A phase 3 study evaluating the efficacy of troriluzole as monotherapy for generalized anxiety disorder (GAD) did not meet its primary end point of significant change from baseline on the Hamilton Anxiety Rating Scale (HAM-A).
Troriluzole is a third-generation tripeptide prodrug conjugate of riluzole, a glutamate modulating agent. Patients (N=402) in the study were randomized to receive the investigational therapy or placebo twice daily for 8 weeks. The primary outcome measure was the change from baseline in the total score measured by HAMA-A, with a decreased score indicating a decrease in anxiety symptoms.
Results showed a mean change from baseline of -9.28 points (95% CI, -10.23 to -8.32) on the HAM-A total score in patients treated with troriluzole compared with -9.35 points (95% CI, -10.34 to -8.36) with placebo (P =.917).
“While these efficacy results were disappointing and do not support continued development of troriluzole as a monotherapy in GAD, we have multiple ongoing studies evaluating troriluzole in other disease indications and with different dosing paradigms,” said Vlad Coric, MD, Chief Executive Officer of Biohaven.
Troriluzole is currently being investigated for the treatment of spinocerebellar ataxia, Alzheimer disease, and obsessive compulsive disorder. “We eagerly await topline data from our adjunctive therapy trial in OCD, and our symptomatic treatment trials in Alzheimer disease and spinocerebellar ataxia,” added Coric.
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