Vanda Pharmaceuticals has placed its VQW-765 development program on hold after a Phase 3 trial failed to meet its primary and key secondary endpoints for on-demand treatment of acute anxiety in adults with social anxiety disorder.
The company will analyze the full dataset before determining the program’s future. Vanda said the drug was safe and well tolerated, consistent with earlier studies.
Study 3201 enrolled 546 adults aged 18 to 65 at approximately 30 U.S. sites. Participants were randomized equally to receive a single oral dose of VQW-765 or placebo before undergoing a standardized psychosocial stress test.
The Trier Social Stress Test required participants to prepare and deliver an interview-style presentation before a panel offering no feedback or encouragement.
The primary endpoint assessed distress during the presentation among female participants using the Subjective Units of Distress Scale. Scores range from zero to 100, with higher values indicating greater distress.
Female participants receiving VQW-765 recorded a mean score of 65.6, compared with 66.0 for placebo. The difference was not statistically significant, with a p-value of 0.8899.
In the full population, mean scores were 64.7 with VQW-765 and 63.8 with placebo. That difference was also not statistically significant, missing the key secondary endpoint.
The trial was intended to confirm an earlier Phase 2 study in which treated participants reported numerically lower stress levels. The Phase 3 results did not confirm those findings.
VQW-765 is an alpha 7 nicotinic acetylcholine receptor partial agonist licensed from Novartis. It was previously known as AQW-051 before Vanda’s development program.
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