TEL AVIV, Israel I July 14, 2014 I Alcobra Ltd. (ADHD), an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced today that recruitment of patients has been completed in the Company’s Phase III clinical trial of Metadoxine Extended Release (MDX) in adult ADHD patients.
“I would like to thank all the patients who participated in the trial, as well as the professional work by our investigators who quickly and rigorously enrolled patients in less than four months,” said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. “We look forward to all patients completing the study protocol, and reporting the topline results later this quarter.”
The study is a 300-patient, randomized, placebo-controlled trial conducted at 18 sites in the United States and 2 in Israel. Patients were 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 include the computerized TOVA (Test of Variables of Attention), which was also used in the previous Phase 2 studies, as well as safety assessments and additional exploratory endpoints.
“We are pleased we have reached this important milestone in the execution of the trial,” said Dr. Richard Weisler, Principal Investigator of the study, adjunct professor of psychiatry at the University of North Carolina School of Medicine and adjunct associate professor of psychiatry at Duke University Medical Center. “There remain substantially unmet needs in the management of adult ADHD and this trial, when completed, will provide important clinical information to the medical community.”
As previously announced, Alcobra will host an Investor Forum on Tuesday, July 15, 2014 from 8am-9:30am Eastern Time in New York City. Management will provide an update on the ongoing development program for MDX. Dr. Craig Surman, MD, an expert in the management of adult ADHD will offer insights into the diagnosis and management of adult ADHD, and current therapeutic options and unmet medical needs in ADHD. Alcobra’s executive management team will provide an evidence-based overview of the commercial potential for its lead product, Metadoxine Extended Release (MDX), in ADHD based on recently completed primary and secondary research and analysis.
The presentations, followed by a question-and-answer session, will be webcast live beginning at 8am Eastern Time. The webcast and accompanying presentation materials will be accessible live and archived on the Investor Relations section of Alcobra’s website at www.alcobra-pharma.com.
About Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity Disorder (ADHD) is a common and impairing neuropsychiatric condition. Once believed to only affect children, ADHD is now known to persist into adolescence and adulthood in a sizeable number of cases. Key symptoms of ADHD include inattention, hyperactivity and impulsivity.
According to the Centers for Disease Control, about 9% of children in the U.S. meet criteria for ADHD with similar numbers reported in other countries. Although boys are more commonly diagnosed, ADHD is also common in girls who often go undiagnosed. Approximately 4-5% of adults worldwide are affected with ADHD, yet most adults with ADHD remain undiagnosed and untreated. There is no known cause of ADHD, however studies suggest that genetics may play a role.
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: 145
TEL AVIV, Israel I July 14, 2014 I Alcobra Ltd. (ADHD), an emerging pharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced today that recruitment of patients has been completed in the Company’s Phase III clinical trial of Metadoxine Extended Release (MDX) in adult ADHD patients.
“I would like to thank all the patients who participated in the trial, as well as the professional work by our investigators who quickly and rigorously enrolled patients in less than four months,” said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. “We look forward to all patients completing the study protocol, and reporting the topline results later this quarter.”
The study is a 300-patient, randomized, placebo-controlled trial conducted at 18 sites in the United States and 2 in Israel. Patients were 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 include the computerized TOVA (Test of Variables of Attention), which was also used in the previous Phase 2 studies, as well as safety assessments and additional exploratory endpoints.
“We are pleased we have reached this important milestone in the execution of the trial,” said Dr. Richard Weisler, Principal Investigator of the study, adjunct professor of psychiatry at the University of North Carolina School of Medicine and adjunct associate professor of psychiatry at Duke University Medical Center. “There remain substantially unmet needs in the management of adult ADHD and this trial, when completed, will provide important clinical information to the medical community.”
As previously announced, Alcobra will host an Investor Forum on Tuesday, July 15, 2014 from 8am-9:30am Eastern Time in New York City. Management will provide an update on the ongoing development program for MDX. Dr. Craig Surman, MD, an expert in the management of adult ADHD will offer insights into the diagnosis and management of adult ADHD, and current therapeutic options and unmet medical needs in ADHD. Alcobra’s executive management team will provide an evidence-based overview of the commercial potential for its lead product, Metadoxine Extended Release (MDX), in ADHD based on recently completed primary and secondary research and analysis.
The presentations, followed by a question-and-answer session, will be webcast live beginning at 8am Eastern Time. The webcast and accompanying presentation materials will be accessible live and archived on the Investor Relations section of Alcobra’s website at www.alcobra-pharma.com.
About Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity Disorder (ADHD) is a common and impairing neuropsychiatric condition. Once believed to only affect children, ADHD is now known to persist into adolescence and adulthood in a sizeable number of cases. Key symptoms of ADHD include inattention, hyperactivity and impulsivity.
According to the Centers for Disease Control, about 9% of children in the U.S. meet criteria for ADHD with similar numbers reported in other countries. Although boys are more commonly diagnosed, ADHD is also common in girls who often go undiagnosed. Approximately 4-5% of adults worldwide are affected with ADHD, yet most adults with ADHD remain undiagnosed and untreated. There is no known cause of ADHD, however studies suggest that genetics may play a role.
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: 145
