Definium doses first patient in Phase 3 Ascend study of DT120 ODT for MDD; topline data expected 2027

Definium Therapeutics, Inc.

First patient dosed in Ascend, second Phase 3 pivotal study of DT120 ODT (lysergide tartrate) for major depressive disorder.
Primary endpoint: change from baseline in MADRS score at Week 6 for DT120 ODT 100 µg vs placebo.
Study to enroll 175 participants in the U.S.; topline data from 12-week double-blind period anticipated in 2027.
Ascend design aligns with Emerge Phase 3 and GAD trials; includes 40-week open-label extension and 2:1:2 randomization.
50 µg DT120 arm included to confound dose condition awareness and address functional unblinding concerns.

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