First dose administered in phase 2a psychedelic study for treatment-resistant depression

Key takeaways:

• The first patient in a phase 2a trial of a psychedelic for treatment-resistant depression was dosed.
• Topline results are expected this year.

The first patient with treatment-resistant depression has received a dose of a novel intranasal psychedelic in a phase 2a trial, according to a press release from its manufacturer.

The synthetic formulation of the compound 5-MeO-DMT (BPL-003; Beckley Psytech) has already been shown to be well-tolerated in a phase 1 trial, according to the release from the U.K. biotech company. The phase 2a trial will evaluate the safety, efficacy and pharmacokinetics of BPL-003.

For the study, patients will receive one dose of BPL-003 and be followed for 12 weeks, according to the release.

“Dosing the first patient in this study is hugely exciting, and we are looking forward to exploring the potential therapeutic effects of BPL-003 for patients living with treatment-resistant depression,” Rob Conley, MD, chief scientific officer at Beckley Psytech, said in a release. “Around one-third of all people living with depression are resistant to currently available antidepressants and there is an urgent need for more effective treatments. We are proud to be leading the way in developing alternative therapies that are safe, effective and practical and we hope to have more to share soon.”

Beckley Psytech anticipates results from the study by the end of 2023. These data, along with data from a phase 2b study expected in 2024, will inform future development of BPL-003, according to the release.