Overview
- Definium said Monday that its Emerge Phase 3 trial met its primary endpoint with a placebo‑adjusted 8.1‑point improvement on the MADRS depression scale at six weeks.
- The company reported large early effects after a single 100 microgram oral dose, with symptom improvement evident at one week and a 7.3‑point placebo‑adjusted effect at 12 weeks.
- Safety data were described as favorable, with roughly 99% of adverse events rated mild to moderate, most occurring on dosing day, and no new safety signals or rise in suicidal thoughts reported.
- Definium plans to use the Emerge data to pursue an FDA submission and Breakthrough Therapy consideration while completing a second Phase 3 trial called Ascend, and investors pushed the stock up sharply on the news.
- DT120 is a pharmaceutical formulation of lysergide (LSD) that acts on serotonin receptors, and experts say independent peer review and the second pivotal trial are still needed before regulators and clinicians can adopt it widely.