Alcobra : First Patient Enrolled In Phase IIb Fragile X Study Of MDX

(RTTNews) - Alcobra Ltd. (ADHD), an emerging pharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate Metadoxine Extended Release or MDX, to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, announced Tuesday that the first patient has been enrolled in a Phase IIb Fragile X study of MDX.

The FDA granted "Orphan Drug" designation to Metadoxine in the treatment of Fragile X Syndrome in December 2013.

The Phase IIb Fragile X trial is a multi-center, randomized, placebo-controlled study and is being conducted in 11 clinical sites, primarily in the U.S. It is designed to investigate MDX for 6 weeks compared with placebo in 60 adolescent and adult subjects with Fragile X Syndrome.

The company stated that its goal is to complete patient enrollment and report top-line data in the fourth-quarter of 2014.

Fragile X Syndrome (FXS) is a genetic condition that causes intellectual disability, behavioral and learning challenges and various physical characteristics. Behavioral characteristics can include ADHD, autism and autistic behaviors, social anxiety, stereotypic movements, poor eye contact, sensory disorders and increased risk for aggression.

Fragile X Syndrome is the leading known genetic cause of autism, accounting for about 2-6% of cases.

According to the National Institutes of Health (NIH), approximately one in 4,000 males and one in 8,000 females have Fragile X Syndrome. The FDA has not approved any drugs specifically for the treatment of Fragile X Syndrome or its symptoms.