Human trials are about to begin on a potentially groundbreaking HIV treatment that is being hailed as a possible “cure” for the virus.
According to a press release from Excision Biotherapeutics, a biotech company, America’s Food and Drug Administration (FDA) approved the treatment’s progression to Phase I/II human trials.
Excision’s potential cure is known as EBT-101 and is being developed in partnership with researchers from Temple University in Philadelphia.
EBT-101 cuts numerous pieces of the HIV genome in a bid to make it unable to mutate inside the body.
Speaking to Fierce Biotech, Excision’s CEO Daniel Dornbusch said: “If you just make a single cut, the virus can mutate around it. We make multiple cuts to deactivate the viral genome.”
The Nobel Prize-winning CRISPR gene-editing technology is at the core of a lot of the company’s work and allows for the modification of human DNA.
According to Excision, EBT-101 could “functionally cure” humans living with HIV, as preliminary research has shown its effectiveness at removing HIV proviral DNA – a latent form of the virus that replicates along with human cells in the body.
Dornbusch explained to Philadelphia magazine that the term “functional cure” means small amounts of HIV could remain in the body, but not at a level that would make the affected person test positive for the virus.
He added: “Sterilizing cures are not necessary, as the goal of the therapy will be for individuals to remain HIV negative by RNA testing, maintain normal levels of immune cells, and cease taking antiretroviral treatment — achieving a functional cure.”
The CEO went on to explain that EBT-101’s goal is to be a one-time treatment that would eradicate a patients’ need for antiretroviral therapies (ART).
ART works by combining a few HIV medications that decrease the amount of the virus present in the body so it is unable to attack the immune system.
This can result in a person being undetectable, making it impossible for them to pass the virus on to someone else.
Dornbusch said: “They require life-long treatment, cause side effects, and do not provide the possibility of a functional cure.”
Trials for the new treatment will include people using ART to control their HIV, with those participating receiving one dose of EBT-101 and remaining on ART for three months.
After this period, they will no longer take ART and be checked for the return of HIV.
Excision will also test the treatment at numerous dose levels to find which works best.
According to the World Health Organisation (WHO), 3.7 million people were living with HIV worldwide in 2020.
Since the start of the epidemic, 79.3 million people have been infected with the virus and 36.3 million have sadly died.