ViiV and Janssen to test new HIV regimen in Phase III trial
pharmafile | January 7, 2016 | News story | Manufacturing and Production, Medical Communications, Research and Development | Edurant, HIV, Janssen, ViiV Healthcare, cabotegravir, collaboration, phase III, rilpivirine
Janssen has formalised its collaboration with ViiV Healthcare on the Phase III development and commercialisation of a two-drug regimen to treat HIV infection.
The companies will study the combination of two long acting, all-injectable formulations of Janssen’s reverse transcriptase inhibitor Edurant (rilpivirine) and ViiV’s cabotegravir.
Janssen and ViiV have been working for several years on bringing this regimen to market, and if successful, it could be the first-available long-acting, all-injectable two drug regimen for HIV.
The latest agreement for Phase III development, will be led by ViiV – a company part-owned by GSK and Pfizer – with Janssen supporting. The companies will both manufacture and supply individual drug formulations – if Phase III is successfully completed and regulators approve the regimen.
“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 at Johnson & Johnson and worldwide chairman, of anssen 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.”
The regimen has already shown promise in an ongoing Phase IIb study. At week 32, when given every four or eight weeks, it showed comparable efficacy to a daily oral regimen of three HIV medicines (investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs)).
If the product is successfully brought to market, it would offer people living with HIV who are virologically suppressed an alternative option from the standard oral three-drug daily regimen.
“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,” says 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.”
The companies are already collaborating on another HIV maintenance combination therapy. In May 2015, a Phase III programme was begun, testing Edurant and Tivicay (dolutegravir) as a two-drug, single-tablet regimen.
Since the beginning of the HIV epidemic, almost 75 million people have been infected with the virus. An estimated 35 million people are currently living with HIV globally, with 2.5 million people becoming newly infected each year.
Joel Levy
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