Jul 26 2004
Y's Therapeutics, a privately held biopharmaceutical company, said today it has submitted applications to the Ethics Committee and Ministry of Health (BfArM) in Germany to begin Phase II clinical trials for its two most advanced projects, YSIL6 for rheumatoid arthritis and YSTH2 for asthma.
Both studies are randomized, double-blind, placebo-controlled, dose-ranging, multi-national, multi-center trials, with the goal of obtaining substantial evidence of safety and efficacy for their respective indications.
The company also announced that it will establish two subsidiary companies: one in Germany to manage clinical studies in European countries and a second in the United States. Establishment of these subsidiaries will enable the company to take a vital step towards its planned full-scale global drug development. Y's Therapeutics also expects these operations to include business development and non-clinical & clinical development functions, as well as in-house lab function capability to enhance drug development.
"We recognized early on the importance of designing and conducting clinical trials on a very broad scale," stated Mr. Masanori Murayama, Co-founder, President and CEO of Y's Therapeutics. "By establishing a global clinical network, we can optimize and accelerate the clinical proof of concept stage for the drugs in development."
YSIL6 is a small-molecule drug in development for the treatment of inflammatory diseases, including rheumatoid arthritis and psoriasis. The molecule works by inhibiting TNF-alpha and IL-6 production in T-cells and macrophages, and by inhibiting T-cell proliferation and migration.
YSTH2 is a small-molecule drug in development for treatment of asthma and other diseases in which Th-2 type cytokine imbalance is suspected. The molecule works by inhibiting T-cell proliferation and migration, and by inhibiting Th-2 type and proinflammatory cytokine production, while exerting no effect on Th-1 type cytokine production.
Gut bacteria changes may foreshadow rheumatoid arthritis