MindBio Therapeutics Announces Landmark Women’s Health CNS Drug Trials - Seite 2

MB22001 is a proprietary titratable form of Lysergic Acid Diethylamide (LSD: A psychedelic medicine), designed for take-home self-administration by patients. The Company's thesis is that MB22001 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 persons self-medicating for PMS/PMDD using LSD microdoses (e.g. [3]).

MindBio has two significant women's health trials approved:

An open-label trial to test menstrual cycle effects and tolerance to MB22001 microdosing in healthy people with a menstrual cycle (MDMENS). MDMENS is an open-label counter-balanced Phase 1 trial with sequential visits. The purpose of MDMENS is to a) test for menstrual cycle effects in response to 20 μg microdoses of MB22001 b) test for tolerance effects in response to 20 μg microdoses of MB22001 and to c) serve as a pilot and control group for the second approved trial known as the MDPMD trial.

The MDPMD trial is a randomised, triple-blind, placebo-controlled, parallel groups, trial of MB22001 microdosing in persons with Premenstrual Syndrome (PMS)/Premenstrual Dysphoric Disorder (PMDD). The primary hypothesis to be tested in the MDPMD trial is whether a regimen of luteal phase focussed microdoses can reduce symptomatology in persons with PMS/PMDD with superiority to placebo. MDPMD will be triple-blinded with participants, investigators and outcome assessors blinded to the intervention. All participants in MDPMD will have the option of entering a three-cycle open-label extension period to test for long-term durability and safety.

The research team for MindBio's women's health trials includes leading menstrual cycle researchers from three continents.

Broader Significance of MindBio's Women's Health Trials

To our knowledge MDMENS will be the first study to investigate the response to psychedelics across the menstrual cycle. Given the changes in serotonin receptor and transporter densities that occur across the menstrual cycle [4-6] this is a glaring knowledge gap that MindBio's studies will fill. The data collected from these series of trials will add significantly to MindBio's massive repository of data and should be of considerable interest to all companies/researchers interested in psychedelic medicine.