Words: Jamie Tabberer; picture: Pexels
A biotech company has received clearance to begin human trials for a possible "functional cure" for HIV.
A functional cure is when a virus is not completely eliminated by the body's immune system but can be controlled without medication.
Following approval from The U.S. Food and Drug Administration (FDA), phase one of the trial from Excision BioTherapeutics, Inc. - a developer of CRISPR-based therapies intended to cure viral infectious diseases - is expected to start later this year.
The company announced news of "EBT-101, [the] first-in-human CRISPR-based one-time gene therapy to be evaluated in individuals with HIV" in a statement on its website.
"An important milestone"
Daniel Dornbusch, Chief Executive Officer of the San Francisco-based group commented: “The clearance of our IND application for EBT-101 represents an important milestone for Excision and is the result of years of commitment to developing a functional cure for individuals living with HIV.
“Although antiviral treatments can manage HIV infection, they require life-long treatment, cause side effects, and do not provide the possibility of a functional cure. We are grateful for the FDA’s engaged review and acceptance of the IND for EBT-101 and look forward to initiating the Phase 1/2 clinical trial later this year.”
Lisa Danzig, MD, Excision’s Chief Medical Officer, added: “EBT-101 has demonstrated removal of proviral DNA in multiple animal models and offers an opportunity for individuals living with HIV to potentially cease life-long therapies. The Excision team looks forward to this important collaboration with our principal investigators, scientific advisors, and regulators, to conduct a safe and informative trial with this first-in-class approach to a viral disease target previously considered to be incurable.”
Added a rep: "The FSA has accepted the Investigational New Drug (IND) application for EBT-101, a CRISPR-based therapeutic candidate in development as a potential functional cure for chronic HIV. The IND clearance enables Excision to initiate a first-in-human Phase 1/2 clinical trial to evaluate the safety, tolerability, and efficacy of EBT-101 in individuals living with human immunodeficiency virus type 1 (HIV)."
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