Vanda anxiety treatment get positive response in first test

 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today reported results in a Phase II clinical study of VQW-765, a novel small molecule alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist, in the treatment of acute performance anxiety in social situations, such as public speaking.

In clinical study VP-VQW-765-2201 (Study 2201), 230 volunteers with prior history of performance anxiety were randomized to receive a single dose of VQW-765 or placebo and were challenged with the standardized Trier Social Stress Test (TSST). The TSST creates an acute stress by requiring participants to make an interview-style presentation in front of a panel who provides no feedback or encouragement. Participants who received VQW-765 showed numerically lower stress levels compared to those who received placebo.

In Study 2201, the stress level was assessed by the Subjective Units of Distress Scale (SUDS), a self-rating scale of level of nervousness or distress ranging from 0 to 100 at multiple timepoints during the duration of the TSST. In particular, female participants (approximately 70% of the total participants) reported a larger magnitude and statistically significant response to VQW-765. A higher stress reaction in females (as well as higher prevalence of performance anxiety) as compared to male participants is consistent with prior reports in this particular test of acute performance anxiety.1 A significant relationship was also seen between exposure to VQW-765 (amount of drug measured in blood) and the clinical response.

This is the first time that an alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist has shown efficacy in a clinical study of performance anxiety. The observed significant relationship between exposure and clinical outcome further supports the hypothesis that VQW-765 could be effective in treating performance anxiety and creates a valuable roadmap to future confirmatory studies. Clinical data gathered indicates an adverse event profile similar to placebo and there were no observed negative cognitive effects reported by any participant in Study 2201. If the results of the current study are confirmed, VQW-765 could be the first drug in the class of nicotinic receptor agonists approved to treat performance anxiety.

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