Stojcheva 10 , Michael T Stumpp 10 , Andreas Tietz 9 , Marianne Soergel 10 , Richa Chandra 12



    AffiliationsAbstract

    Background: The coronavirus disease 2019 (COVID-19) pandemic was characterized by rapid evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, affecting viral transmissibility, virulence, and response to vaccines/therapeutics. EMPATHY (NCT04828161), a phase 2 study, investigated the safety/efficacy of ensovibep, a multispecific designed ankyrin repeat protein (DARPin) with multivariant in vitro activity, in ambulatory patients with mild to moderate COVID-19.
    Methods: Nonhospitalized, symptomatic patients (N = 407) with COVID-19 were randomized to receive single-dose intravenous ensovibep (75, 225, or 600 mg) or placebo and followed until day 91. The primary endpoint was time-weighted change from baseline in log10 SARS-CoV-2 viral load through day 8. Secondary endpoints included proportion of patients with COVID-19-related hospitalizations, emergency room (ER) visits, and/or all-cause mortality to day 29; time to sustained clinical recovery to day 29; and safety to day 91.
    Results: Ensovibep showed superiority versus placebo in reducing log10 SARS-CoV-2 viral load; treatment differences versus placebo in time-weighted change from baseline were -0.42 (P = .002), -0.33 (P = .014), and -0.59 (P < .001) for 75, 225, and 600 mg, respectively. Ensovibep-treated patients had fewer COVID-19-related hospitalizations, ER visits, and all-cause mortality (relative risk reduction: 78% [95% confidence interval, 16%-95%]) and a shorter median time to sustained clinical recovery than placebo. Treatment-emergent adverse events occurred in 44.3% versus 54.0% of patients in the ensovibep and placebo arms; grade 3 events were consistent with COVID-19 morbidity. Two deaths were reported with placebo and none with ensovibep.
    Conclusions: All 3 doses of ensovibep showed antiviral efficacy and clinical benefits versus placebo and an acceptable safety profile in nonhospitalized patients with COVID-19.

    Keywords: COVID-19; DARPin; SARS-CoV-2; ensovibep; randomized clinical trial.

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