MindBio Therapeutics Announces Landmark Women’s Health CNS Drug Trials

ASSESSING THE EFECTS OF MICRODOSING MB22001 IN MENSTRUATING PERSONS WITH AND WITHOUT PREMENSTRUAL SYNDROME AND PREMENSTRUAL DYSPHORIC DISORDER 

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.

Foto: Accesswire

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.