Clinical Trial To Assess LSD Microdosing For PMS

An Australian biopharma company said Thursday that it has received approval to begin a series of clinical trials for its LSD microdosing drug designed as an aid to women’s health.
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MindBio Therapeutics Corp. said that “MB22001, a proprietary and self-titratable form of Lysergic Acid Diethylamide (LSD) designed for safe take home microdosing” has been approved for take-home use in a pair of clinical trials.

“The trials in women’s health aim to address a huge unmet need in effectively treating Pre-Menstrual Syndrome (PMS) and Pre-Menstrual Dysphoric disorder (PMDD) without the side effects of anti-depressants and the combined oral contraceptive pill often used in treatment,” the company said in a press release.

The company “now has in its portfolio, multiple Phase 2B clinical trials underway and in a series of world firsts,” the press release said.

“This month, MindBio aims to present secondary data relating to its recently completed Phase 2A trial of MB22001 in patients with Major Depressive Disorder. The Company has already met its primary end-point using the global standard Montgomery-Asberg Depression Rating Scale (MADRS) to show a 60% drop in depressive symptoms and 53% complete remission from depression by week 8 of treatment,” the company said in the release. 

“The secondary data presentation will report on post treatment effects, using the MADRS and several other vital clinical scales for measuring the effects of MB22001 on each clinical trial participant’s mental health. The readouts are important to understanding the full impact on patients of this novel medicine and if the results continue to be positive, strengthening the position of this drug as it progresses towards Phase 3 clinical trials.”

As Benzinga explains, MindBio’s thesis “is that it can be used acutely during specific periods of the menstrual cycle, with targeted dosing to treat negative mood symptoms.” 

“This thesis is based on three main facts a) The acute dose day mood-elevating effects of MB22001 have been demonstrated in MindBio’s Phase 1 trials b) MindBio’s Phase 2a open-label trial in depressed patients show long-term improvements in mood and c) reports in the grey literature of people self-medicating for PMS/PMDD using LSD microdoses,” Benzinga said. “Premenstrual syndrome (PMS) is estimated to affect ~25% of all women who menstruate – equivalent to 956 million women worldwide. A particularly severe form of PMS is termed premenstrual dysphoric disorder (PMDD) which affects 3-8% of women who menstruate. Current treatments for these issues are selective serotonin reuptake inhibitors (SSRIs), given either continuously or daily during the luteal phase of the menstrual cycle. While SSRIs can be effective for some with PMDD approximately 40% of women with PMDD do not respond to SSRIs, and common side effects of SSRIs when used for PMDD include nausea, decreased energy, somnolence, fatigue, decreased libido and sweating.”

MindBio bills itself as a “pioneering clinical studies into the microdosing of psychedelic medicines to treat a range of medical conditions such as depression, anxiety, PTSD, panic disorder, chronic pain and opiate addictions,” and that invests in “clinical research to discover potential new treatment options and we aim to create novel medicines and treatment regimes from breakthrough microdosing studies.”

The company provides more background on this year’s clinical trials of MB22001.

“Phase 2a clinical trials completed in March 2024 using MB22001 in Major Depressive Disorder.  The Phase 2a clinical trial resulted in 53% of depressed patients entering the trial being in complete remission after 8 weeks of treatment. Overall, there was a 14.1 drop in MADRS Score (Montgomery-Asberg Depression Rating Scale). The MADRS is a global standard for measuring the severity of Clinical Depression. Overall there was an impressive 60% drop in Depressive symptoms at week 8 of the trial,” the company explains, adding that it has “just started dosing in a Phase 2b depression trial.”  

“In this randomised active placebo-controlled trial, 90 patients with Major Depressive Disorder will be given microdoses of MB22001 or an active placebo over an 8 week period.  At the end of the 8 weeks, all participants in the placebo and drug group will be offered an 8 week extension to ensure the placebo group has the opportunity to trial MB22001,” it continues. “A second Phase 2b trial in late stage cancer patients is also currently underway.  This cancer study will evaluate the feasibility of conducting a randomised controlled trial comparing psychedelic-microdose assisted Meaning-Centred Psychotherapy to standard Meaning-Centred Psychotherapy in people who have advanced cancer and anxiety or depression.”

Participants in the trials “will be randomised to receive psychotherapy alongside doses of either an LSD microdose or placebo,” MindBio said. 

“The feasibility, acceptability, safety and potential psychological benefits of this intervention will be assessed. Our findings will inform the development of a larger trial and provide an initial indication of the potential benefits of psychedelic microdosing in advanced cancer.”

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