PETAH TIKVA (dpa-AFX) - Teva Pharmaceutical Industries Limited (TEVA) presented new efficacy and safety data for ecopipam, an investigational, first-in-class selective dopamine D1 receptor antagonist being developed for pediatric patients with Tourette syndrome.
A pooled post hoc analysis found that 69.8% of 292 patients experienced a clinically meaningful reduction in tic severity within eight weeks of starting treatment.
An interim analysis of an ongoing open-label extension study showed a 45.6% mean reduction in tic severity scores through 18 months, with no new safety signals observed. The analysis included 118 participants with a median treatment exposure of 14.9 months.
The clinical program includes a Phase 2b randomized, double-blind, placebo-controlled study and a Phase 3 randomized withdrawal study evaluating the maintenance of efficacy in patients with Tourette syndrome.
Teva said additional analyses found that common co-occurring psychiatric conditions did not negatively affect ecopipam's efficacy or safety. The FDA has granted Priority Review and Orphan Drug designation for ecopipam in pediatric Tourette syndrome.
On Thursday, TEVA closed trade at $39.31, down 0.73%.
In premarket trading, shares are down 0.51% at $39.13.
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