- MDX produced statistically significant improvement (p < 0.01) on the primary endpoint compared to placebo
- MDX was superior to placebo after a single dose while demonstrating a safety profile comparable to placebo
- Second placebo-controlled Phase II study in adults with ADHD to demonstrate the efficacy and tolerability of MDX
NEW YORK, May 5, 2014 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical 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 the presentation of data from a successful Phase IIb study of its proprietary drug candidate MDX (Metadoxine Extended Release) in adults with Predominantly Inattentive ADHD (PI-ADHD) at the 167th Annual Meeting of the American Psychiatric Association (APA).1
"Results from this study showed that MDX provided significant benefit for adults with PI-ADHD after one dose and was as well tolerated as placebo, suggesting that it could eventually offer an attractive non-scheduled treatment option," said Iris Manor, M.D., senior lecturer and director of the ADHD unit at Geha Mental Health Center. "Evidence of a preferential effect of MDX in this patient population further distinguishes it from conventional stimulant and non-stimulant medications, and we are very excited to share these data with the ADHD treatment community through this important scientific forum."
This Phase IIb randomized, double-blind, placebo-controlled, cross-over, single center study enrolled 36 adult patients (18 to 55 years old) with diagnosed PI-ADHD. Eligible subjects were randomly assigned in a 1:1:1 ratio to one of three treatment sequences that varied the order of investigational product administration. In each sequence, subjects received a single dose, approximately one week apart, of MDX 1400 mg, MDX 700 mg, and placebo. The primary endpoint of the study was the mean change from baseline of the Test of Variable of Attention (TOVA®) ADHD Score. The TOVA is a computerized continuous performance test (CPT) that provides information about an individual's sustained attention, speed and consistency of responding, and behavioral self-regulation.
As previously announced, the intent-to-treat analysis of the primary endpoint demonstrated a statistically significant change from baseline for a single dose of MDX 1400 mg compared with placebo on the TOVA ADHD Score (mean change 2.0, SD 4.2, p = 0.009). The study also demonstrated a statistically significant change from baseline for MDX 1400 mg compared to placebo on the TOVA sub-score of response time variability (mean change 7.9, SD 19.2, p = 0.022), a sub-score correlated with attention and cognition. In addition, the percentage of responders following a single dose of MDX 1400 mg was significantly greater compared with placebo. There were no significant differences observed between the MDX 700 mg dose and placebo in the primary or secondary efficacy endpoints. Between the two doses of MDX, the 1400 mg dose demonstrated significantly greater improvements (p < .05) than the 700 mg dose on most endpoints.
There were no serious adverse events or any meaningful differences in adverse events profiles between the drug and placebo groups. The most common treatment emergent adverse events (TEAEs) during the active treatment period were fatigue and headache. All adverse events were mild except for three reports of moderate headache. No clinically significant abnormalities in laboratory values, vital sign measurements, ECG parameters, or findings at clinical examination were observed.
Based on these results and the successful outcome of a prior Phase II placebo-controlled study of MDX, Alcobra is moving forward with a Phase III trial in adults with ADHD. The study is expected to be completed in the second half of 2014.
The Predominantly Inattentive subtype of Attention Deficit Hyperactivity Disorder (PI-ADHD) is characterized by symptoms of inattentiveness. Individuals tend to be easily distracted and forgetful of details of daily routines and typically have problems organizing or finishing tasks, paying attention to details, and/or following instructions or conversations. The PI-ADHD subtype differs from the more commonly recognized combined subtype of ADHD in that symptoms of hyperactivity and impulsivity may be absent or minimal. It is estimated that approximately 30 to 40% of people with ADHD have the Predominantly Inattentive subtype.
About Alcobra Ltd.
Alcobra Ltd. is an emerging biopharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MDX (Metadoxine Extended Release (MG01CI)), to treat cognitive dysfunctions including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome. MDX has completed Phase II studies to treat Attention Deficit Hyperactivity Disorder. 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 our plan to initiate a Phase III clinical trial in adults with ADHD and the timing thereof, if such trial is commenced at all. 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.
1. APA Poster #NR6-21. Rubin J, Adler LA, Daniely Y, Manor I, et al. The effects of ADHD pharmacologic treatments on adult ADHD subtypes with an examination of the effects of MG01CI on adult subjects with PI-ADHD.
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