other material
confidence high
sentiment positive
materiality 0.70
Relmada reports Phase 3 open-label data for REL-1017 in MDD: rapid, sustained symptom improvement
RELMADA THERAPEUTICS, INC.
- In 204 de novo patients, mean MADRS total score improved 11.3 points at Day 7 and 22.5 points at Month 12.
- Clinical response (≥50% MADRS improvement) achieved by 26.6% at Day 7 and 77.2% at Month 12.
- Remission (MADRS ≤10) rates were 12.1% at Day 7 and 54.4% at Month 12.
- Safety: ~3% discontinuation due to AEs; no new safety signals; common AEs were headache (4.4%), nausea (4.0%), dizziness (2.4%).
- Functional impairment (SDS) improved ~50% by Month 6 in de novo patients.