TEL AVIV, Israel I March 18, 2014 I Alcobra Ltd. (Nasdaq: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, announced today that, following the recent FDA acceptance of the Company’s IND for MDX, the first patient has been enrolled in a Phase 3 clinical trial of MDX in the treatment of Adults with ADHD.
“We are very pleased to have our US clinical program for MDX underway with the enrollment of our first patient in this clinical trial,” said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. “Building upon our two successful Phase II placebo-controlled studies, this Phase III study is designed to confirm MDX as a fast-acting, highly effective and well tolerated non-scheduled ADHD drug candidate. We expect the trial to be completed in the second half of 2014.”
“This study should give us important insights into the efficacy and safety of MDX in ADHD,” said Dr. Richard Weisler, adjunct professor of psychiatry at the University of North Carolina School of Medicine and adjunct associate professor of psychiatry at Duke University Medical Center. Dr. Weisler is the Principal Investigator of the study. “Up to 60% of people who have ADHD as children will continue to have significant ADHD symptoms that persist into adulthood. Thus, there remains a significant unmet need for additional treatments that are safe, effective, and preferably for many patients, non-addictive.”
The study is a 300-patient, randomized, placebo-controlled trial to be conducted at 20 sites in the United States and Israel. Patients will be randomized to receive either 1400 mg MDX or placebo over 6 weeks following a 2 week screening period. The primary endpoint is the Conners’ Adult ADHD Rating Scale (CAARS-INV), a widely accepted clinical measure of the presence and severity of ADHD symptoms. Secondary endpoints will include the computerized TOVA (Test of Variables of Attention) which was also used in the previous Phase 2 studies, as well as additional exploratory endpoints. More information about the trial can be found on ClinicalTrials.gov (Identifier: NCT02059642).
Unlike the most commonly prescribed ADHD medications, MDX is not a stimulant. MDX has a novel mechanism of action that neither targets dopamine nor norepinephrine. MDX has demonstrated significant efficacy and was generally well tolerated in two separate placebo-controlled Phase 2 studies in adults with ADHD. Additionally, MDX has demonstrated significant efficacy following the first dose.
About Alcobra Ltd.
Alcobra Ltd. is an emerging biopharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MDX (Metadoxine Extended Release (MG01CI)), to treat cognitive dysfunctions including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome. MDX has completed Phase II studies to treat Attention Deficit Hyperactivity Disorder. 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: 138
TEL AVIV, Israel I March 18, 2014 I Alcobra Ltd. (Nasdaq: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, announced today that, following the recent FDA acceptance of the Company’s IND for MDX, the first patient has been enrolled in a Phase 3 clinical trial of MDX in the treatment of Adults with ADHD.
“We are very pleased to have our US clinical program for MDX underway with the enrollment of our first patient in this clinical trial,” said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. “Building upon our two successful Phase II placebo-controlled studies, this Phase III study is designed to confirm MDX as a fast-acting, highly effective and well tolerated non-scheduled ADHD drug candidate. We expect the trial to be completed in the second half of 2014.”
“This study should give us important insights into the efficacy and safety of MDX in ADHD,” said Dr. Richard Weisler, adjunct professor of psychiatry at the University of North Carolina School of Medicine and adjunct associate professor of psychiatry at Duke University Medical Center. Dr. Weisler is the Principal Investigator of the study. “Up to 60% of people who have ADHD as children will continue to have significant ADHD symptoms that persist into adulthood. Thus, there remains a significant unmet need for additional treatments that are safe, effective, and preferably for many patients, non-addictive.”
The study is a 300-patient, randomized, placebo-controlled trial to be conducted at 20 sites in the United States and Israel. Patients will be randomized to receive either 1400 mg MDX or placebo over 6 weeks following a 2 week screening period. The primary endpoint is the Conners’ Adult ADHD Rating Scale (CAARS-INV), a widely accepted clinical measure of the presence and severity of ADHD symptoms. Secondary endpoints will include the computerized TOVA (Test of Variables of Attention) which was also used in the previous Phase 2 studies, as well as additional exploratory endpoints. More information about the trial can be found on ClinicalTrials.gov (Identifier: NCT02059642).
Unlike the most commonly prescribed ADHD medications, MDX is not a stimulant. MDX has a novel mechanism of action that neither targets dopamine nor norepinephrine. MDX has demonstrated significant efficacy and was generally well tolerated in two separate placebo-controlled Phase 2 studies in adults with ADHD. Additionally, MDX has demonstrated significant efficacy following the first dose.
About Alcobra Ltd.
Alcobra Ltd. is an emerging biopharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MDX (Metadoxine Extended Release (MG01CI)), to treat cognitive dysfunctions including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome. MDX has completed Phase II studies to treat Attention Deficit Hyperactivity Disorder. 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: 138
