Gilead Presents Data on Investigational HIV-1 Capsid Inhibitor GS-6207 as a Potential Component of Long-Acting HIV Therapy
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.
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.
Greg Mann, Investors
Ryan McKeel, Media
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Asahi Kasei Providing Samples of Hyaluronic Acid Nanogel as a New Pharmaceutical Excipient5.8.2020 05:00:00 EEST | Press release
Asahi Kasei has established industrial manufacturing technology for hyaluronic acid (HA) nanogel* as a new pharmaceutical excipient, and is providing samples to prospective customers in order to commercialize the product. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200804005334/en/ Chemical structure and self-assembly of HA nanogel (Graphic: Business Wire) The Functional Additives Division of Asahi Kasei’s Specialty Solutions SBU supplies Ceolus™ microcrystalline cellulose to pharmaceutical manufacturers around the world for use as an excipient for drug tablets. The commercialization of HA nanogel would expand the product lineup by adding a drug delivery system (DDS) base material for injection formulations. HA nanogel is expected to improve the quality of life (QOL) for patients by enabling the low-toxicity solubilization of insoluble drugs, facilitating the formulation of biopharmaceuticals such as proteins and peptides
RoboSense 80 Laser-Beam LiDAR RS-Ruby Lite Is Officially for Sale, Early-Bird Price $12,8004.8.2020 21:00:00 EEST | Press release
RoboSense http://www.robosense.ai/, the leading provider of smart LiDAR sensor, today launched an 80 laser-beam 3D sensing LiDAR ready for customer delivery with early-bird price of $12,800 (limited offer till 31st August, 2020), and standard price of $15,800. The timing of announcing this favorable package also marks the company's 6-year anniversary. The performance of the RS-Ruby Lite is close to that of the 128 laser-beam LiDAR RS-Ruby, with a vertical angular resolution of 0.1 degrees and 160m@10% ranging ability (with the longest detection range of 230 meters), making it suitable to address medium-and-high-speed autonomous driving applications with a price much more affordable to accelerate the commercialization of smart and safe transportation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200804005578/en/ The RS-Ruby Lite’s on-vehicle road-test point cloud image (Photo: Business Wire) Inheriting The Superb Performanc
Andersen Global Enters Chile With the Addition of Two Collaborating Firms4.8.2020 16:30:00 EEST | Press release
Andersen Global enters the Chilean market through Collaboration Agreements with two Santiago-based firms: law firm Chirgwin Peñafiel and tax firm SPASA Consulting. The firms are in close partnership with each other and add depth and breadth to the organization’s Latin American platform as it continues its steady expansion. Founded in 2009, Chirgwin Peñafiel, led by Office Managing Partner Andrés Chirgwin, is a full-service law firm specializing in commercial and corporate law, M&A, energy, labor law and banking & finance. The firm works with a variety of corporate clients, being strongly focused on providing legal support to multinational companies with operations in Chile, while also assisting Chilean-based companies with local and international legal needs. Chirgwin Peñafiel has been recognized by IFLR1000, Leaders League and Best Lawyers. “Our firm is committed to delivering quality, comprehensive solutions to our local and international clients,” Andrés said. “Andersen Global’s cap
Lam Research and VELO3D Strike Strategic Agreement to Use Metal Additive Manufacturing Applications for Production of Semiconductor Capital Equipment4.8.2020 16:25:00 EEST | Press release
Digital manufacturing innovator VELO3D and Lam Research Corporation (Nasdaq: LRCX) today announced a joint development agreement that includes collaboration on novel materials and designs in metal additive manufacturing (AM) or 3D printing applications for the semiconductor industry. Lam plans to significantly increase the volume of parts produced by AM over the next five years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200804005187/en/ The VELO3D Sapphire 3D metal printer (Photo: Business Wire) Additive manufacturing allows transformation of the supply chain from production of parts typically manufactured by subtractive methods, to higher performance, innovative designs that enable agile supply chains to adopt Industry 4.0 principles. VELO3D will develop new metal alloys on its Sapphire® printer that are critical to Lam designs and technologies. Lam Capital will also invest an undisclosed amount in VELO3D. “Lam Researc
Latest Generation YellowScan Mapping Systems Rely on Velodyne Lidar Sensors to Meet Demanding Needs of Survey Professionals4.8.2020 15:00:00 EEST | Press release
Velodyne Lidar, Inc. today announced two new generation YellowScan mobile mapping systems use Velodyne’s lidar sensors to help achieve the high precision and accuracy needed in aerial 3D mapping. Velodyne’s powerful lidar sensors generate real-time georeferenced point cloud data that allows YellowScan systems to accurately measure and analyze an area so customers can avoid time-intensive, costly manual surveys. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200804005168/en/ The YellowScan Surveyor Ultra is a high density and long range mapping solution equipped with a Velodyne Ultra Puck™ sensor. (Photo: YellowScan) The YellowScan Surveyor Ultra is a high density and long range mapping solution equipped with a Velodyne Ultra Puck™ sensor and ideally suited for high speed unmanned aerial vehicles (UAV), such as VTOL and helicopter drones. The YellowScan Surveyor is the company’s lightest system – at 1.6 kg including the batte
Imricor Announces First Sales Collaboration With Philips4.8.2020 15:00:00 EEST | Press release
Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR) the worldwide leader in MRI-guided cardiac ablation products, is pleased to announce the first sales collaboration with Philips, a global leader in healthcare technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200804005317/en/ Imricor announces first sales partnership with Philips. (Photo: Business Wire) The sales collaboration provides Philips non-exclusive rights to re-sell Imricor’s Advantage-MR System, along with Philips’ industry-leading MRI scanners in European countries that recognize the CE mark. This agreement is the first such agreement signed by Imricor. Imricor’s Chair and CEO, Steve Wedan said: “This agreement is a major milestone for Imricor, allowing Philips to take the lead on driving iCMR lab adoption and enabling us to focus on supporting utilization, growing our portfolio of consumable devices and expanding our indications for use. In thi
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom