23 July 2019 - - US-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) has 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 company said.
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 10th International 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 US Food and Drug Administration 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.
Studies on GS-6207 presented at IAS 2019 include:
Poster LBPEB13: Safety and antiviral activity over 10 days following a single dose of subcutaneous GS-6207, a first-in-class, long-acting HIV capsid inhibitor in people living with HIV
This ongoing Phase 1b trial randomized people living with HIV with no prior capsid inhibitor treatment to receive a single subcutaneous injection of GS-6207 (50 mg, 150 mg and 450 mg doses; n=6 per dose) versus placebo. The primary endpoint was maximum reduction of HIV-1 RNA through 10 days of treatment.
In each dose group, mean maximum reduction in HIV-1 RNA by day 10 ranged from 1.8 to 2.2 log10copies/mL, which were all significantly greater compared with placebo (all p