Gilead Sciences, Inc. (NASDAQ:GILD) today announced findings from two studies that support the further development of GS-6207, a novel, selective, first-in-class inhibitor of HIV-1 capsid function, for potential future use as part of long-acting HIV combination therapy. Interim blinded data from a Phase 1 study in healthy trial participants demonstrated that single doses of GS-6207 of up to 450 mg, administered subcutaneously, achieved sustained concentration levels and were well-tolerated. Separately, in vitro data demonstrated picomolar potency with GS-6207, including against HIV strains resistant to other antiretroviral (ARV) classes. The data were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle (Session O-06).
"These studies indicate that GS-6207, a first-in-class, investigational capsid inhibitor, may represent a novel approach to HIV treatment due to its long-acting characteristics and potent antiviral activity seen in vitro," said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. "The data presented at CROI support advancing GS-6207 to the next phase of clinical trials to gain a deeper understanding of its potential role as a long-acting agent for people living with HIV."
GS-6207 was evaluated in 40 healthy trial participants in an ongoing Phase 1 randomized, blinded, placebo-controlled, safety, tolerability and PK study. The participants were randomized (4:1) in four staggered single dose escalation cohorts to receive GS-6207 (n=8/cohort) or placebo (n=2/cohort), at 30, 100, 300 or 450 mg. Through 20 weeks (30 mg cohort) to 4 weeks (450 mg cohort) of study, there were no deaths, serious adverse events (AEs) or Grade 3 or 4 AEs. Most AEs were mild (Grade 1) and resolved. PK parameters for the 30 mg and 100 mg cohorts have been estimated; analyses for the 300 mg and 450 mg cohorts are ongoing. The PK profile of subcutaneously administered GS-6207 is consistent with sustained delivery, supporting a dosing interval of at least 3 months at doses greater than 100mg.
The in vitro study evaluated the pharmacological profile of GS-6207 which demonstrated up to >100-fold greater potency than certain commonly prescribed ARVs and synergistic antiviral activity when combined with the ARVs tenofovir alafenamide, efavirenz, dolutegravir or darunavir. The in vitro study also demonstrated that GS-6207 retains full potency against a broad range of HIV-1 strains resistant to other ARV classes.
Gilead has initiated a Phase 1b study of GS-6207 in people living with HIV.
GS-6207 is an investigational therapy and not approved by any regulatory body 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 11.5 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. In addition, we may have difficulties conducting the Phase 1b clinical study of GS-6207 as currently anticipated. In addition, we may observe unfavorable results from additional studies GS-6207 and Gilead may make a strategic decision to discontinue development of GS-6207 if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. As a result, GS-6207 may never be successfully commercialized. 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 Annual Report on Form 10-K for the year ended December 31, 2018, 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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