Alcobra Ltd fka ADHD

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Alcobra Announces Topline Results From Phase III Study of MDX in Adult ADHD

Company to hold a conference call Monday, October 6, 2014 at 8:30am EDT

TEL AVIV, Israel, Oct. 6, 2014 (GLOBE NEWSWIRE) -- 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, today announced topline results from a Phase III study of Metadoxine Extended Release (MDX) in adults with ADHD. In a modified Intent To Treat (mITT) population (n=293), MDX demonstrated a statistically significant improvement in ADHD symptoms compared to placebo as measured by the Conner's Adult ADHD Rating Scale (CAARS-INV) (p<0.03). The mITT population was derived by a post hoc exclusion of four subjects with extreme placebo responses (The ITT analysis before exclusion yielded a positive trend, p=0.15; n=297).

"This is a key milestone for Alcobra," said Dr. Yaron Daniely, Alcobra's President and Chief Executive Officer. "We are encouraged by these findings, as they build upon our Phase II studies showing that MDX significantly improved symptoms of ADHD without many of the safety and tolerability issues commonly associated with currently available ADHD medications. We look forward to completing the full analysis on the secondary endpoints in the study and reporting the complete data set in the near future."

The 300-patient, randomized, placebo-controlled study was conducted at 18 sites in the United States and 2 in Israel. Approximately 70 percent of patients were enrolled in the U.S., and patients were nearly evenly split between men and women. Patients were randomized to receive either 1400 mg of MDX or placebo over 6 weeks. The primary endpoint was the CAARS-INV, a widely accepted clinical measure of the presence and severity of ADHD symptoms, which has been utilized in registration studies for other approved ADHD drugs.

In the mITT analysis, there was a mean change on the CAARS-INV from baseline to the final visit of 11.6 in the MDX treated group as compared with a mean change of 8.7 in the placebo treated group (p<0.03). MDX also showed a statistically significant impact on the inattention subscale of the CAARS-INV (p<0.05). Patients with both predominately inattentive (PI) ADHD and combined type (CT) ADHD subtypes appeared to benefit similarly in this trial.

"We conducted the mITT analysis after observing the disproportional effect of a few extremely large placebo responses which were inconsistent with what has been reported in previous ADHD trials of MDX or other agents," said Dr. Jonathan Rubin, Alcobra's Chief Medical Officer. "We plan to take the complete findings of this and other MDX studies to the FDA to determine the next steps on the path to potential regulatory approval for MDX."

MDX was well tolerated during the trial. The number of patients reporting adverse events was similar between the MDX and placebo groups with no drug-related serious adverse events reported. The most common adverse events seen in the study were headache (15.1% in MDX group vs. 12.3% in placebo group), nausea (8.6% vs. 6.2%), and fatigue (7.2% vs. 8.2%).

Detailed results of the study will be made available at various scientific and medical conferences in the coming weeks, as well as in peer-reviewed publications. Additional advanced clinical studies of MDX in adolescents with ADHD, as well as in adolescents and adults with Fragile X Syndrome are currently actively enrolling patients. These studies are expected to be completed by the end of 2014.

Conference Call

Monday, October 6 2014, @ 8:30am Eastern Time/5:30am Pacific Time
Domestic: 855-469-0611
International: 484-756-4341
Conference ID: 15517950
Webcast: http://www.media-server.com/m/p/bsr2eo4r