The first-in-human clinical trial for a candidate treatment for individuals living with human immunodeficiency virus type 1 is starting soon after its maker, Excision BioTherapeutics, today received an Investigational New Drug clearance from the U.S. Food and Drug Administration (FDA).
The FDA’s IND approval sets the stage for the very first Phase I/II trial to evaluate EBT-101 as a functional cure for chronic HIV based on the endpoints of safety, tolerability, and efficacy.
EBT-101, an in vivo, CRISPR-based drug that targets HIV proviral DNA, is a unique gene therapy that leverages CRISPR’s viral defense capability against bacteria. It uses an adeno-associated virus (AAV) to deliver a one-time treatment to functionally cure HIV infections. Preclinical studies show that it can excise HIV proviral DNA in multiple cell lines, including both human primary cells and multiple animal models and non-human primates.
Comments are closed.