Alcobra Ltd. (ADHD) announced that it has started patient enrollment in a phase IIb study (n=60) on its lead candidate, metadoxine extended release (MDX.V). MDX is being developed for the treatment of fragile X syndrome.
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 Alcobra.
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 last month.
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, Shire (SHPG), 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 (ENDP) and United Therapeutics Corp. (UTHR). Both stocks hold a Zacks Rank #1 (Strong Buy).