Breakthrough in Women's Health CNS drug research, multiple PMS, PMDD clinical trials Approved.
Apr 30, 2024 10:51 am
Hi
Women remain under-represented in clinical trials, compared to men.
A reason often cited, even in our own work, apart from the risk of pregnancy whilst taking an experimental drug, is the varying effects of the menstrual cycle on assessing how the body processes drugs and how the body reacts to drugs over key stages of the menstrual cycle. So, the easy road in scientific research is to set the baseline that includes men only in early stage drug trials and introduce women later.
Quite a suboptimal, inequitable and counter-intuitive process really.
It's no wonder that women are then over-represented in serious adverse events and side effects from approved drugs that are prescribed to them!
It's an unacceptable risk to women's health and I am perplexed by the obvious gap in women's health research and therefore, the missed opportunity.
So, I am pleased that our team have deliberated over this issue and the result is a series of intelligently designed women's health trials testing MB22001 in microdoses during the luteal phase of the menstrual cycle focusing on negative mood symptom alleviation in Pre-Menstrual Syndrome (PMS) and Pre-Menstrual Dysphoric Disorder (PMDD).
PMS and PMDD exist and symptoms emerge exclusively due to the menstrual cycle. A range of PMS symptoms from very normal to more serious are experienced across the population of menstruating persons and the symptoms often are treated with medications.
In the case of PMDD, it is a very serious form of PMS that is included in the DSM for mental health disorders and both PMS and PMDD can be highly disruptive to a person's work, social and familiar relationships and quality of life. The common treatments are anti-depressants and the contraceptive pill, both with varying levels of efficacy and associated serious side effects.
Surprisingly to me, these are thought to be the very first substantial CNS drug trials to assess BOTH the Pharmacokinetic effects AND Pharmacodynamic effects of a CNS drug over key stages of the menstrual cycle. It's certainly a world first in psychedelic clinical trials.
The work will have far reaching effects in women's health and CNS research for the pharmaceutical industry.
Stay Well and stay tuned for exciting upcoming announcements!
JUSTIN HANKA
Chief Executive Officer & Co-Founder
MindBio Therapeutics Corp (Frankfurt: WF6), (CNSX: MBIO)
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