MindBio remains the only company in the world with regulatory approvals for the take-home use of this type of scheduled drug in clinical trials.
Background
Premenstrual syndrome (PMS) is estimated to affect 25% of all persons who menstruate - equivalent to 956 million persons worldwide [1]. A particularly severe form of PMS is termed premenstrual dysphoric disorder (PMDD) which affects 3-8% of persons who menstruate. Collectively severe PMS and PMDD create a massive health burden with negative effects on well-being, employment, social functioning and relationships with partners and children [2]. 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 (or oral contraceptives) [4]. Common side effects of SSRIs when used for PMDD include nausea, decreased energy, somnolence, fatigue, decreased libido and sweating [5] and almost half of persons with PMDD discontinue SSRIs within the first six months of taking them [6]. Similarly, the other main treatment for PMS/PMDD oral contraceptives have limited efficacy and numerous side effects. New treatments for PMS/PMDD are desperately needed.
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 g microdoses of MB22001 b) test for tolerance effects in response to 20 g 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.
More broadly, although inclusion of females in biomedical and clinical research has been mandated for over 30 years by the
MindBio's Completed Clinical Trials
In
Chief Executive Officer of MindBio Therapeutics,
Contact:
Tel: 61 433140886
Email: justin@mindbiotherapeutics.com
Kristina Spionjak
Email: pr@hlthcommunications.com
About MindBio Therapeutics
MindBio is a leading biotech/biopharma company focused on creating novel and emerging treatments for mental health conditions and is conducting world first take-home Microdosing (MB22001) human clinical trials. MB22001 is MindBio's lead candidate drug, a proprietary titratable form of Lysergic Acid Diethylamide (LSD) designed for take-home microdosing. MindBio is a leader in microdosing of psychedelic medicines and is advancing its drug and technology protocols through clinical trials. MindBio has developed a multi-disciplinary platform for developing treatments and is involved in psychedelic medicine development and digital therapeutics, has completed Phase 1 clinical trials in 80 healthy participants and has completed a Phase 2a clinical trial in patients with Major Depressive Disorder, both trials with positive top line data reported. Currently underway are two Phase 2B trials, one in cancer patients experiencing existential distress and another in patients with Major Depressive Disorder. MindBio invests in research that forms the basis for developing novel and clinically proven treatments including digital technologies and interventions to treat debilitating health conditions such as depression, anxiety and other related mental health conditions.
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