Definium Therapeutics reported positive topline Phase III results for its LSD-based depression treatment DT120, an orally disintegrating tablet, showing significant improvement in major depressive disorder.

The company said DT120 significantly reduced depressive symptoms in the Phase 3 trial, signaling strong efficacy.

Outside experts will vet the data, and Definium aims for FDA breakthrough therapy designation to speed review, contingent on robust results from a second Phase III trial (Ascend) and its open-extension phases.

The trial design featured an initial double-blind phase followed by 12 weeks of monitoring, with results indicating rapid, durable relief that may be achievable with a single treatment rather than daily therapy.

Definium is also pursuing DT120 for generalized anxiety disorder, with Phase III results expected later this year, while Ascend trial results remain pending.

Six weeks after a single 100-microgram dose, DT120 produced a 13.3-point reduction on the MADRS scale versus 5.2 points for placebo.

At 12 weeks, DT120 showed an 11-point decrease from baseline compared with a 3.6-point decrease for placebo, indicating sustained benefit with some waning.

In a 149-participant, 20-site study, a single 100-microgram dose of DT120 yielded a greater reduction in depressive symptoms than placebo, with notable gains by week six (8.1-point difference) and higher response/remission rates (35% vs. 7% response; 12% vs. 3% remission).