FDA Approves First Human Trial For HIV Cure

The first-in-human clinical study for a prospective treatment for people living with human immunodeficiency virus type 1 will begin soon after its developer, Excision BioTherapeutics, got FDA approval as an Investigational New Drug today (FDA).

The FDA’s IND authorization clears the way for first Phase I/II trial to assess EBT-101 as a potential cure for chronic HIV using safe, tolerability, and efficacy as outcomes.

EBT-101, a CRISPR-based gene therapy that attacks HIV proviral DNA in vivo, is a one-of-a-kind gene therapy that takes advantage of CRISPR’s viral defensive mechanism against microbes. It delivers a one-time therapy to functionally treat HIV infections using an adeno-associated virus (AAV).

CRISPR is a technology that can clip HIV from a patient’s DNA cell if it has managed to wrap itself into it. Over the years, HIV’s snake-like characteristics have made it nearly hard to eradicate.

The “genetic scissors” developed by CRISPR, for which Drs Jennifer Doudna and Emmanuelle Charpentier was awarded the Nobel Prize in chemistry in 2020, would eliminate the need for patients to take virus suppression medicines to prevent HIV from progressing to AIDS.

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