Definium Therapeutics announced that the first patient has been dosed in Ascend, its second Phase 3 pivotal study evaluating DT120 ODT (lysergide tartrate) for the treatment of major depressive disorder (MDD). The Ascend study will evaluate the efficacy and safety of DT120 ODT versus placebo and is expected to enroll 175 participants in the United States.
Study Design and Clinical Rationale
Ascend is designed in two parts: Part A, a 12-week randomized, double-blind, placebo-controlled, parallel-group period; and Part B, a 40-week extension period during which participants will be eligible for open-label treatment with DT120 ODT based on symptom severity. Participants will be randomized 2:1:2 to receive DT120 ODT 100 micrograms, DT120 ODT 50 micrograms, or placebo. The 50-microgram arm is intended to confound participants’ ability to accurately assess the dose condition to which they have been randomized, aligning with FDA guidance on complementary clinical designs.
The primary endpoint is the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) at Week 6 between DT120 ODT 100 micrograms and placebo. Topline data from the 12-week double-blind period is anticipated in 2027. Ascend builds on positive Phase 2b study results in generalized anxiety disorder, which showed the potential antidepressant effects of DT120. Major Depressive Disorder is the second-most common mental health disorder in the U.S., with over 21 million adults experiencing a major depressive episode annually. Fewer than one-third of patients reach remission with first-line treatments.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/press-releases/definium-therapeutics-announces-first-patient-dosed-in-ascend-the-second-phase-3-pivotal-study-of-dt120-odt-in-major-depressive-disorder