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Monday, July 22, 2019

Gilead Presents Proof of Concept Data for GS-6207, 1st-in-Class HIV Capsid Inhibitor

Phase 1b Study Demonstrates Potent Antiviral Efficacy Following a Single Subcutaneous Injection of GS-6207, No Discontinuations Due to Adverse Events –
Gilead Sciences, Inc. (NASDAQ: GILD) today presented the first clinical data in people living with HIV on GS-6207, an investigational, novel, selective, first-in-class inhibitor of HIV capsid function. The Phase 1b data demonstrate the first proof of concept that HIV capsid inhibition can lead to significant declines in viral load in vivo. In addition, Gilead presented preclinical data demonstrating that resistance to GS-6207 in vitro did not lead to resistance to other classes of drugs used in the treatment of HIV. These data were presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City.
GS-6207 is an investigational long-acting antiretroviral agent that can be delivered subcutaneously. GS-6207 recently received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) as a potential therapy for heavily treatment-experienced people living with multi-drug resistant HIV. GS-6207 acts in a novel way compared with currently available antiretroviral agents by interrupting the activity of HIV capsid, a protein that surrounds and protects the virus’ genetic material and essential enzymes. GS-6207 may interrupt multiple distinct stages of the viral lifecycle, potentially preventing the virus from becoming infectious and gaining access to uninfected cells.
“The data presented at IAS underscore our commitment to scientific discovery, building on Gilead’s legacy of transformative advances in HIV therapies,” said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. “GS-6207’s multi-stage mechanism of action profile is distinguishable from currently approved classes of antiretroviral agents and may provide a new avenue for the development of long-acting treatment regimens for people living with HIV.”

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