×

Alcobra Enrolls First Patient in Comparative Study of Executive Function Benefits in Patients With PI-ADHD

TEL AVIV, Israel, Aug. 26, 2013 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug, MG01CI, to treat Attention Deficit/Hyperactivity Disorder (ADHD), announced today that it has enrolled its first patient in a placebo-controlled clinical study designed to compare the efficacy of varied dosage levels of MG01CI to treat and improve executive dysfunctions in adult patients with Predominantly Inattentive Attention Deficit/Hyperactivity Disorder (PI-ADHD). The clinical study will enroll up to 36 adult PI-ADHD patients and is expected to be completed in the fourth quarter of 2013.

"This study adds a new dimension to our clinical development of MG01CI for the treatment of ADHD and potentially other cognitive disorders as well. While this study will not impact the launch of our Phase III trial scheduled for later this year, we believe it will strengthen and broaden our understanding of the clinical benefits of MG01CI compared to existing non-stimulant medications," commented Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra Ltd. "We have expanded the cognitive tests being administered in this comparative study, which will offer us a greater understanding of the impact MG01CI is having on patients beyond treatment of core ADHD clinical symptoms."

Alcobra's previous Phase IIa and IIb studies utilized doses of MG01CI ranging from 700mg to 2,100mg for treating ADHD in adults. This study will evaluate 700mg and 1,400mg doses, which were found to be most effective in these previous 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, MG01CI, to treat Attention Deficit Hyperactivity Disorder (ADHD). MG01CI has completed Phase II studies to treat ADHD. The company was founded in 2008 and is headquartered in Tel Aviv, Israel.

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 commencement, timing of commencement and advancement of clinical trials, the possible future effect of the MG01CI product on the ADHD market and change in levels of expenses. 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-1 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: KCSA Strategic Communications Jeffrey Goldberger / Garth Russell +1 212.896.1249 / +1 212.896.1250 jgoldberger@kcsa.com / grussell@kcsa.com Israel Investor Contact: Investor Relations Ltd. Moran Meir-Beres +011972-3-5167620 moran@km-ir.co.ilSource:Alcobra Ltd.