ViiV Healthcare and Johnson & Johnson ($JNJ) are pressing into late-stage development with a combination HIV treatment that can be dosed every 8 weeks, building on clinical results in which their cocktail measured up to daily pills.
The injected therapy combines J&J's rilpivirine, marketed as Edurant, with ViiV's investigational cabotegravir. In a Phase IIb study disclosed last year, ViiV enrolled 309 HIV patients who had achieved viral suppression on oral therapies and split them into three groups: one staying on daily pills, one getting monthly shots of the combination therapy and one getting an every-8-weeks injection.
After 32 weeks, viral suppression rates stayed consistent across all three groups, ViiV said, with 95% in the 8-week group, 94% for monthly patients and 91% for those who stayed on oral therapy.
The results, presented at the Conference on Retroviruses and Opportunistic Infections this week, have convinced ViiV to map out a Phase III effort, and the company said it expects to start late-stage studies later this year.
"There continues to be a need for new HIV medicines, including those that could offer more flexible dosing regimens for people living with HIV," ViiV Chief Scientific Officer John Pottage said in a statement. "The LATTE-2 study results provide the first evidence that a long-acting, two-drug injectable regimen may offer an alternative to daily oral three-drug therapy for people who have achieved viral suppression."
ViiV, which is majority-owned by GlaxoSmithKline ($GSK), has been steadily raising its profile since getting off the ground in 2009 with help from Pfizer ($PFE) and Shionogi. The company has notched two FDA approvals since its formation and now contends with market leaders Gilead Sciences ($GILD) and J&J in the HIV space.
And ViiV is working to entrench itself in the market, last year signing a deal to buy Bristol-Myers Squibb's ($BMY) HIV pipeline for as much as $3 billion. Under the agreement, ViiV is paying $317 million up front for Bristol-Myers' two late-stage assets and $33 million for the early-phase pipeline, promising up to $1.1 billion more in development milestones and another $1.5 billion in royalties on future sales.
- read the statement