Virus World

Gilead will now initiate two new clinical trials, for both treatment-naïve and multi-drug resistant HIV-1.  Gilead has presented Phase I data from its trial of GS-6207, an investigational first-in-class inhibitor of HIV-1 capsid function. The data supports the drug’s further further development and potential role as a component in a long-acting HIV combination therapy.

The data, taken from two Phase I studies, demonstrates that GS-6207 has potent antiviral activity and a potential dosing interval of up to every six months, and that the drug is generally well tolerated. Additionally, the company stated that in vitro virology study results suggest the investigational therapy could potentially be used in a broad range of people living with HIV regardless of their treatment history. The successful 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, senior vice president, HIV and emerging viruses. “Based on these promising results, we look forward to initiating additional studies to evaluate GS-6207 in people living with HIV later this year.”

On the news, the company 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 II and Phase II/III study, for patients living with treatment-naïve and multi-drug resistant HIV-1, respectively.

Gilead Press Release available at:

https://www.gilead.com/news-and-press/press-room/press-releases/2019/11/gilead-presents-data-on-investigational-hiv-1-capsid-inhibitor-gs-6207-as-a-potential-component-of-long-acting-hiv-therapy

Gilead Presents Proof-of-Concept Data for GS-6207, a First-in-Class Capsid Inhibitor, in People Living With HIV.

Gilead Sciences, Inc. (NASDAQ: GILD) today presented the first clinical data in people living with HIV on GS-6207, an investigational, novel, selective, first-in-class inhibitor of HIV capsid function. The Phase 1b data demonstrate the first proof of concept that HIV capsid inhibition can lead to significant declines in viral load in vivo. In addition, Gilead presented preclinical data demonstrating that resistance to GS-6207 in vitro did not lead to resistance to other classes of drugs used in the treatment of HIV. These data were presented at the 10thInternational AIDS Society Conference on HIV Science (IAS 2019) in Mexico City.

GS-6207 is an investigational long-acting antiretroviral agent that can be delivered subcutaneously. GS-6207 recently received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) as a potential therapy for heavily treatment-experienced people living with multi-drug resistant HIV. GS-6207 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. GS-6207 may interrupt multiple distinct stages of the viral lifecycle, potentially preventing the virus from becoming infectious and gaining access to uninfected cells.