UPDATE: Alcobra Issues Protocol to FDA for Phase IIb Study of Metadoxine ER for Treatment of Fragile X Syndrome

Alcobra Ltd.(Nasdaq: ADHD), an emerging biopharmaceutical company primarily focused on thedevelopment and commercialization of its proprietary drug candidate MetadoxineExtended Release (MDX), to treat cognitive dysfunctions, such as ADHD andFragile X Syndrome, today announced that it has submitted a protocol to theFDA for a Phase IIb clinical trial for its MDX product candidate for thetreatment of patients with Fragile X Syndrome.The planned Phase IIb MDX clinical trial will be a multi-center, randomized,placebo-controlled study, conducted primarily in the US. The protocolsubmission is under an IND and is supported by strong, positive data collectedfrom multiple earlier pre-clinical trials on metadoxine. Results from thesestudies demonstrated significant improvement in behavioral and cognitiveoutcomes based on evaluations of memory, learning, and social interaction.Furthermore, in a validated mouse model of Fragile X Syndrome, metadoxinetreatment was shown to result in improved levels of certain FragileX-associated blood and brain biological markers that may have a role inlearning and memory, while simultaneously reducing the number of immaturebrain connections and levels of abnormally increased protein. In December2013, the FDA granted "Orphan Drug" designation to Metadoxine in the treatmentof Fragile X Syndrome.Elizabeth M. Berry-Kravis, MD, PhD, Professor of Biochemistry, NeurologicalSciences and Pediatrics at Rush University Medical Center in Chicago, Illinoisand Principal Investigator in this study commented, "Patients with Fragile XSyndrome currently have limited treatment options, with no FDA approvedmedications. The positive findings reported from the preclinical studies,together with information that is known on the mechanism of action ofmetadoxine, suggest that MDX may be helpful in treating cognitive symptoms inthese patients. This Phase IIb study should provide us with important insightsinto the potential role of MDX in this condition."