Alcobra Announces Completion Of All Patient Visits In Phase 3 Clinical Trial Of MDX In Adult ADHD
TEL AVIV, Israel, Sept. 19, 2014 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq: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 all scheduled follow-up visits have been completed for patients enrolled in the company's Phase III clinical trial of Metadoxine Extended Release (MDX) in adult ADHD patients.
"Completion of this Phase III clinical trial is a major milestone in the development of MDX, as we are one step closer to a potential new treatment alternative for Adult ADHD," said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. "We currently anticipate completing data verification in this multi-center trial, database lock and topline statistical analysis in approximately two weeks. We look forward to unblinding the data and announcing the results."
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 followed by a 2-week safety follow-up and preceded by a 2-week screening period. The primary endpoint measure is the Conners' Adult ADHD Rating Scale (CAARS-INV), a widely accepted clinical measure of the presence and severity of ADHD symptoms, and the same endpoint utilized in the company's successful Phase IIb study. Secondary endpoints include the computerized TOVA (Test of Variables of Attention), which was also used in the previous Phase II studies, as well as safety assessments and additional exploratory endpoints.
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 (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 has also begun separate Phase IIb trials in pediatric ADHD and in adolescents and adults with Fragile X Syndrome. Alcobra was founded in 2008 and is traded on the NASDAQ under "ADHD." For more information please visit the Company's website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based on Alcobra's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Alcobra could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding expected timing of providing topline results of the company's Phase III clinical trial. In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not suggest different conclusions or that historic results referred to in this press release would be interpreted differently in light of additional research and clinical and preclinical trials results. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in Alcobra Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2013 filed with the Securities and Exchange Commission (SEC) and in subsequent filings with the SEC. Except as otherwise required by law, Alcobra disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.
CONTACT: U.S. Investor Contacts LifeSci Advisors, LLC Michael Rice 646-597-6979 mrice@lifesciadvisors.com Media Inquiries Sam Brown, Inc. Mike Beyer 773-463-4211 mikebeyer@sambrown.com Israel Investor Contact: Alcobra Investor Relations Debbie Kaye +972-72 2204661 debbie@alcobra-pharma.com 