Definium Therapeutics has released topline phase 3 results for its investigational LSD-based depression treatment, delivering data that is likely to further increase interest in psychedelic medicine.
The company’s LSD formulation, DT120 ODT, successfully met both the primary endpoint and all key secondary endpoints in the 149-patient Emerge study. According to the company, the treatment achieved reductions in depressive symptoms that surpassed those reported for currently available therapies and competing experimental approaches.
Speaking ahead of the announcement, Definium Chief Executive Officer Robert Barrow said the findings represent an unprecedented level of efficacy in a pivotal depression trial. He argued that the treatment demonstrated a combination of rapid onset, substantial symptom improvement and sustained benefit rarely seen in late-stage studies.
Investors reacted positively to the news, with the company’s stock rising more than 30% in premarket trading after the results were disclosed. Definium, which operated under the name MindMed before adopting its new identity in January, highlighted comparisons showing that DT120 produced an 8.1-point placebo-adjusted improvement on the Montgomery-Åsberg Depression Rating Scale (MADRS).
According to materials shared, that outcome exceeded results reported in comparable studies involving marketed antidepressants such as Trintellix and Auvelity, as well as Compass Pathways’ investigational psilocybin therapy. Among the treatments referenced, Johnson & Johnson’s Spravato posted the next strongest result with a 6.8-point reduction. Although direct comparisons across studies are limited by differing designs and patient populations, Definium described DT120 as potentially best in class.
The company also reported encouraging safety findings. No unexpected safety concerns emerged during the study, and investigators did not observe increases in suicidal thoughts or suicidal behavior.
John Sonnenberg, the chief investigator of the trial, said the data suggests the treatment could represent a fundamentally different approach to managing major depressive disorder.
The primary endpoint evaluated changes in MADRS scores six weeks after treatment. At the 12th week, patients maintained a mean reduction of 7.1 points, allowing the study to achieve another important secondary endpoint. Participants are continuing into a 40-week open-label extension designed to further evaluate durability of benefit.
Barrow explained that patients who respond to DT120 often experience significant improvements quickly. The ongoing extension phase is intended to determine whether individuals who do not benefit from an initial dose may respond to additional treatment sessions. He noted that the eventual dosing schedule for any approved product would likely depend on the needs of each patient.
During the study, participants received either a 100-microgram dose of DT120 or placebo and were supervised throughout an approximately eight-hour treatment session. Sonnenberg explained that trained attendants remained with participants to help them navigate potentially intense perceptual, emotional and cognitive experiences associated with the psychedelic state.
Definium’s approach differs from the psychedelic-assisted psychotherapy model being pursued by competitors such as Compass Pathways. Chief Medical Officer Daniel Karlin said the support provided during treatment is intended to ensure maximum patient comfort and safety rather than serve as a therapeutic intervention that directly influences outcomes.
Definium has reported impressive late-stage clinical trial results for its LSD-based therapeutic candidate, marking a significant achievement in the company’s development program. The findings position Definium as an emerging player in the growing field of innovative mental health and neurological treatments.
Definium Achieves a Significant Clinical Milestone
The positive study outcome represents a major milestone for Definium, demonstrating encouraging efficacy and safety results in a late-stage clinical setting. Achieving success at this stage of development is particularly important, as it may support future regulatory discussions and potential commercialization opportunities.
The latest data further validates the scientific strategy that Definium has pursued throughout the development process.
Innovation remains at the center of Definium’s mission. By exploring novel treatment mechanisms and emerging therapeutic platforms, Definium aims to contribute to a new generation of healthcare solutions that can improve patient outcomes.
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