Health and Healthcare

Gilead Sciences Bounces on Preliminary Results

Chris Lange

Published: June 20, 2016 12:25 pm

Last Updated: January 13, 2020 6:36 am

Shares of Gilead Sciences Inc. (NASDAQ: GILD) saw make a handy gain just off of their 52-week low following the release of preliminary data from its HIV treatment. After the stock dropped about 17.5% so far in 2016, these positive results, although preliminary, could be what the company needs to rise off of these lows.

Early on Monday, this biotech giant announced data from four pre-clinical and Phase 1 studies evaluating bictegravir (GS-9883), a novel, unboosted, investigational once-daily integrase strand transfer inhibitor (INSTI). Overall, the studies examined the antiviral potency, resistance profile, pharmacokinetics and safety of bictegravir, and the results were presented this weekend during a poster session at the American Society of Microbiology (ASM) Microbe 2016 Conference in Boston.

Currently, bictegravir is in Phase 3 trials as part of a single tablet regimen in combination with tenofovir alafenamide (TAF) and emtricitabine (FTC) for the treatment of HIV-1 infection.

The data from the first Phase 1 human trial ultimately provided proof of concept for further evaluation of bictegravir as part of a single tablet regimen.

The company detailed the results as follows:

• The study examined the in vitro resistance profile of bictegravir compared to currently available INSTIs dolutegravir (DTG), elvitegravir (EVG) and raltegravir (RAL). Bictegravir demonstrated an improved resistance profile compared to DTG and a markedly improved profile compared to EVG and RAL against a panel of HIV integrase mutant viruses.
• Several INSTI candidates were tested for a range of properties including HIV-1 potency, metabolic stability, cytotoxicity and protein binding. Bictegravir was shown to be a potent INSTI with improved preclinical pharmacokinetics and an enhanced resistance profile compared to all currently available INSTIs—RAL, EVG and DTG.
• Twenty adults (19 male) with chronic HIV infection were treated with bictegravir (5, 25, 50 or 100 mg) or placebo once daily for 10 days to determine changes in HIV-1 RNA levels (viral load). Bictegravir was well tolerated at all dosing levels and provided rapid dose-dependent decreases in viral load that were sustained throughout the treatment period. There were no reports of primary resistance mutations in integrase, no serious adverse events (AEs) and no discontinuations due to AEs.
• The study analyzed in vitro antiviral activity of bictegravir alone and in combination with TAF, FTC and darunavir (DRV). Bictegravir alone was highly potent against HIV-1 infected target cells and demonstrated no antiviral effect against non-HIV viruses. In combination with TAF, FTC and DRV, bictegravir was highly synergistic against HIV-1. Bictegravir exhibited low cytotoxicity in non-target human cell lines.

Shares of Gilead were trading up 1.6% at $83.99 midday Monday, with a consensus analyst price target of $110.89 and a 52-week trading range of $81.28 to $123.37.