CORK, Ireland, January 7, 2016 /PRNewswire/ --
Results from ongoing phase IIb Week 32 study show that if successfully developed and approved, people living with HIV could potentially maintain viral suppression
Janssen Sciences Ireland UC (Janssen), today formalized its collaboration with ViiV Healthcare on phase III development and commercialization of a two drug regimen of two long acting, all-injectable formulations of rilpivirine (a non-nucleoside reverse transcriptase inhibitor by Janssen) and cabotegravir (ViiV Healthcare).
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Janssen and ViiV Healthcare have been working together on this regimen, through a number of clinical trial agreements, for several years. Under this new agreement, the phase III development, to evaluate the efficacy, safety and tolerability of the regimen, will be led by ViiV Healthcare with support from Janssen. Each company will manufacture and supply their individual drug formulations following successful phase III completion and regulatory outcomes.
"Despite great progress in developing HIV treatments, the day-to-day burden of managing HIV remains high and poses challenges to ensure people living with HIV maintain an undetectable viral load," says Paul Stoffels, Chief Scientific Officer, Johnson & Johnson and Worldwide Chairman, Janssen Pharmaceutical Companies. "We are committed to making a real difference for those affected by HIV. The prospect of developing new therapies, such as long acting formulations which are broadly accessible, may offer hope to the many millions affected by HIV around the world."
At week 32, in an ongoing phase IIb study (LATTE 2, NCT02120352), the investigational long acting, all-injectable combination regimen, given every 4 or 8 weeks, showed comparable efficacy to a daily oral regimen of three HIV medicines (investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs)). If successfully developed and approved by regulatory authorities, people living with HIV who are virologically suppressed could be offered an alternative option to the standard oral daily regimen* of three drug therapy.
"While we work toward our long-term goal of developing a preventative HIV vaccine, we are excited to be able to continue to support people living with HIV through innovative improvements," said Wim Parys, Head of R&D, Global Public Health, Janssen. "Through this collaboration, we have the potential to develop the first long acting, all-injectable two drug regimen as an innovative option for HIV maintenance therapy."
Since the beginning of the HIV epidemic, almost 75 million people have been infected with the virus. It is estimated that 35 million people are currently living with HIV globally, with 2.5 million people becoming newly infected each year.
*Standard three drug oral therapy contains three active components taken daily: a backbone of two NRTIs, plus either a non-nucleoside reverse transcriptase inhibitor, a protease inhibitor (PI) or an integrase inhibitor (INI).
More information on the Phase IIb LATTE 2 study
LATTE 2 was initiated as a phase IIb, multicentre, open label, 96 week study investigating the safety and efficacy of this first all-injectable long acting combination regimen of rilpivirine and cabotegravir to maintain suppression of viral load. LATTE 2 included adults (n=309) who, after reaching virologic suppression on oral therapy with once-daily investigational oral cabotegravir 30mg + 2 NRTIs (n=286, 93%), were subsequently randomized to one of three study arms to receive either CAB LA + RPV LA injections every 4 weeks (n=115, Q4W), 8 weeks (n=115 Q8W) or continued on oral CAB + NRTIs (n=56).
Viral suppression rates (plasma HIV-1 RNA