Alcobra Ltd. (ADHD) Reports Full Clinical Hold on IND Applications for MDX and Phase III MEASURE Study

September 29, 2016 7:26 AM EDT

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Alcobra Ltd. (Nasdaq: ADHD) announced that it has received verbal notice from the Division of Psychiatry Products of the U.S. Food and Drug Administration (FDA) that a full clinical hold has been placed on its Investigational New Drug (IND) applications for MDX in ADHD and Fragile X Syndrome. The clinical hold affects Alcobra’s ongoing Phase III clinical study of MDX in adult patients with ADHD, known as the “MEASURE” study.

Alcobra has not yet received written notice of the clinical hold from the FDA, however, based on verbal communications, the FDA indicated that the clinical hold is due to adverse neurological findings in a pre-clinical study. The FDA notification was not based on clinical safety data observed in the ongoing MEASURE study, which has enrolled nearly 500 subjects, or previous clinical studies involving MDX. Alcobra plans to work diligently with the FDA to seek the removal of the clinical hold.

Conference Call InformationAlcobra will host a conference call to discuss today’s announcement.

Thursday, September 29, 2016 @ 8:30 a.m. Eastern TimeDomestic: 855-469-0611International: 484-756-4341Passcode: 91332641Webcast:

Replays available through October 13, 2016Domestic: 855-859-2056International: 404-537-3406Passcode: 91332641

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