Alcobra Reports Adult ADHD Drug Failed Late-Stage Study

Alcobra, a pharmaceutical company based in Israel, announced on Tuesday that its experimental drug for treating attention deficit hyperactivity disorder (ADHD) missed its primary endpoint in a second Phase 3 clinical trial.

The drug is called Metadoxine Extended Release (MDX), which was being tested as therapy for adults with ADHD in a study featuring 283 patients.

Results from the trial had failed to produce a statistically significant benefit from placebo in helping patients cope with the symptoms forcing the company to end the ADHD development program.

“We are exceedingly disappointed with these top-line results. In the coming weeks, the company intends to review the full data set from MEASURE. Consequently, we will evaluate our options and communicate our strategic plan to investors,” said Alcobra’s President & CEO Yaron Daniely, Ph.D., in a statement.

MDX has traversed a difficult path during the research and development process.

The Food and Drug Administration placed a full clinical hold on the drug in September 2016 after reviewing preclinical data that indicated “adverse neurological findings,” showing potentially damaging effects on peripheral nerve function in animal studies,according to FierceBiotech.

The full clinical hold became partial last month, but the primary concern with this therapy was the efficacy of it instead of safety concerns during human trials. MDX was well tolerated in this recent evaluation as well.

Essentially, the hope was that MDX could give Alcobra an advantage in the growing ADHD treatment market. A report from research and consulting firm GlobalData predicts this market could be a lucrative opportunity for drugmakers who create new effective treatment options.

Alcobra may continue developing MDX for other treatment options such as Fragile X syndrome, which is a rare genetic condition that can cause intellectual disability.

The company’s share price is currently down almost 50 percent in mid-day trading.