Private clinical-stage psychedelics biotech Beckley Cytec Ltd. has initiated a Phase 2a proof-of-concept study on its proprietary intranasal formulation, BPL-003, of synthetic 5-MeO-DMT for treatment-resistant depression (TRD).
Established in 2019 and yet based on more than two decades Leading Scientific Research from the Beckley FoundationBeckley Cytec’s other most advanced pipeline program focuses on ELE-101, an IV synthetic formulation of psilocybin for the treatment of major depressive disorder (MDD).
“We are proud to conduct rigorous scientific investigations into the therapeutic potential of novel, short-acting psychedelic compounds like BPL-003 to help those in urgent need, and we look forward to dosing the first patient in the coming weeks. “ CEO Cosmo Fielding Mellon 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 who take part in our trials and for contributing to our research programme. We here at Beckley Cytec are single-mindedly focused on the well-being of patients and are grateful for their willingness to participate in clinical research.
This first Phase 2A study, to take place at King’s College Hospital and Hammersmith Medicines Research, aims to explore the effects of a single dose of BPL-003 in combination with psychosocial support in TRD patients with moderate to severe symptoms.
Participants were not permitted to take concomitant antidepressants during the duration of the trial. In addition, patients will be followed for up to 12 weeks after the initial dose through safety, pharmacokinetic (PK) and efficacy assessments.
“Beckley has been a part of Cytec Successful Phase I Study of 5-MeO-DMTWe look forward to exploring the safety, tolerability and efficacy of intranasal BPL-003 in further clinical trials with people suffering from treatment-resistant depression,” said the study’s PI Dr. James Rucker, a psychiatrist and is Head of the Psychoactive Trials Group at King’s College London.
With the first patient expected to be enrolled in January 2023, Dr. Rucker added that this new study will inform on the development path of a drug candidate for this particular mental health condition.
A second Phase 2a exploratory study examining the effects of a single dose of BPL-003 along with abstinence-oriented cognitive behavioral support in people with alcohol use disorder (AUD) is also expected to begin in early 2023.