There has been an increase recently of investigation of psychedelic’s in treating mental health disorders. Image credit: Shutterstock / Roman Samborskyi

Vancouver-headquartered MindBio Therapeutics has announced its Lysergic Acid Diethylamide (LSD) based drug MB22001 has reduced symptoms of depression in a Phase IIa trial.

The durability data of the candidate also shows a sustained response in patients with the self-administered micro-dose of LSD. One month post-cessation of treatment, the antidepressant response was sustained with a 65% reduction in depressive symptoms.

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The trial also showed substantial improvements in mood, energy, creativity, well-being, depression and sleep, including REM sleep.

The doses of MB22001 are sub-hallucinogenic to allow patients to go about their normal day.

The trial (ACTRN12623000486628), conducted in New Zealand, also deemed the candidate to be safe, with a good adherence and tolerance profile, which MindBio said was consistent with the Phase I trial.

CEO of MindBio, Justin Hanka said: “We are delighted to discover that MB22001 has shown a sustained antidepressant response one month after cessation of treatment. This is good news for our current dosing in Phase IIb clinical trials underway and further supportive that we have developed a groundbreaking potential new treatment for depression. This data is another small step towards commercialisation.”

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MindBio is running multiple Phase IIb clinical trials including one in major depressive disorder (ACTRN12624000128594), one in advanced-stage cancer patients (ACTRN12623000478617), and is planning a study in pre-menstrual syndrome (PMS) and pre-menstrual dysphoric disorder (PMDD).

According to an update from the company on May 1, 2024, a Phase III trial of the candidate in major depressive disorder is expected to begin in 2025.

Increasing investigation into psychedelics

There has been an increase over the past few years of the number of trials investigating psychedelics. Whilst psychedelics are well established, the use of mind-altering drugs in the treatment of mental health is still in its early days due to issues mostly around public perception.

The US Food and Drug Administration (FDA) disclosed its first guidance on the use of psychedelics in clinical trials in June 2023, setting out a number of measures which sponsors must take.

Elsewhere in the field of psychedelics, the FDA denied approval of Lykos’ MDMA candidate for the treatment of PTSD, while a study found that psilocybin is likely to be effective in treating depression.

Psilocybin is forecast to become the fourth highest-selling psychedelic drug by 2029, according to a GlobalData report.

GlobalData is the parent company of the Clinical Trials Arena.