Gilead Presents Proof-of-Concept Data for GS-6207, a First-in-Class Capsid Inhibitor, in People Living With HIV

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 10^th 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."

Studies on GS-6207 presented at IAS 2019 include:

Poster LBPEB13: Safety and antiviral activity over 10 days following a single dose of subcutaneous GS-6207, a first-in-class, long-acting HIV capsid inhibitor in people living with HIV

This ongoing Phase 1b trial randomized people living with HIV with no prior capsid inhibitor treatment to receive a single subcutaneous injection of GS-6207 (50 mg, 150 mg and 450 mg doses; n=6 per dose) versus placebo (n=6). The primary endpoint was maximum reduction of HIV-1 RNA through 10 days of treatment. In each dose group, mean maximum reduction in HIV-1 RNA by day 10 ranged from 1.8 to 2.2 log₁₀copies/mL, which were all significantly greater compared with placebo (all p<0.0001). No participant experienced a serious adverse event or discontinued due to adverse events. The most common adverse events were mild to moderate reactions at the injection site (63 percent; 15 of 24), all of which were self-limiting.

“This study provides the first clinical evidence that HIV capsid inhibition can lead to a significant decline in viral load and supports further evaluation of GS-6207 as a component of an effective antiretroviral regimen. In addition, a long-acting regimen can help some people living with HIV by reducing the burden of daily pill taking,” said Eric Daar, MD, Chief, Division of HIV Medicine at Harbor-UCLA Medical Center and lead study author. “These early trial results support advancing GS-6207 into the next phase of clinical development to understand its role as part of long-acting HIV therapy.”

Poster TUPEA075: In vitro resistance profile of GS-6207, a first-in-class picomolar HIV capsid inhibitor in clinical development as a novel long-acting antiretroviral agent

This in vitro study evaluated the emergence of resistance to GS-6207 in HIV-infected cells for the first time. At subtherapeutic concentrations, GS-6207 selected for L56I, Q67H, N74D/S or T107N mutations in HIV capsid. Virus containing one or more of these capsid mutations showed reduced susceptibility to GS-6207 but remained fully susceptible to other antiretroviral classes. GS-6207-selected variants occurred at highly conserved capsid residues (94 to 100 percent) and were extremely rare (<1 percent) in viral isolates from treatment-naïve people living with HIV. In vitro resistance to GS-6207 was commonly associated with reduced infectivity and impaired replication capacity, highlighting the importance of capsid in the viral replication cycle.

GS-6207 is an investigational therapy and is not approved by any regulatory authority globally; its safety and efficacy have not been established. There is no cure for HIV or AIDS.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

For nearly 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing and additional studies of GS-6207. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

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