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Gilead Announces Investigational Long-Acting HIV-1 Capsid Inhibitor, Lenacapavir, Achieves Primary Endpoint in Phase 2/3 Study in Heavily Treatment-Experienced People Living With HIV

GILD | November 18, 2020

– CAPELLA Trial Results Support Further Study of Lenacapavir in People with Multidrug Resistant HIV-1 Infection Who are Failing Current Treatment Regimen –

Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the Phase 2/3 CAPELLA trial evaluating the company’s investigational, long-acting HIV-1 capsid inhibitor, lenacapavir, in heavily treatment-experienced people with multidrug resistant HIV-1 infection. The study found that 88% of participants receiving lenacapavir (n=21/24) experienced at least a 0.5 log 10 reduction in HIV-1 viral load by the end of 14 days of functional monotherapy as compared with 17% of those receiving placebo (n=2/12).

“Treatment options that address the complex needs of heavily treatment-experienced people living with multidrug resistant HIV remain a significant unmet need. Lenacapavir, a novel investigational capsid inhibitor that is being evaluated to be administered subcutaneously every six months, represents a potential substantial advance in the field of HIV treatment,” noted Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. “We look forward to sharing data from longer-term follow-up of CAPELLA study participants next year and submitting these data for regulatory approval.”

Lenacapavir is being developed as a component of a long-acting regimen in combination with other antiretroviral agents for the treatment of HIV-1 infection. If approved, lenacapavir would be the first HIV capsid inhibitor available for the treatment of HIV-1 infection. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multidrug resistance in combination with other antiretroviral drugs.

In CAPELLA, 36 adults with multi-class HIV drug resistance and a detectable viral load while on a failing regimen were randomized 2:1 to receive oral lenacapavir or placebo for 14 days, in addition to continuing their failing regimen (functional monotherapy). Of the 24 people randomized to the lenacapavir group, the median baseline viral load was 4.2 log 10 copies/mL and 67% had a CD4 count of less than 200 cells/uL. A statistically significant greater proportion of participants receiving lenacapavir met the primary endpoint of a viral load reduction of at least 0.5 log 10 copies/mL from baseline compared with those receiving placebo at the end of the 14-day functional monotherapy period (88% vs. 17%, p<0.0001). Additionally, the lenacapavir group achieved a statistically significant greater mean change in viral load versus the placebo group (-1.93 log 10 copies/mL vs. -0.29 log 10 copies/mL, p<0.0001).

Lenacapavir was generally safe and well-tolerated, with no serious adverse events related to study drug observed and no study drug discontinuations for any reason through the 14-day period, including no discontinuations due to adverse events. The most common adverse events observed in this portion of the study include injection site swelling (21%) and injection site nodules (17%), the majority of which were Grade 1 or 2 in severity.

“There is an urgent and critical need for innovative treatment options for people living with HIV who have limited treatment options and are not able to maintain virologic suppression on their current therapy, whether from challenges adhering to a complex regimen or HIV mutations that cause drug resistance,” said Edwin DeJesus, MD, FACP, FIDSA, Medical Director, Orlando Immunology Center. “The initial CAPELLA trial results demonstrate that lenacapavir led to a rapid decline in viral load in heavily treatment-experienced people with multidrug resistance living with HIV. This clinical response could potentially have an important impact on individual patients and public health.”

Additional data from the study will be presented at a future scientific conference.

Following the 14-day functional monotherapy period of the study, all participants are offered open-label lenacapavir added to an optimized background regimen. This ongoing maintenance period of the study is evaluating the subcutaneous administration of lenacapavir every six months as well as the safety and efficacy of lenacapavir in addition to an optimized background regimen at Weeks 26 and 52.

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not known. There is no cure for HIV or AIDS.

About Lenacapavir

Lenacapavir 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. In in vitro studies, lenacapavir interrupts multiple distinct stages of the viral lifecycle, potentially preventing the virus from becoming infectious and gaining access to uninfected cells.

The safety, efficacy and dosing of lenacapavir are being evaluated in multiple ongoing clinical studies. Data presented at AIDS 2020 from the ongoing Phase 1 study support subcutaneous every six-month administration of lenacapavir for both HIV treatment and prevention studies. During IDWeek 2020, the company announced the addition of a new study arm to the Women’s HIV Prevention Study evaluating the use of lenacapavir as an injectable PrEP option administered every six months. An additional lenacapavir for PrEP study in men who have sex with men and persons of trans experience is planned, with a projected trial initiation date of mid-late 2021.

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 more than 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.

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 clinical trials involving lenacapavir, and the possibility that Gilead may be unable to complete one or more of such trials on the currently anticipated timelines or at all. In addition, it is possible that Gilead may make a strategic decision to discontinue development of lenacapavir, or that FDA and other regulatory agencies may not approve lenacapavir, and any marketing approvals, if granted, may have significant limitations on its use. As a result, lenacapavir may never be successfully commercialized. 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 September 30, 2020, 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.

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