The Australian-based biopharma company MindBio Therapeutics Corp. (CSE:MBIO) obtained regulatory approval for a series of clinical trials in women's health using its proprietary LSD drug, MB22001. The company said it is the only one in the world with regulatory approvals of the take-home use of this type of scheduled drug in clinical trials.

MB22001 is designed for take-home self-administration by patients. The company'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.

The Two Trials Approved

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 obtained approvals for two women's health trials:

• An open-label trial to test menstrual cycle effects and tolerance to MB22001 microdosing in healthy people with a menstrual cycle (MDMENS).

• The MDPMD trial is a randomized, double-blind, placebo-controlled, parallel groups, trial of MB22001 microdosing in persons with Premenstrual Syndrome (PMS)/Premenstrual Dysphoric Disorder (PMDD).

The research team for MindBio's women's health trials includes leading menstrual cycle researchers from three continents. To the company's knowledge, MDMENS will be the first study to investigate the response to psychedelics across the menstrual cycle.

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