The United States Food and Drug Administration has approved a unique potential cure for HIV to progress to human trials.
The one-time treatment using gene-editing technology could potentially represent a “functional cure” for HIV.
Excision BioTherapeutics Chief Executive Officer Daniel Dornbusch said that approval of the company’s EBT-101 treatment for a study using humans was an “important milestone” following “years of commitment to developing a functional cure for individuals living with HIV”.
Dornbusch said that the new treatment could cure HIV by making “multiple cuts to deactivate the viral genome”, overcoming the issue of the virus mutating.
Chief Medical Officer Dr Lisa Danzig said that EBT-101 had shown promising results in multiple animal models.
“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,” said Dr Danzig.
The new trial will include people living with HIV who are currently using antiretroviral therapy.
They will receive a single dose of EBT-101, then stop antiretroviral therapy under medical monitoring after several months.
Dornbusch said that the trial will demonstrate the safety of the new treatment and whether participants will remain HIV-negative.
He said that the goal of EBT-101 was developing a one-time “functional cure”, where people would remain HIV-negative with normal immune cell levels and no need for ongoing antiretroviral therapy.
Current antiretroviral therapy treatment typically allows people living with HIV to maintain an undetectable viral load, where the virus is present in extremely low amounts and cannot be passed on.
Forty years after the first cases of AIDS were reported, Australia is now on track to virtually eliminate HIV transmission by 2025, due also to medical technologies such as the preventive medication PrEP.