Phase II Results With Taisho's KE-298

Taisho Pharmaceutical of Japan has presented preliminary results from a Phase II trial of its new anti-rheumatoid arthritis drug KE-298 at the general meeting of the Japanese Inflamm-ation Society. The compound is described as a disease-modifying anti-rheumatic drug or DMARD. Final Phase II results are expected in 1995.

A total of 60 patients with chronic rheumatoid arthritis received doses of the oral drug ranging from 100mg/day to 200mg/day for 12 weeks, reports Pharma Japan. Researchers from Taisho and the Tokyo Women's Medical College's Institute of Rheumatology noted that patients receiving the drug showed significant improvements in the Lansbury index, which includes measures such as morning stiffness and erythrocyte sedimentation rates.

KE-298 is a prodrug of a similar structure to D-penicillamine, a DMARD which has a similar action to gold. The problem with D-penicillamine is that side effects are frequent and often lead to treatment discontinuation, so the drug is usually only used in severe, refractory cases of the disease and where there are troublesome features outside of the joints, such as vasculitis. As a prodrug, KE-298 is converted in the body to its active metabolite, KE-758, and it is hoped that this mechanism will enhance the specificity and improve the safety of the drug.