I find this drug candidate very interesting; it is

I find this drug candidate very interesting; it is vital that leronlimab as monotherapy has a couple of years headstart (if Gilead can bring this to market at all). I hope that pivotal mono protocol can be finalized soon and the trial started in the next few months after funding has been secured... Of course cancer is the bigger prize, but...

Gilead’s Investigational HIV-1 Capsid Inhibitor GS-6207 Presented at CROI 2020

Wed March 11, 2020 3:09 PM|Business Wire|About: GILD

– Phase 1B Study Demonstrates the Potential of GS-6207 to Rapidly Reduce Viral Load After a Single Subcutaneous Injection –

– Gilead Progresses Long-Acting Therapy Research Program to Help Address Real-World Challenges for People Living with HIV –

BOSTON--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) today announced data from clinical and preclinical studies exploring the use of GS-6207, an investigational, novel, first-in-class inhibitor of HIV-1 capsid function, as a potential long-acting therapy for people living with HIV. Results from a Phase 1b proof-of-concept study of a subcutaneous formulation showed antiviral activity with GS-6207 through the last day of monotherapy, Day 10, with significantly greater reductions in HIV-1 RNA versus placebo across all treatment groups (20 to 750 mg; all p<0.0001). These data were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2020 in Boston.

Additional data presented at CROI provided further information on the potential utility of GS-6207 that support further development of the compound. Phase 1 data in healthy volunteers evaluating an oral tablet formulation found GS-6207 to be generally safe and well-tolerated with a pharmacokinetic profile supporting once a week administration without regard to food. Results from a preclinical study evaluating the impact of resistance mutations on the in vitro antiviral activity of GS-6207 were also presented. In this in vitro study, GS-6207 was not affected by mutations at the gag cleavage sites or by mutations associated with resistance to the four main classes of antiretroviral agents.

“The antiviral activity and safety profiles demonstrated in these early preclinical and clinical studies suggest the potential of GS-6207 as a long-acting treatment for people living with HIV, including those with multi-class drug resistance,” said Eric S. Daar, MD, Chief of the Division of HIV Medicine at Harbor-UCLA Medical Center, Chief of HIV Services at the Lundquist Institute for Biomedical Innovation, Professor of Medicine at UCLA. “A long-acting therapy could offer an important option for people living with HIV who are unable to take a daily pill. These findings are an encouraging step toward ensuring more treatment options to fit the diverse needs of people living with HIV.”

“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,” said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. “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.”

GS-6207 is an investigational agent that is being developed as a component of a long-acting regimen. GS-6207 disrupts HIV capsid, a multimeric shell that is essential to viral replication, at multiple stages throughout the viral life cycle. The FDA granted Breakthrough Therapy Designation for the development of GS-6207 for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs.Data from Phase 1 studies that demonstrate GS-6207’s antiviral activity and its potential for a dosing interval of up to every six months were presented at the 17th European AIDS Conference (EACS) in Basel, Switzerland in 2019.