Issue 153

Dosing begins in 5-MeO-DMT trial for resistant depression

Beckley Psytech has confirmed it has dosed the first patient in its international Phase 2b study of BPL-003 – a novel synthetic intranasal formulation of 5-MeO-DMT – for Treatment Resistant Depression (TRD).

The trial is the largest ever efficacy study of 5-MeO-DMT (also known as Mebufotenin) and is taking place at 40 sites across six countries, with initial study results expected in 2024.

The multi-centre, quadruply-masked Phase 2b study aims to assess the efficacy and safety of different doses of BPL-003 in patients with Treatment Resistant Depression (TRD).

BPL-003 is Beckley Psytech’s patent-protected benzoate formulation of 5-MeO-DMT and is administered intranasally via an FDA-approved delivery device.

PSYCHEDELICS: BENEFITS, REGULATION, AND CONCERNS

Dr Kelan Thomas, psychiatric pharmacist and faculty member of the Touro University California (TUC) College of Pharmacy, discusses the world of drug policy, decriminalization, and the use of psychedelics for therapeutic purposes with TUC.

“The same issues that happened with cannabis rollout will require a lot of public education, such as what’s an appropriate starting dose, what’s way too much, the same type of education will need to happen with psychedelics as well,” he tells the University.

BELIEF IN KETAMINE AS A DEPRESSION TREATMENT

Multiple studies have shown that ketamine is a fast acting treatment for depression, but a key issue with the studies is that many participants can tell if they have been given ketamine or a placebo.

A new study has worked around this by administering participants scheduled for surgery with either ketamine or a placebo when the participants were in surgery and under general anesthesia.

The researchers suggest there may be physiological resonance between the placebo effect — hope — and how ketamine works.

BUSINESS AND INVESTMENT

Cybin Inc. has now completed the acquisition of Small Pharma by way of a plan of arrangement under the Business Corporations Act. Small Pharma is now a wholly-owned subsidiary of Cybin..

Cybin Inc. has also announced that the United States Patent and Trademark Office has issued two patent grants that offer protection for its deuterated N, N-dimethyltryptamine (“DMT”) programme.

Choose Your Horizon has announced the launch of a StartEngine crowdfunding campaign as it continues to expand across the U.S.

Harbour Solutions Importation Inc., a coca leaf company, has announced the launch of an offering of its common shares for gross proceeds of up to US$5 million.

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SCIENCE AND RESEARCH

In The Conversation, researchers at the University of Cambridge discuss how antidepressants, ketamine and psychedelic drugs may make brains more flexible.

The New York Times explores ‘A New Era of Psychedelics in Oregon‘, where “the state has pioneered a therapeutic market for psychedelic mushrooms”.

Several studies are showing psychedelics, including psilocybin and MDMA, as promising treatments for anxiety in cancer patients.

The Brain & Behavior Research Foundation has announced it is awarding $10.2 million in Young Investigator Grants including for projects investigating psychedelics.

REGULATION AND LEGISLATION

In a session on ibogaine for the treatment of addiction, approved by the Food and Drug Administration, a cardiologist said it “couldn’t be done in a reasonable time and the drug is unsafe”, reports The Lexington Times.

A congressional subcommittee’s hearing on the use of psychedelic-assisted treatments for mental health disorders that was originally scheduled for Thursday has been postponed, reports Marijuana Moment.

ARTICLES OF INTEREST

The UK government has announced almost £5 million to fund ‘Early Support Hubs’ nationwide to deliver mental health support for children and young people.

A project has been launched in seven countries across the North of Europe, to combat isolation by promoting inclusion, reports EuroNews.