Beckley Psytech said that it has initiated dosing in a Phase 1 trial of its intranasal 5-Methoxy-N,N-Dimethyltryptamine (5-MeO-DMT), a psychedelic compound found in the secretions of certain toads. The company is developing the intranasal formulation for the treatment of treatment resistant depression (TRD).
The single ascending dose study is expected to enroll up to 42 healthy subjects who have no prior experience using psychedelic drugs. According to Beckley, a Phase 2 study of the intranasal 5-MeO-DMT is planned for the second half of 2022.
Beckley Psytech CEO Cosmo Feilding Mellen commented, “The start of this Phase 1 study is hugely exciting for Beckley Psytech and for our continued collaboration with Dr James Rucker and his team at King’s College London. This trial will provide invaluable information about our novel intranasal formulation of 5-MeO-DMT, and we are looking forward to the readout in 2022. Following this trial, we intend to initiate a Phase 2 study in TRD, a condition with a significant unmet medical need. This is another key milestone achieved on our path to deliver on our clinical pipeline.”
Rucker said, “We are pleased to be working with Beckley Psytech and to have initiated this study to evaluate the safety and tolerability of 5-MeO-DMT. TRD is a challenging condition to treat, and it is exciting to be exploring new treatment options that could have a positive impact on patients’ lives in the future.”
Read the Beckley Psytech press release.