MindBio Therapeutics Launches Groundbreaking Clinical Trials for Women's Health

MindBio Therapeutics announced the launch of innovative clinical trials focusing on women's health, specifically targeting the treatment of Premenstrual Syndrome (PMS) and Premenstrual Dysphoric Disorder (PMDD) using their drug MB22001. This drug, a proprietary form of Lysergic Acid Diethylamide (LSD), is designed for self-administered microdosing during specific phases of the menstrual cycle.

The trials, which are approved for take-home use, aim to fill a critical gap in treatment options for approximately 25% of menstruating women who suffer from severe PMS and PMDD. The current treatments, including SSRIs and oral contraceptives, often fail to alleviate symptoms adequately and can lead to significant side effects. MB22001 has shown promising results in earlier phases by improving mood symptoms related to the menstrual cycle.

The studies will include a Phase 1 open-label trial to assess menstrual cycle effects and tolerance, and a more extensive Phase 2 trial focusing on the luteal phase microdosing's effectiveness against placebo. These trials are unique as they aim to explore both the pharmacokinetic and pharmacodynamic effects of a CNS drug across different stages of the menstrual cycle, potentially addressing the need for more gender-specific research in drug effects.