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news.GlaxoSmithKline and Shionogi & Co have completed an initial clinical study in humans with an investigational integrase inhibitor, 364735, which is being developed for the treatment of HIV/AIDS.
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Integrase inhibitors are a new class of anti-HIV drugs that block viral replication by preventing the virus from integrating into the genetic material of human immune cells. The integrase enzyme is unique to the virus and is not found in humans, which makes it an attractive drug target.
364735 is being developed by a joint venture between GSK and Shionogi. A phase I study of 364735 was recently conducted in the US to assess safety and pharmacokinetics in healthy volunteers. Results from this clinical trial will be submitted for presentation at an upcoming medical conference in 2007.
Data from this study of 364735 has enabled selection of doses for a phase II study, the next step in the drug candidate’s clinical development, which is planned to start in late 2006 in HIV-infected adults.
“Integrase continues to be an important target in the search for new treatments to address HIV/AIDS,” commented Dr Isao Teshirogi, director of the board and senior executive officer responsible for R&D at Shionogi. “Shionogi remains committed to discovering and advancing new drug candidates in this area, and we look forward to further progress with 364735.”