Business Wire

Gilead Presents Data on Investigational HIV-1 Capsid Inhibitor GS-6207 as a Potential Component of Long-Acting HIV Therapy

Share

Gilead Sciences, Inc. (NASDAQ:GILD) today announced data on GS-6207, an investigational, novel, selective, first-in-class inhibitor of HIV-1 capsid function, that support its further development and potential role as a component in long-acting HIV combination therapy. New data from two Phase 1 studies demonstrate that GS-6207 has potent antiviral activity and a potential dosing interval of up to every six months. In both clinical studies, GS-6207 was generally well tolerated and no serious adverse events were reported. Additional in vitro virology study results suggest GS-6207 can potentially be used in a broad range of people living with HIV regardless of their treatment history. These data were presented at the 17th European AIDS Conference (EACS) in Basel, Switzerland.

“These data reinforce the potential of HIV capsid inhibition as a new long-acting therapeutic pathway to achieving durable viral suppression and support further clinical development of GS-6207,” said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. “Based on these promising results, we look forward to initiating additional studies to evaluate GS-6207 in people living with HIV later this year.”

Gilead will be initiating enrollment of two new clinical trials of GS-6207 in combination with other antiretroviral agents in people living with HIV – a Phase 2/3 study (NCT03739866) in heavily treatment-experienced people living with multidrug resistant HIV-1, as well as a Phase 2 study (NCT04143594) in treatment-naïve people living with HIV. GS-6207 will be administered via a two-week oral lead-in, followed by a subcutaneous injection every six months.

“Long-acting HIV therapy is an exciting approach that could offer more convenience for people living with the disease who prefer not to take a daily pill,” said Eric Daar, MD, Chief of Division of HIV Medicine, Lundquist Institute at Harbor-UCLA Medical Center. “The potency and safety profiles of GS-6207, as demonstrated so far in research and early stage clinical trials, show its potential as a core component of a future long-acting HIV therapy.”

Data on GS-6207 presented at EACS 2019 include:

  • Safety and PK of subcutaneous of GS-6207, a novel HIV-1 capsid inhibitor (oral presentation PS13/1)

In this Phase 1 study, 40 healthy participants were randomized to receive either subcutaneous GS‑6207 at doses of 30, 100, 300 or 450 mg (n=8 for each cohort), or placebo (n=8). GS-6207 was generally safe and well tolerated. The most common AEs were injection site erythema (47 percent) and pain (38 percent), all of which were mild and resolved in a few days. The PK profile was characterized by prolonged exposure, with measurable concentrations for at least 32 weeks. These data suggest that GS-6207 may have a potential to be administered up to every six months.

  • Single doses of long-acting capsid inhibitor GS-6207 administered by subcutaneous injection are safe and efficacious in people living with HIV (poster PE3/17)

This is an ongoing double-blind, placebo-controlled, proof-of-concept Phase 1b study in people living with HIV who are capsid inhibitor-naïve. Participants were randomized to receive either a single dose of GS-6207 (20, 50, 150 or 450 mg) administered subcutaneously (n=6 for each cohort) or placebo (n=2 for each cohort). The primary endpoint was maximum reduction of HIV-1 RNA through 10 days of treatment. Across 20 to 450 mg cohorts, mean maximum reduction in HIV-1 RNA by Day 10 ranged from 1.4 to 2.2 log10copies/mL; these reductions were all significantly greater than those observed in the placebo groups (all p<0.0001). In the blinded review of safety data, GS-6207 was generally safe and well tolerated. The most common AEs were injection site pain (41 percent) and erythema (28 percent), all of which were mild or moderate and resolved in a few days.

  • HIV-1 from antiretroviral-naïve and experienced patients lack capsid substitutions associated with GS-6207 in vitro resistance (poster PE13/15)

In this analysis, a database of samples from 1,500 people living with HIV, including treatment-naïve (n=500), treatment-experienced but protease inhibitor (PI)-naïve (n=500) and treatment-experienced with PI failure with or without major PI resistance mutations (n=500), was screened for the presence of capsid mutations associated with in vitro resistance to GS-6207 (L56I, M66I, Q67H, K70N, N74D, N74S and T107N). None of the seven GS-6207 resistance mutations was detected among the patients studied. These results suggest a very low likelihood (<1 in 1500) of pre-existing resistance mutations against GS‑6207 among people living with HIV.

  • Absence of naturally existing resistance against the HIV-1 capsid inhibitor GS-6207 in HIV-1 primary isolates (poster PE13/22)

This study assessed the potency of GS-6207 in HIV-1 primary isolates with naturally occurring gag polymorphisms, which could be associated with loss of potency. The HIV-1 isolates were sourced from 51 people living with HIV, including treatment-naïve (n=15) and treatment-experienced (n=36) people. GS-6207 displayed high potency, with an EC50 of 95 pM, that was not affected by the presence of gag polymorphisms and/or PI resistance mutations. This result demonstrates the absence of naturally occurring resistance against GS-6207 in this sample of both treatment-naïve and treatment-experienced 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 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 that we may not be able to complete the additional clinical studies of GS-6207 in the currently anticipated timelines or at all. There is also the possibility of unfavorable results from additional studies of 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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.

