Definium Therapeutics, a late-stage clinical biopharmaceutical company, announced an upcoming webcast to discuss topline results from its Emerge Phase 3 study in major depressive disorder (MDD). The company will host the live webcast on June 22, 2026, at 8 a.m. EDT. During the session, Definium Therapeutics will present updates from its first randomized, double-blind, placebo-controlled Phase 3 clinical study evaluating a single dose of DT120 ODT 100 µg in adults diagnosed with major depressive disorder.
The company focuses on developing a new generation of therapeutics designed to address the underlying causes of psychiatric and neurological disorders. Therefore, the Emerge study represents an important milestone in advancing DT120 ODT through clinical development.
Webcast Details and Participation Information
Definium Therapeutics has opened registration for listeners who want to access the webcast. Additionally, analysts interested in participating in the question-and-answer session can register through the dedicated analyst link provided by the company.
The company will make a replay of the webcast available through the Investor Relations section of the Definium Therapeutics website at ir.definiumtx.com. Moreover, the archived webcast will remain available for at least 30 days following the live event. Participants planning to attend the webcast are advised to join 15 minutes before the scheduled start time.
Emerge Phase 3 Study Overview for Major Depressive Disorder
Emerge is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study. The trial evaluates the safety and effectiveness of a single 100 µg dose of DT120 ODT compared with placebo in participants with major depressive disorder. The study includes two phases. First, Part A consists of a 12-week double-blind treatment period. Subsequently, Part B includes a 40-week open-label extension phase. During this extension period, participants may become eligible to receive DT120 ODT based on the severity of their symptoms.
The Emerge study enrolled 149 participants between 18 and 74 years of age across 20 clinical sites. Furthermore, all participants had a DSM-5-confirmed diagnosis of major depressive disorder. They also met specific clinical criteria, including a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of at least 26 and a Clinical Global Impression–Severity (CGI-S) score of at least 4 during screening and baseline assessments.
The primary endpoint of the study focuses on the change from baseline in the MADRS total score at Week 6. Meanwhile, key secondary endpoints evaluate changes in CGI-S scores at Week 6, Week 12, and Day 2. The study also measures changes from baseline in MADRS total scores at Week 12 and Week 1.
Additional Phase 3 MDD Development Program Updates
Emerge is one of two pivotal Phase 3 studies evaluating DT120 ODT in major depressive disorder. In addition, the second study, named Ascend, follows a similar clinical design while including a lower dose treatment arm. Ascend consists of two parts. Part A includes a 12-week randomized, double-blind, placebo-controlled, parallel-group treatment period. Afterward, Part B includes a 40-week extension period where participants may receive open-label DT120 ODT based on symptom severity. Participants in the Ascend study will be randomized in a 2:1:2 ratio to receive DT120 ODT 100 µg, DT120 ODT 50 µg, or placebo. The 50 µg treatment arm aims to reduce participants’ ability to identify their assigned treatment condition accurately.
This approach builds on Definium Therapeutics’ Phase 2b study of DT120 in generalized anxiety disorder (GAD). The company believes the previous study demonstrated that DT120’s clinical activity was not caused by functional unblinding. Additionally, the design aligns with FDA guidance regarding complementary approaches across clinical development programs. The primary endpoint of the Ascend study is the change from baseline in MADRS total score at Week 6 between participants receiving DT120 ODT 100 µg and those receiving placebo.
Explore Health Tech Insiders for the latest medical innovations and reliable strategic insights driving the future of technology-driven healthcare transformation.
News Source: Businesswire.com
