March 07, 2019
Gilead Announces Data From Two Studies Supporting Further Development of GS-6207, a Novel, Investigational HIV-1 Capsid Inhibitor as a Component of Future Long-Acting HIV Therapies
“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
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.
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.
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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
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Sung Lee, Investors
Ryan McKeel, Media