UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of: July 2014
ALCOBRA LTD.
(Translation of registrant's name into English)
Amot Investment Building
2 Weizman St. 9th Floor
Tel Aviv 6423902 Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1):_____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7):_____
Indicate by check mark, whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ¨ No x
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): ___
Attached hereto and incorporated by reference herein is the registrant's press release issued on July 14, 2014.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
Alcobra Ltd.
| ||
| Name: Dr. Yaron Daniely | ||
| Chief Executive Officer and President |
Date: July 14, 2014
| U.S. Investor Contacts | Media Inquiries | Israel Investor Contact: |
| LifeSci Advisors, LLC | Sam Brown, Inc. | Alcobra Investor Relations |
| Michael Rice | Mike Beyer | Debbie Kaye |
| 646-597-6979 | 773-463-4211 | +972-72 2204661 |
| mrice@lifesciadvisors.com | mikebeyer@sambrown.com | debbie@alcobra-pharma.com |
Alcobra Completes Patient Recruitment in Phase III Clinical Trial of MDX in Adult ADHD
Tel Aviv, Israel – July 14, 2014 – Alcobra Ltd. (NasdaqGM: 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.
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 regarding expected timing of completion of the Phase 3 clinical trial reported above and reporting topline results, the design of the Phase 3 clinical trial in question and importance of the results from such trial, if reported, to the medical community. 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 filed with the Securities and Exchange Commission ("SEC") on March 28, 2014, 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.
# # #