0001193125-26-218251
SEC filingDefinium Therapeutics announced the first patient dosed in its Phase 3 Ascend study evaluating DT120 ODT for major depressive disorder, with topline data anticipated in 2027.
Definium Therapeutics has dosed the first patient in Ascend, its second Phase 3 pivotal study of DT120 ODT (lysergide tartrate), a proprietary orally disintegrating tablet formulation of LSD, for major depressive disorder. This randomized, double-blind, placebo-controlled trial randomizes participants 2:1:2 to DT120 ODT 100 µg, 50 µg, or placebo, with the 50 µg arm designed to maintain blinding per FDA guidance. The primary endpoint measures the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) at Week 6 for the 100 µg dose versus placebo, building directly on positive Phase 2b data in generalized anxiety disorder that demonstrated antidepressant potential without functional unblinding. Expected to enroll 175 U.S. participants, Ascend mirrors the design of the Company's first Phase 3 MDD study, Emerge—topline results anticipated in late 2Q 2026—and Phase 3 GAD trials like Panorama. Chief Medical Officer Daniel R. Karlin highlighted DT120 ODT's potential as a transformative MDD treatment addressing unmet needs in remission rates, onset speed, and tolerability. With topline Ascend data due in 2027, this milestone advances Definium's pipeline targeting psychiatric disorders including GAD, MDD, and PTSD, supported by multi-layered IP protection.