TEL AVIV, Israel I August 19, 2014 I Alcobra Ltd. (ADHD), an emerging pharmaceutical 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, announced today that the first patient has been enrolled in a Phase IIb Fragile X study of MDX. The FDA granted “Orphan Drug” designation to Metadoxine in the treatment of Fragile X Syndrome in December 2013.
The Phase IIb Fragile X trial is a multi-center, randomized, placebo-controlled study and is being conducted in 11 clinical sites, primarily in the U.S. It is designed to investigate MDX for 6 weeks compared with placebo in 60 adolescent and adult subjects with Fragile X Syndrome.
“We are pleased to start enrolling patients into our Phase IIb clinical study for MDX in Fragile X Syndrome,” said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. “Our interest in Fragile X Syndrome is based on a comprehensive data set demonstrating significant improvements in learning, social and cognitive functions in a pre-clinical model of the disease. In addition, data supporting MDX modulation of the GABA/glutamate circuit and its rapid and significant effect on attentional capabilities in the ADHD population suggest a potential benefit in the Fragile X population. Our goal is to complete patient enrollment and report top-line data in the 4th quarter of 2014.”
“We expect that this study will give us important insights into the efficacy and safety of MDX in Fragile X Syndrome,” said Elizabeth Berry Kravis, MD, PhD, Associate Professor of Biochemistry, Neurological Sciences, and Pediatrics at Rush University Medical Center, and the Principal Investigator of the Phase IIb study. “Fragile X Syndrome is a genetic condition that causes intellectual disability, and is the leading known genetic cause of autism. There are no approved treatments for Fragile X Syndrome, so the development of MDX in this indication has the potential to address a significant unmet need.”
About Fragile X Syndrome
Fragile X Syndrome (FXS) is a genetic condition that causes intellectual disability, behavioral and learning challenges and various physical characteristics. Behavioral characteristics can include ADHD, autism and autistic behaviors, social anxiety, stereotypic movements, poor eye contact, sensory disorders and increased risk for aggression. Fragile X Syndrome is the leading known genetic cause of autism, accounting for about 2-6% of cases. Fragile X Syndrome represents an unmet medical need and a rare disease, as defined by the Orphan Drug Act. According to the National Institutes of Health (NIH), approximately one in 4,000 males and one in 8,000 females have Fragile X Syndrome. The FDA has not approved any drugs specifically for the treatment of Fragile X Syndrome or its symptoms.
About Alcobra Ltd.
Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MDX (Metadoxine Extended Release (MG01CI)), to treat cognitive disorders including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome. MDX has completed multiple Phase II studies in adults with ADHD and has completed enrollment in a Phase III study in adults with ADHD. The company is conducting separate Phase IIb trials in pediatric ADHD and Fragile X Syndrome. The company was founded in 2008 and is headquartered in Tel Aviv, Israel. For more information please visit the Company’s website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference.
SOURCE: Alcobra
Post Views: 32
TEL AVIV, Israel I August 19, 2014 I Alcobra Ltd. (ADHD), an emerging pharmaceutical 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, announced today that the first patient has been enrolled in a Phase IIb Fragile X study of MDX. The FDA granted “Orphan Drug” designation to Metadoxine in the treatment of Fragile X Syndrome in December 2013.
The Phase IIb Fragile X trial is a multi-center, randomized, placebo-controlled study and is being conducted in 11 clinical sites, primarily in the U.S. It is designed to investigate MDX for 6 weeks compared with placebo in 60 adolescent and adult subjects with Fragile X Syndrome.
“We are pleased to start enrolling patients into our Phase IIb clinical study for MDX in Fragile X Syndrome,” said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. “Our interest in Fragile X Syndrome is based on a comprehensive data set demonstrating significant improvements in learning, social and cognitive functions in a pre-clinical model of the disease. In addition, data supporting MDX modulation of the GABA/glutamate circuit and its rapid and significant effect on attentional capabilities in the ADHD population suggest a potential benefit in the Fragile X population. Our goal is to complete patient enrollment and report top-line data in the 4th quarter of 2014.”
“We expect that this study will give us important insights into the efficacy and safety of MDX in Fragile X Syndrome,” said Elizabeth Berry Kravis, MD, PhD, Associate Professor of Biochemistry, Neurological Sciences, and Pediatrics at Rush University Medical Center, and the Principal Investigator of the Phase IIb study. “Fragile X Syndrome is a genetic condition that causes intellectual disability, and is the leading known genetic cause of autism. There are no approved treatments for Fragile X Syndrome, so the development of MDX in this indication has the potential to address a significant unmet need.”
About Fragile X Syndrome
Fragile X Syndrome (FXS) is a genetic condition that causes intellectual disability, behavioral and learning challenges and various physical characteristics. Behavioral characteristics can include ADHD, autism and autistic behaviors, social anxiety, stereotypic movements, poor eye contact, sensory disorders and increased risk for aggression. Fragile X Syndrome is the leading known genetic cause of autism, accounting for about 2-6% of cases. Fragile X Syndrome represents an unmet medical need and a rare disease, as defined by the Orphan Drug Act. According to the National Institutes of Health (NIH), approximately one in 4,000 males and one in 8,000 females have Fragile X Syndrome. The FDA has not approved any drugs specifically for the treatment of Fragile X Syndrome or its symptoms.
About Alcobra Ltd.
Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MDX (Metadoxine Extended Release (MG01CI)), to treat cognitive disorders including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome. MDX has completed multiple Phase II studies in adults with ADHD and has completed enrollment in a Phase III study in adults with ADHD. The company is conducting separate Phase IIb trials in pediatric ADHD and Fragile X Syndrome. The company was founded in 2008 and is headquartered in Tel Aviv, Israel. For more information please visit the Company’s website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference.
SOURCE: Alcobra
Post Views: 32
