Two drugs directed at behavioral disorders failed mid-stage studies on Wednesday morning, said sponsors Alcobra (ADHD) and Transition Therapeutics (TTHI), yet again highlighting the difficulty in developing drugs for disorders involving the Central Nervous System.
The Alcobra (ADHD) 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.
Alcobra plugged metadoxine’s effect on two secondary endpoints as positive takeaways from the study, but the drug failed all other endpoints, including the primary where the placebo arm actually outperformed the drug. The company plans to meet with the FDA to determine next steps forward.
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.
