) announced that it has started patient enrollment in a phase IIb
study (n=60) on its lead candidate, metadoxine extended release
(MDX). MDX is being developed for the treatment of fragile X
The multi-center, randomized, placebo-controlled study will
evaluate MDX for 6 weeks in adolescents and adults suffering from
fragile X syndrome in comparison to placebo. Alcobra intends to
complete the study and report top-line results from the same in the
fourth quarter of this year.
The company stated in its press release that there are no approved
products in the market for the treatment of fragile X syndrome. As
a result, the approval of MDX will open up an untouched market for
We note that MDX is being developed for other indications as well.
Alcobra is currently evaluating MDX in a phase III study for the
treatment of adults suffering from attention deficit hyperactivity
disorder. The company completed patient enrolment for the study
Moreover, Alcobra is conducting a phase IIb study on MDX in
pediatric attention deficit hyperactivity disorder. Alcobra expects
top-line data from the study by the end of the year.
We are encouraged by the company's progress with MDX. Meanwhile,
), among others, has a strong presence in the attention deficit
hyperactivity disorder market. We expect investor focus to remain
on MDX going forward.
Alcobra holds a Zacks Rank #3 (Hold). Some better-ranked stocks in
the health care sector include Endo International (
) and United Therapeutics Corp. (
). Both stocks hold a Zacks Rank #1 (Strong Buy).
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