- A late-stage clinical failure is a blow to any company, particularly if it has just one candidate. That scenario played out on Tuesday for Alcobra, an Israeli biopharma focused on cognitive disorder treatments.
- In a Jan. 17 statement, the company revealed its drug, metadoxine extended release (MDX), did not significantly outperform placebo in treating attention deficit hyperactivity disorder (ADHD) as judged by the Conners' Adult ADHD Rating Scales — a tool used to evaluate the severity of the disease's symptoms.
- The trial failure is a crushing blow for Alcobra, which has had continued trouble with MDX over the last couple years. The company's stock traded at 94 cents per share at market close Tuesday, down more than 50% from the day prior.
MDX's troubled history began in mid-2015. Alcobra was investigating the drug as treatment for fragile X syndrome, but it failed in Phase 2 that year.
And the outlook for the drug worsened this past September when the Food and Drug Administration gave verbal warning of a full clinical hold for a Phase 3 study, known as MEASURE, testing for the ADHD indication. The agency cited "adverse neurological findings" from preclinical testing as the reason for the hold.
"In the coming weeks, the Company intends to review the full data set from MEASURE," Alcobra's CEO Yaron Daniely said in the Jan. 17 statement. "Consequently, we will evaluate our options and communicate our strategic plan to investors."
Year-to-date, the company's stock has plummeted more than 86%. It was founded in 2008 and went public in 2013. According to its most recent annual filing with the Securities and Exchange Commission, it spent about $48 million on research and development since 2011.
The news is also bad for Alcobra given the success other ADHD drugmakers have had as of late. Supernus revealed positive Phase 2b data for its candidate, SPN-812 (viloxazine), in October, and plans to push it into late-stage testing this year. And in June, Shire announced its ADHD medication SHP465 trumped placebo in a Phase 3 trial.
The industry can expect a continued focus on ADHD given the disease's large patient population. Data compiled by the Centers for Disease Control estimates as many as 11% of children aged 4 to 17 have the disease. What's more, a recent report from Persistence Market Research projected the global market for ADHD will grow at a compounded annual growth rate of 6.2% from 2015 to 2024, reaching $25 billion in value by the out year.