Alcobra (ADHD) reported today that its Phase 2 clinical trial of MDX (Metadoxine Extended Release) for the treatment of Fragile X Syndrome (FXS) did not meet its primary endpoint. 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. In the study, MDX was generally well tolerated and no safety concerns were identified, Alcobra said.
There are no approved medications to treat FXS. MDX has received an Orphan Drug designation from the US 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," said 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."
Alcobra's share price is currently down 16.75%.
Published by Globes [online], Israel business news - www.globes-online.com - on June 24, 2015
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