Abpro Announces Initiation of Phase 2/3 Registrational Studies of its Neutralizing Antibody Therapeutic ABP 300 for the Treatment of COVID-19

  • ABP 300 is a novel human antibody therapy that has been shown to neutralize COVID-19 in preclinical in vivo studies
  • Pivotal/Registrational studies will assess safety, tolerability, efficacy, and pharmacokinetics of ABP300 in approximately 2,000 subjects  

WOBURN, MA, USA I December 16, 2020 I Abpro Corporation today 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 Q1 2021.

“The initiation of global pivotal studies of ABP300 is a significant milestone for our company. It comes at a critical time as mankind battles another wave of COVID-19 and hospitalizations continue to rise,” said Ian Chan, chief executive officer of Abpro. “Neutralizing antibodies have not only demonstrated efficacy as a first line therapy for newly diagnosed COVID-19 patients but are well positioned to serve as the main therapy for patients who do not receive, or do not respond to COVID-19 vaccines. We feel this is especially true of our antibody drug candidate, which based on non-human primate and clinical in-human safety data, holds promise for effective COVID-19 treatment, and we look forward to reporting data from this study in Q1 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. This is one of the only studies of its kind demonstrated in the industry to date.        

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.

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.  


La Merie Biologics

FREE Weekly News Bulletin

Sign Up

2020 Sales ofAntibodies & Proteins

New Product Alert

For La Merie Publishing

Sign Up