Alcobra misses efficacy endpoint in ADHD trial

Alcobra's ($ADHD) attention deficit hyperactivity disorder (ADHD) drug MDX has failed to statistically outperform the placebo in a Phase II trial. The outcome meant the trial missed its secondary efficacy endpoint, but Alcobra did its best to talk up the significance of the positive safety data.

Alcobra CEO Yaron Daniely

Tel Aviv, Israel-based Alcobra made safety and tolerability the primary endpoint of the 83-person clinical trial and spent the first 240 words of its press release discussing how the side effect profile of MDX compared favorably to the placebo. But a 20-word sentence buried two-thirds of the way down the release could have more impact on the odds of MDX proving to be a success. MDX was no better than placebo at improving patients' scores on the Test of Variables of Attention (TOVA) assessment.

Alcobra picked out an "efficacy signal" in the TOVA omission errors and response times--the ADHD assessment's most important metric--as positives in the data. When coupled to the safety data, this was enough to have Alcobra hailing the trial as a success. "The successful completion of this safety study is an important milestone in the development of MDX and supports our ability to advance into efficacy trials of MDX for pediatric ADHD," Alcobra CEO Dr. Yaron Daniely said in a statement.

The pediatric ADHD indication is one of several being pursued by Alcobra. Last year's Phase III failure dented hopes of developing MDX as a treatment for adult ADHD but Alcobra plans to try again using some of the $27.9 million (€26.2 million) it raised in January. And data from a study of MDX in adults and children with Fragile X syndrome are due in the second quarter.

- read the release

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