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Alcobra Ltd (ADHD) and Transition Therapeutics Inc (TTHI): Two Failed CNS Drug Trials

Two drugs directed at behavioral disorders failed mid-stage studies on Wednesday morning, said sponsors Alcobra Ltd (NASDAQ:ADHD) and Transition Therapeutics Inc (USA) (NASDAQ:TTHI), yet again highlighting the difficulty in developing drugs for disorders involving the Central Nervous System.

Transition Therapeutics, meanwhile, reported on Wednesday the failure of ELND2005 in a phase 2/3 Alzheimer’s Agitation and Aggression, citing “a greater than expected reduction in agitation and aggression observed in the placebo group.” The 350-patient study evaluated ELND005 over 12 weeks of treatment in patients with mild to severe Alzheimer’s who were experiencing at least moderate levels of agitation/aggression. The trial’s primary endpoint was the change from baseline in the Neuropsychiatric Inventory – Clinician scale of agitation and aggression. Transition offered few details but plans to present the full findings at a future medical conference.Comparing Transition’s press release to Alcobra’s, its clear which company is saving face.Alcobra said that a phase 2 clinical trial of its extended release metadoxine in Fragile X Syndrome did not meet the primary endpoint – six-week change on the inattentive subscale of the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS-IV). The same drug failed a mid-stage study in Attention Deficit Disorder last summer. Alcobra shares traded as high as $26 prior to the ADHD failure, and at $7.15 on Wednesday morning the stock is just below its summer-2013 IPO price of $8.00.

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