NEW YORK, NY -- (Marketwired) -- 09/23/13 --
LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of Alcobra Ltd. (NASDAQ: ADHD), a clinical stage biopharmaceutical company developing MG01CI, an oral, extended-release, non-stimulant treatment for attention deficit hyperactivity disorder (ADHD). Alcobra completed a successful Phase IIb trial of MG01CI (Metadoxine extended release) in adult ADHD patients that demonstrated strong efficacy, especially in patients with predominantly inattentive ADHD (PI-ADHD). Phase III trials in the US are expected in 2013, with a potential initial approval in 2015, followed by label expansion into the pediatric population and other indications. Alcobra also recently announced pre-clinical data demonstrating the potential of MG01CI to treat Fragile X Syndrome.
"Alcobra's MG01CI, a potential non-stimulant treatment for ADHD, addresses a large unmet medical need for ADHD patients," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "A safe and effective alternative to current therapies with a differentiated mechanism of action such as MG01CI has the potential to capture a large market share and become a blockbuster treatment for ADHD."
The Phase IIb trial of MG01CI in adult ADHD patients was a double blind, placebo-controlled trial that enrolled 120 patients who were randomized to receive either 1,400 mg of MG01CI daily or corresponding placebo for 6 weeks. The primary endpoint was a difference between the arms on the Investigator Rated Conners' Adult ADHD Rating Scales (CAARS-INV). Secondary measurements included the Test of Variables of Attention (TOVA), Adult ADHD Quality of Life (AAQoL), and the Clinical Global Impression Scale Improvement (CGI-I) score. Patients treated with MG01CI in the trial experienced a statistically significant improvement in the primary endpoint of CAARS-INV total ADHD symptoms score (p=0.02). MG01CI was statistically superior to placebo on improvements in TOVA score (p=0.02) and AAQoL score (p=0.01). The treatment effect was observed as early as 2 weeks, indicating a rapid onset of action for MG01CI, which is in contrast to atomoxetine, which can take six to ten weeks to begin working. The trial also revealed that MG01CI was well tolerated.
One of the key observations from the Phase IIb trial was stronger efficacy in patients with PI-ADHD. As a result, Alcobra is running a small Phase II trial to determine the best dose of MG01CI for these patients. The Company is also in discussions with the FDA for a US-based Phase III clinical program in adult ADHD patients. Following a potential approval of MG01CI for adult ADHD patients, the Company intends to seek label expansion into the pediatric population. MG01CI is also a potential treatment for Fragile X Syndrome.
In a 40 page Initiation Report by LifeSci Advisors, we explain the development path going forward for MG01CI as a treatment for adult ADHD patients, with potential expansion into the pediatric population. Alcobra is also planning to develop MG01CI as a treatment for Fragile X Syndrome. The report discusses the competitive advantages of MG01CI over ADHD treatments and how these position the drug within the marketplace. We discuss the landscape for ADHD treatment, including mechanisms of action, side effects, and historical sales. The report details the mechanism of action, clinical history, intellectual property portfolio, and future development plans for MG01CI.