Israeli drug developer Alcobra Ltd reported their attention-deficit/hyperactivity disorder (ADHD) candidate failed a Phase III trial. Metadoxine extended release (MDX) missed primary endpoint and did not demonstrate a statistically significant difference from placebo in the change from baseline as measured using the Conners' Adult ADHD Rating Scales (CAARS).
Alcobra Is Evaluating Assets And Will Present Strategic Plans To Investors
MDX is Alcobra's only experimental drug to treat ADHD, Reuters reported. Chief Executive Dr. Yaron Daniely confirmed that the company is evaluating assets and will present its strategic direction to shareholders in the coming weeks.
"We are exceedingly disappointed with these top-line results. Daniely said. He also added that Alcobra will review the full data set from MEASURE. "Consequently, we will evaluate our options and communicate our strategic plan to investors." He also said that the company sincerely appreciates all the patients, investigators, and others who aided Alcobra in conducting the study.
The top-line data analysis was conducted on the Full Analysis Set, which includes all subjects which are randomized with at least one post-baseline efficacy assessment. Consistent with previously conducted studies, MDX was generally well tolerated, GlobalNewswire Reported.
MDX Was Not Able To Induce A Statistically Significant Benefit Over A Placebo
The company said that MDX was not able to induce a statistically significant benefit over a placebo in the 283-patient "MEASURE" trial. In addition to ADHD, Alcobra is developing MDX as a treatment for Fragile X syndrome - a genetic condition that causes developmental problems - and cognitive impairment.
Alcobra's announcement came just a week after FDA approved agreement to review data collected to date in the MEASURE study, and consider it in a future NDA submission of MDX for ADHD. Daniely said that they will continue to explore the promise of MDX in other conditions, possibly with a partner in Europe.
