Gilead Sciences has reported positive data from clinical and preclinical studies exploring the use of its investigational class inhibitor GS-6207 as a potential therapy for HIV.
Results from the randomised, double-blind Phase Ib proof-of-concept study of a subcutaneous formulation found significantly greater reductions in HIV-1 RNA versus placebo across all treatment groups.
The dose-response study evaluated the safety, antiviral activity and pharmacokinetics (PK) of GS-6207 in people with HIV.
As part of the trial, 39 HIV patients were randomised to receive a single subcutaneous dose of the drug or placebo. The trial’s primary endpoint was the maximum reduction of plasma HIV-1 RNA to post-dose day 10.
Based on the data from the trial, GS-6207 was found to be safe and well-tolerated in healthy volunteers.
GS-6207 is an investigational agent and is being developed as a component of a long-acting regimen. The drug disrupts HIV capsid, a multimeric shell that is essential to viral replication, at multiple stages throughout the viral life cycle.
Gilead Sciences HIV and Emerging Viruses senior vice-president Diana Brainard said: “There have been significant advances in HIV therapy over the past three decades but for some people living with HIV, moving away from the need to take daily treatment is an important priority.
“By creating treatment options that can maintain virologic suppression regardless of a patient’s adherence to taking oral medications, our goal is to help people living with HIV remain virally suppressed for life.
“These promising early data are part of Gilead’s commitment to addressing the real-world needs of people living with HIV.”
Gilead acquired FDA Breakthrough Therapy Designation for the development of GS-6207 to treat HIV-1 infection in heavily treatment-experienced patients.