Abpro Announces Initiation of Phase 2/3 Registrational Studies of its Neutralizing Antibody Therapeutic ABP 300 for the Treatment of COVID-19
- Category: Antibodies
- Published on Wednesday, 16 December 2020 18:15
- Hits: 887
- 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.
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.