KEMIA COMPLETES THREE TRIALS OF KINASE INHIBITOR

Kemia has completed three Phase I clinical trials of KC706, an oral anti-inflammatory drug. The first escalating, single-dose study in healthy human volunteers showed that KC706 was well-tolerated. A second study evaluated the human pharmacokinetics of KC706 and demonstrated the safety of a range of doses to be used in Phase II clinical trials. The third Phase I trial confirmed the bioavailability of a capsule formulation to be used in future trials. A total of 79 healthy volunteers have received the drug to date.

KC706 may hold the potential to treat inflammatory conditions such as rheumatoid arthritis, psoriasis, asthma, chronic obstructive pulmonary disorder and certain metabolic and cardiovascular diseases. The company will soon begin a placebo-controlled Phase IIa trial in Europe in 150 patients with rheumatoid arthritis. The safety and efficacy of two doses of KC706 will be evaluated over a 12-week dosing period in patients who have evidence of active rheumatoid arthritis in spite of ongoing therapy with methotrexate.

KC706 is a selective, allosteric p38 MAP kinase inhibitor. The p38 protein is an important signaling molecule in inflammation. High levels of p38 activity have been associated with several inflammatory diseases. Additionally, the allosteric binding of KC706 to p38 MAP kinase results in a much longer duration of action compared with traditional ATP-competitive kinase inhibitors. This extended binding with the target protein provides the potential for once-daily dosing to have a more sustained therapeutic effect.