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Trial Underway Testing Psychedelic Drug for Depression

Sonoran Desert toad

Sonoran Desert toad (Bighouse2015, Wikimedia Commons.

4 May 2023. The first participant in a clinical trial received a dose of a psychedelic therapy, assessing the experimental compound in people with treatment resistant depression. The study is conducted by Beckley Psytech Ltd., developer of the drug code-named BPL-003, a formulation of the psychedelic compound 5-MeO-DMT, inhaled through the nose.

Beckley Psytech is a four year-old enterprise in Oxford, U.K. spun-off from the Beckley Foundation, a charitable organization funding research on psychedelic medicines. The company is advancing treatments for neurologic and psychiatric disorders with chemical compounds derived from plants and animals used in some cases for centuries to induce mystical or hallucinogenic experiences, but shown in research to affect areas of the brain linked to mental health conditions. Beckly Psytech says it uses digital technologies, including algorithms to discover optimized compounds, as well as personalize treatments and predict patient outcomes. In Aug. 2021, Science & Enterprise reported on Beckley Psytech raising £58 million ($US 80 million) in its second venture funding round.

BPL-003 is the company’s lead program using 5-Methoxy-N,N-dimethyltryptamine or 5-MeO-DMT, a natural compound derived from venom secreted by the Sonoran Desert toad, as well as plants used for centuries by indigenous peoples in South America. 5-MeO-DMT binds to serotonergic receptors in the brain producing the neurotransmitter serotonin that affects mood and other functions, where lack of serotonin is associated with depression. Because of its hallucinogenic effects, 5-MeO-DMT is listed as a controlled substance in the U.S., U.K., and elsewhere.

Individuals with depression not responding to treatments

Beckley Psytech says 5-MeO-DMT requires extensive metabolism, thus it’s not practically administered as an oral drug and even in ancient societies taken as an inhaled vapor. In an early-stage clinical trial with healthy volunteers, says the company, a single inhaled dose of BPL-003 is shown in various levels to take effect in a few minutes, work for a short period, and resolve its hallucinogenic effects within 90 minutes. The company says participants reported no serious adverse effects. (Findings were reported on the Beckley Psytech web site and are not yet peer-reviewed.)

The new clinical trial now underway is a mid-stage study evaluating BPL-003 among 12 individuals in the U.K. with treatment resistant depression, defined as major depressive disorder that does not respond to two or more therapies. Participants are given one inhaled dose of BPL-003, then followed up periodically over 12 weeks.

The study team is looking mainly for adverse effects from BPL-003, including vital signs and changes in electrocardiogram measures, as well as signs of suicidal ideation or behavior. The team is also measuring scores of a standard rating scale of depression symptoms, from two days to 12 weeks after taking BPL-003, including the number who achieve a reduction of at least 50 percent on the scale, as well as those whose condition goes into remission.

Rob Conley, chief scientist at Beckley Psytech says the company is “looking forward to exploring the potential therapeutic effects of BPL-003 for patients living with treatment resistant depression.” Conley adds, “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.”

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