MAC Clinical Research is pleased to announce the successful dosing of the first participant in a Phase 2 clinical study investigating a psychedelic investigational compound being developed for the treatment of Social Anxiety Disorder (SAD).
The compound being studied is an oral formulation of R-3,4-methylenedioxy-methamphetamine (R-MDMA), which is being explored as a potential short-term therapeutic intervention. The phase 2 study will determine the safety and tolerability of repeated oral doses of the compound and assess exploratory efficacy compared to placebo.
This multi-site study is being conducted across seven MAC sites in the UK and will enrol approximately 60 adults with SAD. Participants will receive two oral doses, either active compound or placebo, administered four weeks apart in a double-blind, placebo-controlled design. The trial will assess symptoms over a six-week period following the initial dose.
While the primary objective of the study is to assess the safety and tolerability of the compound in participants with SAD, the secondary objective is to estimate any improvement in social anxiety symptoms of participants compared to placebo.
Dr Shoona Vincent, Vice President of Clinical Science at MAC Clinical Research, commented: “We are pleased to have reached this early milestone and look forward to gathering insights on the compound’s potential impact on social anxiety disorder. This condition significantly affects quality of life, and we’re hopeful that this work brings us a step closer to new and effective treatment options.”
