Phase 2 Trial For This Psychedelic, Potential Treatment For Severe Depression

Private clinical-stage psychedelics biotech Beckley Psytech Ltd. has initiated a Phase 2a proof-of-concept study on BPL-003, its proprietary intranasal formulation of synthetic 5-MeO-DMT for Treatment-Resistant Depression (TRD.)

Founded in 2019 and yet based on more than two decades of pioneering scientific research from the Beckley Foundation, Beckley Psytech’s other most advanced pipeline program focuses on ELE-101, an IV synthetic formulation of psilocin for treating Major Depressive Disorder (MDD.) 

“We are proud to be conducting rigorous scientific investigations into the therapeutic potential of novel, short-acting psychedelic compounds like BPL-003 to help people in urgent need and we are looking forward to dosing the first patient in the coming weeks," CEO Cosmo Feilding Mellen said. "I would like to take this opportunity to thank not only our research partners at King’s and HMR for their support and collaboration but also the many healthy volunteers and future patients that participate in our trials and are willing to contribute to our research program. We at Beckley Psytech are all single-mindedly focussed on the wellbeing of patients and are grateful for their willingness to participate in clinical research.”

This first Phase 2a study is set to take place at King’s College Hospital and Hammersmith Medicines Research, being its prime objective to explore the effects of a single dose of BPL-003 in combination with psychological support in TRD patients with moderate to severe symptoms.

Participants are not allowed to take concomitant antidepressants during the trial’s duration. Furthermore, patients will be followed for 12 weeks after initial dosing through safety, pharmacokinetic (PK) and efficacy assessments. 

“Having been a part of Beckley Psytech's successful Phase 1 studies of 5-MeO-DMT, we are looking forward to exploring the safety, tolerability and efficacy of intranasal BPL-003 in further clinical trials with those suffering with Treatment-Resistant Depression,” said the study’s PI Dr. James Rucker who is a psychiatrist and head of the psychoactive trials group at King’s College London. 

With the first patient expected to be enrolled in January 2023, Dr. Rucker further stated that this new study will inform on the drug candidate’s development pathway for this particular mental health condition.

A second Phase 2a exploratory study investigating the effects of a single dose of BPL-003 alongside abstinence-oriented cognitive behavioral support in people with Alcohol Use Disorder (AUD) is also expected to be initiated in early 2023.

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