Human Genome Sciences shares plunged in early trading today after the Rockville, Maryland-based biotech reported that its experimental lupus drug, LymphoStat-B, failed to hit primary endpoints in a mid-stage trial. Researchers reported that the drug appeared safe and well tolerated and showed signs of clinical effect. But the drug failed to reduce symptoms at the 24th week or delay the first instance of onset past 52 weeks. The drug did achieve statistical significance for a subset of seropositive patients, which accounts for 75 percent of the enrolled population. That is likely to bear heavy influence on the design of HGS' Phase III trial, which is now being planned.
"I am encouraged by the substantial evidence of LymphoStat-B's clinical activity that has emerged from this Phase 2 trial in patients with systemic lupus erythematosus," said David C. Stump, M.D., Executive Vice President, Drug Development. "The statistically significant clinical effect of LymphoStat-B in the seropositive subpopulation is interesting, given the greater disease activity that is observable in these patients, who represent 75 percent of the study's patient population."
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