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Alcobra's Fragile X Drug Fails Mid-Stage Trial


June 24, 2015

By Reuters Staff

Israel-based Alcobra Ltd said its drug failed in a mid-stage trial to treat a type of genetic disorder that could cause autism and attention deficit hyperactivity disorder.

Alcobra said the drug MDX (metadoxine extended release) for treatment of fragile X syndrome did not meet its main goal of change from baseline to week six of the inattentive subscale of the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS-IV). The difference between the MDX and placebo groups was not statistically significant.

However, MDX did achieve statistical significance, in the Intent-to-Treat (ITT) population, on two secondary endpoints, including the Vineland Adaptive Behavior Scale (VABS) Daily Living Skills Domain (p=0.044), and the computerized cognitive Test of Attentional Performance for Children (KiTAP) Distractibility subscale (p=0.017).

In the study, MDX was generally well tolerated and no safety concerns were identified.

Alcobra said it plans to discuss the trial results with the U.S. Food and Drug Administration before finalizing the design of the next study.

The drug is currently in late-stage trial to treat ADHD in adults and in mid-stage trial to treat the same in pediatric patients.

MDX received orphan drug status in 2013 for treatment of fragile X syndrome.

According to the National Institutes of Health, about 50,000 Americans are affected by fragile X syndrome that can lead to behavioral and learning challenges. There are currently no approved medications to treat fragile X syndrome.

 

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