Vanda Pharmaceuticals has put its social anxiety programme on hold after VQW-765, an on demand treatment for acute anxiety, failed its phase 3 trial. The study randomised 546 adults with social anxiety disorder to a single oral dose of the drug or placebo before a standardised public speaking stress test.
The primary endpoint measured distress during the test’s performance phase in female participants, the population in which a phase 2 subgroup analysis had favoured the drug. It was not close: women on VQW-765 scored 65.6 on the 100 point distress scale against 66.0 on placebo, a difference of minus 0.4 points with a p value of 0.8899. The key secondary endpoint in the full population also failed, at 64.7 versus 63.8, and analysts at Oppenheimer called the result a clean miss rather than a near miss. Vanda said the drug was well tolerated.
VQW-765, a partial agonist of the alpha 7 nicotinic acetylcholine receptor, came to Vanda from Novartis in a 2014 settlement. The company said development is suspended pending analysis of the full dataset, which leaves its December 12, 2026 FDA target action date for Quimilza as the next dated catalyst on its calendar.