Washington, DC-based Vanda Pharmaceuticals (Nasdaq: VNDA) reported that its Phase III trial of VQW-765, an α7-nicotinic acetylcholine receptor partial agonist, failed to meet its primary endpoint when being tested as an on-demand treatment of acute anxiety in adults with social anxiety disorder (SAD). The program is now on hold pending further analysis.
The Phase III trial VP-VQW-765-3201 randomized 546 adults with social anxiety disorder to a single oral dose of VQW-765 or placebo at approximately 30 US sites. Its primary endpoint assessed distress during the performance phase of the Trier Social Stress Test in female participants, using the Subjective Units of Distress Scale (SUDS).
VQW-765 showed no statistically significant benefit over placebo on the primary endpoint (least squares mean difference −0.4; 95% CI −5.32 to 4.62; p=0.8899). The key secondary endpoint assessing the same measure in the full intention-to-treat population also failed (least squares mean difference 0.9; 95% CI −3.00 to 4.73; p=0.6605). Vanda described the drug as well tolerated but did not provide detailed adverse-event rates in the announcement.
The findings failed to confirm a signal seen in an earlier Phase II trial involving 230 adults with a history of public-speaking anxiety. That study did not demonstrate a statistically significant benefit over placebo in the overall population during the stress test’s performance phase (p=0.1443), although a female subgroup analysis favored VQW-765 (p=0.034).