Israeli biopharmaceutical company Alcobra has filed an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to start a Phase III clinical trial with its proprietary drug candidate MG01CI (Metadoxine extended-release).
MG01CI is intended for the treatment of cognitive dysfunctions such as attention deficit hyperactivity disorder (ADHD) and Fragile X syndrome.
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The trial is entitled ‘A 6-week Randomized, Multicenter, Double-blind, Parallel, Fixed-dose Study of MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg Compared with Placebo in Adults with Attention Deficit/Hyperactivity Disorder (ADHD)’.
The principal investigator of the trial will be Dr Richard Weisler, an adjunct professor of psychiatry at the University of North Carolina (UNC) Chapel Hill School of Medicine, and adjunct associate professor of psychiatry and behavioral sciences at Duke University Medical Center in Durham, North Carolina.
According to the company, around 20 additional clinical sites in the US and Israel will also participate in the Phase III clinical trial.
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Alcobra president and chief executive officer Yaron Daniely said: "Given the positive results in our two previous Phase II studies in adults with ADHD, we look forward to working closely with the FDA to meet the remaining requirements necessary to bring this therapy to the market."
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By GlobalDataThe company is mainly focused on the development and commercialisation of MG01CI, which had recently completed Phase II trials for the treatment of ADHD.
MG01CI is an extended-release oral non-stimulant formulation of metadoxine, which is an ion-pair salt of pyridoxine (vitamin B6) and 2-pyrrolidone-5-carboxylate (PCA).
Pyridoxine is a precursor of coenzymes such as pyridoxal phosphate (PLP) and its dependent enzymes are necessary in the biosynthesis of four major neurotransmitters: serotonin, epinephrine, norepinephrine and gamma-aminobutyric acid (GABA).
Image: Alcobra’s Phase III trial of MG01CI is intended for the treatment of (ADHD) and Fragile X Syndrome. Photo: courtesy of Keerati / Freedigitalphotos.net.
