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Global Blood Therapeutics Announces Completion of Safety Review by Independent Data and Safety Monitoring Board (DSMB) for Phase 3 HOPE Study in Sickle Cell Disease
Global Blood Therapeutics, Inc. (GBT) (NASDAQ:GBT) announced today that the independent Data and Safety Monitoring Board (DSMB) for the Phase 3 HOPE (Hemoglobin Oxygen Affinity Modulation to Inhibit HbS PolymErization) Study evaluating voxelotor (previously called GBT440) for the treatment of sickle cell disease (SCD), has completed its first scheduled clinical safety review. No drug-related serious or severe adverse events were reported in either of the voxelotor treatment arms (900 mg and 1500 mg), and there were no discontinuations due to adverse events. Based on this review, the DSMB did not identify safety concerns with voxelotor at either dose level across all patients dosed in the ongoing SCD clinical program, including adult patients in the Phase 3 HOPE Study and adolescent patients in the HOPE-KIDS 1 (GBT440-007) Study. Based on the available safety data to date, including at the high dose level of 1500 mg, the DSMB recommended that the pivotal study continue as planned and approved initiation of enrollment in adolescent patients age 12 to 17.
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