Teva and partner Alcobra have reported positive new data on a candidate drug for attention-deficit hyperactivity disorder and say they plan to advance it to a full Phase III trials programme next year.
The success of the Phase II trial of MG01CI - an extended release formulation of Metadoxine (pyridoxol L-2-pyrrolidone-5-carboxylate) - has prompted Teva to make an undisclosed equity investment in Alcobra and negotiate the right to acquire the company outright should MG01CI reach the market.
Metadoxine has been used as a treatment for acute alcohol intoxication and treatment of alcohol withdrawal syndrome for more than 30 years.
In the 120-patient study, MG01CI-treated individuals showed significant improvements on a battery of tests used to measure ADHD symptoms, and the trial met both primary and secondary efficacy endpoints. All told, 44% of the MC01CI patients showed improvement of at least 40% on rating scales, compared to 25% of those on placebo.
No differences were recorded in adverse event rates between treated patients and those on placebo.
"These results confirm previous clinical experience indicating MG01CI may have a quick onset of activity with few side effects, distinguishing it from other non-stimulant ADHD treatments," said Dr. Yaron Daniely, Alcobra's chief executive.
That profile could make MG01CI a strong entrant into the $5 billion market for ADHD drugs, which has continued to show fairly strong growth in the last few quarters despite speculation that it is due a major slowdown. At the end of last year for example Decision Resources suggested that market would contract to around $4.1 billion in 2015.
Additional Phase II study results for MG01CI in ADHD are planned to be presented at international scientific meetings later this year.
The news provided a boost for Teva's branded drug division yesterday, coming just after the start of a US court case to defend top-selling multiple sclerosis drug Copaxone (glatiramer acetate) from generic competition.