- Mind Medicine Inc’s (NASDAQ:MNMD) collaborators have released topline data from a double-blind, investigator-initiated trial evaluating lysergide major depressive disorder (MDD).
- The topline data demonstrated significant, rapid, durable, and beneficial effects of lysergide and its potential to mitigate symptoms of MDD.
- The high-dose lysergide regimen in which patients received 100 µg on their first treatment day and 200 µg on a second treatment day (separated by four weeks) resulted in statistically and clinically significant improvements on the primary endpoint, a change in clinician-rated Inventory of Depressive Symptomatology (IDS-C) scores six weeks after the first administration as compared to control.
- IDC-C scores measure behavioral manifestations and severity of depression.
- Related: MindMed Reports Full-Year 2022 Financial Results, Highlighting Anxiety & Autism Studies.
- The control group in this study received a lower dose regimen of 25 µg on both treatment days.
- Patients in the high dose arm (n=28) demonstrated a least square mean change from baseline in IDS-C scores of -12.9 points compared to -3.6 points in the lower dose arm (n=27, p=0.02).
- The statistically significant benefit measured by IDS-C was maintained up to 16 weeks after the first administration compared to the placebo (p=0.008).
- Secondary endpoints were also encouraging.
- The investigational drug was generally well tolerated.
- The company said that improvements observed in this study reinforce preliminary findings that have shown the clinical potential of lysergide in anxiety, depression, and other brain health disorders.
- Price Action: MNMD shares closed at $3.10 on Thursday.
Lipocine Announces Realignment And Forward Focus On Treating CNS Disorders; Announces Planned Monetization Of Non-Core Assets Through Partnerships
Company to apply its proprietary Lip'ral oral drug delivery technology to advance a pipeline of differentiated products for Central Nervous System (CNS) disorders
Initial focus on oral delivery of neuroactive