AtaiBeckley Inc. (ATAI) has announced positive topline results from its exploratory, double blind, placebo-controlled, first-in-patient phase 2a study of EMP 01 in adults with Social Anxiety Disorder.
Social Anxiety Disorder (SAD) is a condition where a person feels intense fear or nervousness in social situations. They often worry about being judged, embarrassed, or criticized, which can make everyday interactions very stressful. Globally, an estimated 400-800 million people are affected by this disorder.
While several treatments are approved for SAD, no novel therapies have been introduced in more than two decades. The most recent FDA approvals date back to Effexor in 2003, Zoloft in 2002, and Paxil in 1999.
The primary endpoint of the phase 2a study of EMP 01 was safety and tolerability through Day 43, and the secondary endpoint was the change in social anxiety symptoms from baseline to Day 43, using the Liebowitz Social Anxiety Scale (LSAS).
According to the results announced today, the trial met its primary safety objective and generated encouraging secondary and exploratory efficacy signals. The company expects to share more detailed results at upcoming scientific meetings that will help guide the next steps in development.
ATAI closed Wednesday's trading at $4.34, down 0.69%. In premarket trading on Thursday, the stock is up over 5% at $4.57.
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