HGS unveils Ph III LymphoStat-B trial plan

USA-based drug developer Human Genome Sciences has announced the Ph III developmental protocol for trials of LymphoStat-B (belimumab) in patients with active systemic lupus erythematosus. The program, which has been designed in collaboration with UK drug major GlaxoSmithKline as well as experts in SLE, has been agreed with European and US regulatory authorities, and is expected to begin before the end of the year.

The proposed protocol includes two double-blind, placebo-controlled, multicenter Phase III trials that are designed to evaluate the product's safety, tolerability and efficacy when used in the treatment of SLE. The primary efficacy endpoint is defined as response rate at week-52 of the program.

The firm added that GSK's input, which results from the UK firm's exercising of an option under its 1996 agreement, will be to assist HGS in carrying out the study. HGS will receive a $24.0 million payment from GSK in the third quarter of the year with respect to the latter's right to co-develop the drug.