MAC Clinical Research is pleased to announce positive topline results from AtaiBeckley’s exploratory Phase 2a clinical trial evaluating an investigational therapy in Social Anxiety Disorder (SAD), conducted across MAC’s site network.
The exploratory Phase 2a study of EMP-01 (oral R-MDMA) in Social Anxiety Disorder (SAD) met its primary objective on safety and tolerability, demonstrating a generally favourable and manageable safety and tolerability profile. No serious adverse events and no treatment-emergent suicidal behaviour or intent were observed. Most adverse events were mild or moderate and resolved without intervention. Importantly, the secondary and exploratory efficacy endpoints of change in social anxiety symptoms from baseline to Day 43, using the Liebowitz Social Anxiety Scale (LSAS) and changes on the Clinician-Rated Global Impression-Improvement (CGI-I) scale, showed encouraging signals.
Dr. David Feifel, Professor Emeritus of Psychiatry at the University of California, San Diego, Founder and President of the Kadima Neuropsychiatry Institute, and consultant to AtaiBeckley, noted that “LSAS improvements became apparent after dosing was completed and the drug was no longer present, suggesting a sustained biological therapeutic effect”.
Dr Shoona Vincent, Vice President of Clinical Science at MAC Clinical Research, commented:
“Seeing positive topline results in an exploratory Phase 2a study like this is very encouraging. It’s particularly notable that we’re observing early signs of improvement after just two administrations in a population with significant unmet need. While these are still early data, they support continued research into this investigational therapy as a potential new approach for Social Anxiety Disorder.”
Further details: https://ir.ataibeckley.com/news-releases/news-release-details/ataibeckley-announces-positive-topline-results-exploratory-phase
