Abpro Announces Positive Phase 1 Results Demonstrating A Favorable Safety and Pharmacokinetic Profile of ABP 300, A Neutralizing Antibody Therapeutic for the Treatment of COVID-19
WOBURN, Mass., Feb. 02, 2021 (GLOBE NEWSWIRE) -- Abpro Corporation today announced the results of a Phase 1 study demonstrating a favorable safety and pharmacokinetic profile of ABP 300, a human neutralizing antibody for the treatment of COVID-19 derived from patients who have recovered from the SARS-CoV-2 infection. The Phase 1 clinical trial was conducted in 42 healthy subjects and showed safety and pharmacokinetic data at doses from 4 mg/kg to 60 mg/kg. Following the completion of this Phase 1 in December 2020, a series of Phase 2/3 registrational studies of ABP 300 has recently been initiated.
“A key quality in any approvable antibody treatment, especially for those being administered to already-vulnerable COVID-19 patients, will be safety and tolerability and we are pleased to have observed such promising safety signals with ABP 300,” said Ian Chan, chief executive officer of Abpro. “Completion of this safety study in December stands as an encouraging validation of this potentially best-in-class therapy. The Phase 2/3 is anticipated to include up to 2,000 patients in the aggregate in 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 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 ABP 300’s mechanism of action in non-human primate models was recently published in Nature Communications.
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.
About ABP 300
ABP 300 is a human neutralizing monoclonal antibody therapy against COVID-19 that was created using the latest technologies available for antibody discovery. It was isolated from a patient who recovered from COVID-19 and engineered for highest safety and efficacy. ABP 300 disrupts the interaction of the viral receptor binding domain (RBD) with host angiotensin-converting enzyme 2 (ACE2) receptor and has shown neutralizing efficacy in vivo against COVID-19 by blocking viral entry into cells. Data has been published in Nature Communications. ABP 300 is currently being studied in Phase 2/3 global registrational studies in patients with COVID-19.
About Abpro
Abpro Corporation is a clinical stage biotechnology company located in Woburn, Massachusetts. The Company’s mission is to improve the lives of mankind facing severe and life-threatening diseases with next-generation antibody therapies. Abpro’s DiversImmune™ platform has been used successfully to generate monoclonal antibodies against 300 traditionally difficult targets. The Diversimmune™ platform combines the latest in nano-immunology, next-generation sequencing, advanced engineering and bioinformatics to create monoclonal antibodies against traditionally difficult targets. The Company has a pipeline of therapies to treat cancer, eye, autoimmune, infectious diseases and other areas. For more information, please visit www.abpro.com.
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