Contact information

Greg Mann, Investors
(424) 322-1795

Ryan McKeel, Media
(650) 377-3548

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Universal Peace Federation: 70 Years After the Korean War World Leaders Call for Peace at Online Rally of Hope24.11.2020 19:19:00 CETPress release

Millions of viewers tuned into hundreds of broadcast stations and gathered online to call for peace among and between nations at the third Rally of Hope sponsored by the Universal Peace Federation (UPF) in Korea on Sunday, Nov. 22. UPF was founded in 2005 by Rev. Dr. Sun Myung Moon and Dr. Hak Ja Han Moon and is an NGO in General Consultative Status with the United Nations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201124005906/en/ Dr. Hak Ja Han Moon addresses live audience and online participants from all around the world at the Rally of Hope (Photo: Business Wire) Mrs. Moon announced two new projects: to set up Korean War memorials in those nations that do not yet have them and create an online registry of all those who sacrificed in any way to support Korea during its darkest hour. “All around the world, unforeseen and unexpected challenges are erupting in the realms of politics, economy and religion” she said. “We

Verimatrix Chief Revenue Officer Named to SportsPro OTT Summit Advisory Board24.11.2020 17:45:00 CETPress release

Regulatory News: Verimatrix, (Paris:VMX) (Euronext Paris: VMX), the leader in powering the modern connected world with people-centered security, today announced that Lu Bolden, Chief Revenue Officer, was named to the SportsPro OTT Summit Advisory Board, the group that shapes one of world’s most prominent sports broadcasting annual events. The second annual event takes place December 2-3, 2020. Organized by SportsPro Media, this year’s virtual SportsPro OTT Summit is the preeminent venue for learning the latest in strategy, content and technology trends in the sports broadcasting market. The OTT Summit Advisory Board reads as a who’s who of the digital sports broadcasting realm, including executives from the UFC, NFL, MotoGP, Fox Sports, DAZN, PGA Tour, Canal+, Formula One, NBC Sports and the International Olympic Committee. Bolden brings to the group the needed expertise in how to easily deliver excellent fan experiences on any device while also securely scaling during popular live eve

ender diagnostics Receives FDA Notification for Rapid and Reliable COVID-19 Tests24.11.2020 15:41:00 CETPress release

The two ender COVID-19 tests received the FDA notification, marking the entry of the Swiss company into the US market. With the continued surge of COVID-19 cases in the US, the American subsidiary of ender diagnostics, ENDER DIAGNOSTICS NORTH AMERICA, is ready to deliver rapid and reliable COVID-19 testing kits to diagnostic laboratories wishing to increase their testing capacities. The company is proud to be actively contributing to successfully manage the pandemic. The ender products are highly accurate and fast, allowing laboratories to increase their throughput significantly. ender LAB and ender MASS arein-vitro diagnostic test kits based on a rapid molecular isothermal nucleic acid amplification technology. Both ender LAB and ender MASS are designed for use by laboratory professionals or trained operators on standard real-time PCR devices. For ender LAB, the result is provided within 30 minutes after the extraction of the viral RNA, which makes it significantly faster than typical

LBC Tank Terminals Holding Netherlands B.V. Announces Q1 FY21 Financial Results Conference Call24.11.2020 15:06:00 CETPress release

LBC Tank Terminals announced today that a conference call will be held to discuss the company’s financial results for Q1 FY21 which ended on 30 September 2020. The results will be published today, Tuesday 24 November 2020, followed by a conference call for all investors on Tuesday, 1 December 2020 at 16:00 (Central European Time) / 10:00 (Eastern Standard Time). Call details and copies of the financial statements will be made available on the Intralinks website. Investors of LBC Tank Terminals Holding Netherlands B.V. Senior Notes, due 2023, can request access to Intralinks by contacting investors@lbctt.com. LBC Tank Terminals LBC Tank Terminals, with its headquarter in Belgium, is an independent operator of midstream and downstream bulk liquid storage facilities for chemicals, oils and refined petroleum products currently owning and operating seven terminals located in Houston, Freeport, Baton Rouge, Antwerp and Rotterdam with combined storage capacity of 2.6 million m³, serving over

BentallGreenOak’s Global Real Estate Investment Platform Receives Top Accolades in the 2020 Global Real Estate Sustainability Benchmark (GRESB), Marking 10 Years of Leadership in ESG24.11.2020 15:00:00 CETPress release

BentallGreenOak (BGO) announced today that its global real estate investment platform has again achieved top global rankings in the annual Global Real Estate Sustainability Benchmark (GRESB). The 2020 rankings mark the 10th straight year of outstanding leadership in ESG worldwide for BGO. The firm’s increased focus on asset resilience as an important element in its investment management strategy for its clients has resulted in several BGO accounts being ranked 1st overall in the world out of 412 participants in GRESB’s Resilience Module. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201124005284/en/ The BGO Diversified US Property Fund continued its leadership streak from 2019, ranking 1st in the U.S. Diversified, Core peer group, 2nd overall in the Americas, Diversified sector and 4th globally for the Diversified, Non-listed, Core peer group. The Sun Life General Account scored its best result ever, placing 2nd in Canada a

Digital Storytelling Platform ALEXANDER Launches with All-Star Cast24.11.2020 15:00:00 CETPress release

Alexander is the digital home of original non-fiction stories from around the world. Bringing together some of the world’s most respected creative talent, Alexander’s feature stories are commissioned from acclaimed global authors and journalists and give unique access to fascinating places, cultures and people. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201124005565/en/ Using the Alexander mobile app, every original feature is presented in multiple storytelling dimensions—a commissioned written story, an audio performance and a super short film. The crafted film introduces the setting, teases the subject and sets the mood. Audiences then transition into the full story and can read, listen or move seamlessly via The Toggle, a proprietary text-to-audio functionality, between the written word and the audio performance. The convergence creates an immersive storytelling experience that meets the high expectations of discernin