Vanda Pharmaceuticals Says Experimental Anxiety Treatment Misses Primary Endpoint

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) on Wednesday shared an update regarding its clinical development pipeline.

The company’s Phase 3 trial evaluating VQW-765, a small molecule alpha-7 nicotinic acetylcholine receptor partial agonist, failed to achieve its primary objective.

The trial tested the drug as an on-demand therapy for adults suffering from acute social anxiety, but results showed no significant benefit over a placebo.

Trial Design and Participant Details

Study 3201 randomly assigned 546 adult participants, ranging in age from 18 to 65.

Each participant had a current diagnosis of social anxiety disorder and exhibited elevated baseline anxiety scores on both the Liebowitz Social Anxiety Scale and the Public Speaking Anxiety Scale.

Medical staff administered a single oral dose of either VQW-765 or a placebo in an equal ratio.

Following the dosage, researchers challenged the participants with the standardized Trier Social Stress Test.

The specific evaluation induces acute stress by requiring subjects to first prepare and subsequently deliver an interview-style speech to a panel of judges who provide zero feedback or encouragement.

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Primary and Secondary Endpoints Missed

The trial’s primary endpoint focused entirely on the female participant population. Researchers measured the level of distress during the performance segment of the stress test using the Subjective Units of Distress Scale.

This scale requires participants to rate their personal nervousness from zero to 100. The data revealed that female subjects who consumed VQW-765 failed to demonstrate a statistically significant difference compared to the placebo group.

Additionally, the study missed its essential secondary endpoint. The drug did not sufficiently reduce subjective distress scores during the performance phase across the complete trial population involving both men and women.

Phase 2 Findings Unconfirmed

Vanda explicitly designed Study 3201 to verify the promising data generated during an earlier Phase 2 trial.

During that preceding study, subjects suffering from a history of performance anxiety reported numerically lower stress measurements after taking VQW-765 instead of a placebo.

Ultimately, the broader Phase 3 data could not replicate or confirm those initial findings.

VNDA Price Action: Vanda Pharmaceuticals shares were down 2.51% at $4.11 during premarket trading on Thursday. The stock is trading at a new 52-week low, according to Benzinga Pro data.

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