Clinical-stage private biotech company Beckley Psytech Ltd has initiated a Phase 2a clinical study on its synthetic formulation of 5-MeO-DMT for the treatment of Alcohol Use Disorder (AUD) and will soon begin patient enrollment.
CEO Cosmo Feilding Mellen said the company’s aim to treat substance use disorders has led them to “the rigorous scientific investigation” on how short-acting formulations like BPL-003 might address and reduce the burden that conditions like alcohol use disorder have on individuals, society and healthcare systems.
Administered intranasally, the novel BPL-003 was well-tolerated with consistent dose delivery and rapidly induced profound psychedelic experiences which were worn off in a brief period in the Phase 1 clinical stage.
Taking place at King’s College Hospital in London, the Phase 2 open-label study will build on that data and further explore the drug’s safety, efficacy and pharmacokinetics through a single dose of BPL-003, paired with an abstinence-oriented cognitive behavioral psychological intervention delivered to patients with AUD.
Safety, pharmacokinetics and efficacy will be assessed several times throughout a 12-week post-dose follow-up period.
Beckley Psytech expects to dose the first trial patient in April 2023 and anticipates preliminary results later in 2023, which will be used with results from its other Phase 2a trial aimed at Treatment Resistant Depression (TRD) to further advance BLP-003.
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Photo: Benzinga edit with photo by PopTika on Shutterstock and Harbin on Wikimedia Commons.
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