Alcobra Ltd.
ADHD, an emerging biopharmaceutical company primarily focused on the
development and commercialization of its proprietary drug candidate Metadoxine
Extended Release (MDX), to treat cognitive dysfunctions, such as ADHD and
Fragile X Syndrome, today announced that it has submitted a protocol to the
FDA for a Phase IIb clinical trial for its MDX product candidate for the
treatment 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 protocol
submission is under an IND and is supported by strong, positive data collected
from multiple earlier pre-clinical trials on metadoxine. Results from these
studies demonstrated significant improvement in behavioral and cognitive
outcomes based on evaluations of memory, learning, and social interaction.
Furthermore, in a validated mouse model of Fragile X Syndrome, metadoxine
treatment was shown to result in improved levels of certain Fragile
X-associated blood and brain biological markers that may have a role in
learning and memory, while simultaneously reducing the number of immature
brain connections and levels of abnormally increased protein. In December
2013, the FDA granted "Orphan Drug" designation to Metadoxine in the treatment
of Fragile X Syndrome.
Elizabeth M. Berry-Kravis, MD, PhD, Professor of Biochemistry, Neurological
Sciences and Pediatrics at Rush University Medical Center in Chicago, Illinois
and Principal Investigator in this study commented, "Patients with Fragile X
Syndrome currently have limited treatment options, with no FDA approved
medications. The positive findings reported from the preclinical studies,
together with information that is known on the mechanism of action of
metadoxine, suggest that MDX may be helpful in treating cognitive symptoms in
these patients. This Phase IIb study should provide us with important insights
into the potential role of MDX in this condition."
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