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ARTICLE | Clinical News

Global Blood, FDA agree on Phase III design

October 24, 2016 7:00 AM UTC

Global Blood Therapeutics Inc. (NASDAQ:GBT) gained $2.50 (14%) to $20.25 in early after-hours trading Monday after it said it reached agreement with FDA concerning the design of the Phase III HOPE trial of GBT440 to treat sickle cell disease patients with at least one episode of vaso-occlusive crisis in the previous year.

The study's first part will evaluate 900 and 1,500 mg GBT440 in about 150 patients, and the second part will evaluate GBT440 in 250 patients at a dose based on results from the trial's first part. The placebo-controlled trial's primary endpoint is the proportion of patients with a greater than 1 g/dL increase in hemoglobin at 24 weeks compared to baseline. Global Blood plans to start the trial by December, and expects top-line data in 1H19. ...