Alcobra Ltd (NASDAQ: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 (FXS), reported that the company’s Phase 2 clinical trial of MDX (Metadoxine Extended Release) for the treatment of FXS did not meet the primary endpoint of change from baseline to week 6 of the inattentive subscale of the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS-IV). The difference between treatment groups was not statistically significant. However, MDX did achieve statistical significance, in the Intent-to-Treat (ITT) population, on two secondary endpoints, including the Vineland Adaptive Behavior Scale (VABS) Daily Living Skills Domain (p=0.044), and the computerized cognitive Test of Attentional Performance for Children (KiTAP) Distractibility subscale (p=0.017). In the study, MDX was generally well tolerated and no safety concerns were identified.
“The combination of significant improvements in adaptive behavior and cognition, obtained both by caregiver interview, and direct objective patient assessment, suggests a meaningful finding,” commented Elizabeth Berry Kravis, MD, PhD, Professor of Pediatrics, Neurological Sciences, and Biochemistry at Rush University Medical Center, and the Principal Investigator of the study. “Previous placebo-controlled trials in adolescent and adult patients with Fragile X have failed to demonstrate such an effect even after a longer treatment duration.”
There are no approved medications to treat FXS. MDX has received an Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of FXS. Alcobra plans to discuss these trial results with the FDA before finalizing the design of the next study of MDX in FXS.
“We are encouraged by the positive findings on two clinically relevant secondary measures, most notably daily functional behavior such as managing time and money, and completing domestic chores, as well as the further evidence of the pro-cognitive activity of MDX” stated Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. “FXS is a difficult disease to treat and study, as demonstrated by the lack of approved treatments. Our findings suggest a clinically meaningful advance for patients and caregivers affected by FXS and we plan to meet with the FDA to determine next steps in advancing our research,” added Dr. Daniely.
The purpose of the randomized, double-blind, placebo-controlled, multi-center Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT02126995) was to assess the efficacy and safety of MDX compared to placebo in 62 adolescent and adult patients with FXS, a rare neurogenetic condition and the leading known genetic cause of autism. Efficacy measures included both behavioral and cognitive scales. (Original Source)
Shares of Alcobra Ltd closed yesterday at $8.39 . ADHD has a 1-year high of $22.19 and a 1-year low of $3.12. The stock’s 50-day moving average is $7.06 and its 200-day moving average is $6.07.
On the ratings front, Roth Capital analyst Debjit Chattopadhyay reiterated a Buy rating on ADHD, with a price target of $10, in a report issued on May 31. The current price target represents a potential upside of 19.2% from where the stock is currently trading.
According to TipRanks.com, Chattopadhyay has a total average return of 36.5%, a 72.6% success rate, and is ranked #9 out of 3640 analysts.
Alcobra Ltd is a biopharmaceutical company which engaged in the development and commercialization of its proprietary oral drug candidate, MDX, to treat ADHD and other cognitive dysfunctions including Fragile X Syndrome.