Abpro Corporation announced the initiation of global Phase 2/3 registrational studies evaluating the safety, tolerability, efficacy, and pharmacokinetics of ABP 300, a human neutralizing antibody for the treatment of COVID-19 derived from patients who have recovered from the SARS-CoV2 infection. The first trial site has been opened with the remainder to follow in 2021. The Phase 1 clinical trial, which included 42 subjects, study results are expected in First Quarter 2021. ABP 300 is a novel human antibody therapy that neutralizes COVID-19 by binding to the Receptor Binding Domain (RBD) of the SARS-CoV-2 spike protein, blocking the viral interaction with the angiotensin-converting enzyme 2 (ACE2) receptors of host which are critical for viral entry and infection. Through this mechanism of action, ABP 300 not only completely neutralizes COVID-19 in animal models but could potentially do so more safely and more effectively than other monoclonal antibodies already approved and in clinical development. A study validating the efficacy of ABP300’s mechanism of action in non-human primate models was recently published in Nature Communications. The Phase 2/3 will include a series of studies, including a global, multicenter, randomized, double-blind, placebo-controlled, pivotal registrational clinical trial of monoclonal antibody ABP 300 for the early treatment of patients with mild or moderate COVID-19. ABP 300 will be delivered in a one-time dose across 3 treatment arms using a 1:1:1 randomization comparing a high dose, low dose, and placebo. ABP 300 was developed to confer design features that potentially allow for more potent viral neutralization, higher efficacy against a larger number of strains, and enhanced safety benefits due to reduced antibody dependent enhancement (ADE), a potential adverse side effect of monoclonal antibody therapies.