Multiple clinical trials in women’s health approved for take-home use of MB22001
MB22001 aims to address huge unmet need in the ~25% of women experiencing PMS symptoms
MB22001 to be used acutely to address the mood sensitive phases of the menstrual cycle World first clinical trials will assess both the pharmacokinetic and pharmacodynamic responses from a CNS drug across key stages of the menstrual cycle
Mood elevating and antidepressant effects of MB22001 have already been demonstrated in Phase 1 and Phase 2A clinical trials
VANCOUVER, BC / ACCESSWIRE / April 30, 2024 / MindBio Therapeutics Corp. (CSE:MBIO)(Frankfurt:WF6), (the “Company” or “MindBio“), a clinical stage biopharma company developing innovative psychiatric treatments using microdoses of psychedelic medicines to revolutionize mental health treatments, is delighted to announce the regulatory approval of a series of clinical trials in women’s health using MB22001, a proprietary titratable form of Lysergic Acid Diethylamide (LSD) designed for self-administered take home use by patients. 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 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.
More broadly, although inclusion of females in biomedical and clinical research has been mandated for over 30 years by the National Institutes of Health (NIH) – a requirement echoed internationally across funding, ethical and publishing organisations, improving clinical research in females is not as simple as representing the female sex in a random sample. Across the lifecycle of females there are major changes in hormones that are known to affect how drugs act in the body. This has largely been ignored by the pharmaceutical industry. Some work has been completed on how the menstrual cycle affects pharmacokinetics (PK – how the body processes drugs), but almost none on how the menstrual cycle affects pharmacodynamics (PD – how the body responds to drugs). It is perhaps not surprising then that females are disproportionately affected by adverse effects from commonly available medicines [1, 2]. There are next to no clinical trials that have investigated both PK and PD of a Central Nervous System (CNS) drug across the key points of the menstrual cycle making this work significant globally and of interest to all pharmaceutical companies interested in CNS drug trials.
MindBio’s Completed Clinical Trials
In February 2024, MindBio completed its Phase 2a trial of MB22001 in patients with Major Depressive Disorder. In this open label trial, patients experienced a 60% drop in depressive symptoms and 53% of patients entering the trial with MDD, at week 8 were in remission from their depression with a mean 14.1 point drop in MADRS score (Montgomery-Asberg Depression Rating Scale). Prior trial results using MB22001 recorded statistically significant improvements in sleep quality and increases in subjective feelings of “Happiness”, “Social Connectivity”, “Energy”, “Creativity” and “Wellness” with reduced “Anger” and “Irritability”. MB22001 is a promising and potential market disruptive medicine for treating depressive illness.
Chief Executive Officer of MindBio Therapeutics, Justin Hanka said “Microdosing MB22001 is a disruptive treatment methodology, it represents a scalable, affordable and accessible solution using psychedelics to address the global escalation of depression. This is a potential market disruption to first line treatments for depression and conditions such as PMDD. We are the global leaders in psychedelic microdosing and we are strategically positioning MB22001 to replace anti-depressant use with lower side-effects.”
