Clinical Trials

* On October 6, 2014, Alcobra, 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 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). 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. 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.

* On September 19, 2014, Alcobra announced 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.

* On July 14, 2014, Alcobra announced that recruitment of patients has been completed in the Company's Phase III clinical trial of Metadoxine Extended Release (MDX) in adult ADHD patients.

* On March 18, 2014, Alcobra has announced that, following the recent FDA acceptance of the Company\'s IND for MDX, the first patient has been enrolled in a Phase 3 clinical trial of MDX in the treatment of Adults with ADHD.