Abbott/La Jolla LJP 394

Executive Summary

Phase II/III clinical trial of LJP 394 for the treatment of lupus nephritis is halted. According to the data safety committee overseeing the trial, while preliminary results showed LJP 394 lowered circulating antibodies to double-stranded DNA in patients, the committee found it unlikely that LJP 394 would show a statistically significant reduction in renal flares, the primary endpoint. There are more than 200 patients currently enrolled. Both companies are conducting a review of the data which could take several months to complete, and are continuing a Phase II dose-ranging study for LJP 394 with 75 lupus patients. That study is expected to be completed by fall