Gilead Sciences Presents Data Supporting a Potential Six-Month Dosing Interval for Investigational HIV-1 Capsid Inhibitor Lenacapavir (GS-6207)
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from an ongoing Phase 1 study, which showed that a sustained-delivery subcutaneous formulation of the company’s investigational, novel inhibitor of HIV-1 capsid function, lenacapavir (GS-6207), sustained predicted therapeutic concentrations for at least six months following a single 900 mg dose. In the study, lenacapavir was generally well-tolerated, and no serious adverse events were reported. These data were presented at the 23rd International AIDS Conference (AIDS 2020: Virtual).
“Long-acting antiretroviral therapy may help address challenges with treatment adherence and treatment fatigue, providing additional options to people living with HIV,” said Eric S. Daar, MD, Chief of the Division of HIV Medicine at the Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center and Professor of Medicine at the David Geffen School of Medicine at UCLA. “The promising safety and pharmacokinetic profiles of lenacapavir support continued evaluation of an every six-month dosing interval and further demonstrate the potential for a single subcutaneous injection of lenacapavir to be part of a long-acting HIV treatment regimen.”
Lenacapavir is an investigational agent that is being developed as a component of a long-acting regimen in combination with other antiretroviral agents. Lenacapavir disrupts HIV capsid, a multimeric shell that is essential to viral replication, at multiple stages throughout the viral life cycle. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs.
“There is a compelling unmet need for interventions that can potentially improve treatment adherence to chronic HIV therapy, including the development of long-acting formulations, which can be administered less frequently,” said Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. “We hope to make HIV a more manageable part of people’s lives through continued treatment innovations, including the exploration of dosing intervals that coincide with regularly scheduled visits with healthcare providers.”
The safety, efficacy and dosing of lenacapavir are being evaluated in multiple ongoing clinical studies, and have not yet been established. Initial data from Phase 1 studies that assessed the antiviral activity of lenacapavir were presented at the 17th European AIDS Conference (EACS) in Basel, Switzerland in 2019 and presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2020 in Boston, Mass.