--Last patient visit scheduled for November 26, 2013
--Data expected to be announced during the week of December 16, 2013
TEL AVIV, Israel, Nov. 5, 2013 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate, MG01CI (Metadoxine extended-release), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, announced today that it has successfully enrolled the 36th and final patient in a placebo-controlled Phase II clinical study designed to compare the efficacy of varied dosage levels of MG01CI to treat and improve cognitive dysfunctions in adult subjects with Predominantly Inattentive Attention Deficit/Hyperactivity Disorder (PI-ADHD). The last patient visit is scheduled for November 26, 2013 and the data is expected to be announced during the week of December 16, 2013.
"This study is an important extension of our efforts to better understand the clinical benefits of MG01CI beyond treating patients exhibiting core ADHD clinical symptoms," commented Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra Ltd. "In addition to ADHD, our goal is to take advantage of the favorable safety and efficacy profile of MG01CI to potentially treat other major cognitive disorders such as Fragile X Syndrome."
The data from the study is expected to confirm and consolidate previous observations about MG01CI, including: the significant effect size seen in PI-ADHD patients; the benefits on executive functions (beyond core deficits of ADHD) such as spatial and working memory, visual information processing, reaction time and inhibitory control; and the rapid onset of the drug (as compared to other non-stimulants ADHD drugs that take several weeks).
The study is evaluating 700mg and 1,400mg doses, which were found to be most effective in previous Alcobra studies.
The study is registered on ClinicalTrials.gov, number NCT01685281.
About Alcobra Ltd.
Alcobra Ltd. is an emerging biopharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MG01CI, to treat cognitive dysfunctions including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome. MG01CI has completed Phase II studies to treat ADHD. 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.
Forward Looking Statements
This press release may contain 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 that imply that MG01CI may be helpful to treat cognitive dysfunctions such as ADHD and Fragile X or statements regarding the completion of the PI-ADHD clinical trials, timing of announcing data and expected results from such trial as well as implications of such results on the process of developing our drug candidate. In addition, historic results of scientific research do not guarantee that the conclusions of future research would not suggest different conclusions or that historic results referred to in this press release would be interpreted differently in light of additional research. 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 registration statement on Form F-1A filed with the Securities and Exchange Commission ("SEC") on October 22, 2013, 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.