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news.Human Genome Sciences' investigational drug candidate LymphoStat-B has posted positive results in a phase II trial evaluating the drug in the treatment of the debilitating autoimmune disease, lupus erythematosus.
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According to results, presented by the company at the Annual European Congress of Rheumatology in Amsterdam, the compound significantly reduced disease activity, exhibited clinically relevant bioactivity, and was safe and well tolerated.
“The substantial evidence now available from our phase II clinical program clearly supports the phase III study of LymphoStat-B in patients with systemic lupus erythematosus,” said Dr David Stump, executive vice president, drug development, Human Genome Sciences.
The company will now move the compound into phase III development along with its collaborator GlaxoSmithKline. The initiation of the phase III trial is planned before the end of the year.
GlaxoSmithKline has exercised its option under a June 1996 agreement to develop and commercialize LymphoStat-B jointly with Human Genome Sciences.
Under the terms of the agreement, GSK and Human Genome Sciences will share equally in phase III/IV development costs, and will share equally in sales and marketing expenses and profits of any product that is commercialized under the agreement.