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Definium Therapeutics reported that its investigational oral LSD formulation, DT120, met primary endpoints in Phase III trials for generalized anxiety disorder and major depressive disorder. The company reported symptom improvements versus placebo, but the results were presented at a conference and the treatment is not approved; longer-term benefit and regulatory plans remain unclear.
Definium Therapeutics said its investigational orally disintegrating tablet containing lysergide, or LSD, met the primary endpoints in two Phase III trials for generalized anxiety disorder (GAD) and major depressive disorder (MDD). The company reported placebo-adjusted symptom improvements after a single supervised dose, but DT120 remains an investigational treatment and has not been approved for either condition.
In the 214-person Voyage trial for GAD, participants given one 100-microgram dose had an average 11.6-point reduction in Hamilton Anxiety Rating Scale scores from baseline to week 12. The result was statistically significant, and the reported improvement versus placebo at week 12 was 5.4 points. Definium’s chief medical officer, Dan Karlin, and colleagues presented the findings at the Neuroscience Education Institute (NEI) Fall Congress in Colorado Springs.
In the 149-person Emerge trial for MDD, DT120 produced an 8.1-point placebo-adjusted improvement on the Montgomery-Åsberg Depression Rating Scale at week six. The company said the difference remained 7.3 points at week 12. In both studies, statistically significant changes were reported as early as the first week. These are trial findings reported by the developer and presented at a medical conference; the source material does not provide a full peer-reviewed publication.
The trials also reported higher response and remission rates in the DT120 groups than in placebo groups. In Voyage, 43% of participants met the study’s response threshold at week 12, compared with 16% on placebo; remission rates were 14% and 4%, respectively. In Emerge, response at week six was 35% versus 7%, and remission was 24% versus 3%. These measures use each trial’s specified rating-scale definitions and time points.
A Single Supervised Dose, With Open Questions
The results could matter to patients and clinicians because the studies tested a single supervised treatment session, rather than a daily medication regimen. Participants were monitored during dosing: average time until discharge clearance was 6.4 hours in Voyage and 5.8 hours in Emerge, and the trials reported that participants met discharge criteria by eight hours. That makes the treatment model different from medicines taken at home, while also requiring staff, a suitable clinical setting and several hours of patient time.
The reported symptom differences and response rates provide a reason for further study, particularly because many participants had tried previous treatments. In Emerge, 53% had received at least two antidepressants; in Voyage, 36% had tried at least two GAD medications. Still, trial averages do not establish how an individual patient will respond, whether benefits will persist beyond the reported 12 weeks, or how DT120 would compare with available treatments in routine care.
Safety and practical delivery will also shape the treatment’s potential role. The most commonly reported adverse events included illusions, nausea and euphoric mood on dosing day, followed by headache. The findings describe short-term trial experience, not a guarantee of safety outside the study conditions.
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How the Two Trials Were Run
Voyage enrolled people with GAD whose baseline average Hamilton Anxiety Rating Scale score was 27.9; eligibility required a score of at least 20. Participants had an average age of 42, and 64% were women. About 21% reported prior use of any psychedelic, while 9% reported previous LSD experience. The dose was administered in one supervised session, followed by assessments through the 12-week double-blind phase.
Emerge enrolled people with active depressive episodes lasting from eight weeks to 24 months. The average baseline MADRS score was 34.5, and the average age was 44; 54% were men. More than half had previously received at least two antidepressants. The primary comparison was assessed at week six, with follow-up results reported through week 12.
In both trials, the reported adverse events were generally mild to moderate. Voyage reported no serious adverse events, suicidality signals or self-injurious behaviors, and one participant stopped treatment because of an adverse event. Emerge reported no serious adverse events, suicidal behaviors or discontinuations due to adverse events; the company said 99% of reported events were mild to moderate. These safety observations apply to the trial populations and periods described.
“Seeing a clinically meaningful improvement in patients with this level and duration of disease gives us hope that DT120 could offer a new treatment option for people who have been suffering for years and are still in need of better outcomes.”
— Dan Karlin, chief medical officer of Definium Therapeutics, speaking to MedPage Today
Approval and Longer-Term Benefit
The supplied report does not state whether Definium has submitted DT120 to regulators, when it might do so, or what additional evidence regulators may require. DT120 is not described as an approved treatment, and the Phase III findings alone do not establish that it will become available to patients.
Follow-up reported in the trials reached 12 weeks, leaving the durability of benefit beyond that period unknown. The source material also does not provide complete trial protocols, all participant-level results, or a full peer-reviewed account of the findings. Further review will be needed to assess the methods, the full safety record and how the treatment might perform in broader clinical use.
The Next Steps for DT120
The immediate next step is for the full trial data to be examined by researchers, clinicians and regulators. Definium’s regulatory submission plans, any additional studies and a possible application timeline were not specified in the source report. Until those details are available, the findings should be understood as company-reported Phase III results presented at a conference, not a change in current treatment approvals.
Further reporting can clarify whether the results are published in a peer-reviewed journal, what regulators request, and whether longer-term follow-up supports sustained benefit. Any future decision about DT120’s use would depend on regulatory review of its efficacy, safety and supervised-care requirements.
Key Questions
What is DT120?
DT120 is an investigational orally disintegrating tablet formulation of lysergide, or LSD, developed by Definium Therapeutics. In the reported trials, it was given as a single dose in a supervised session.
What did the Phase III trials find?
Definium reported that DT120 met the primary endpoint in both trials. The company reported a 5.4-point placebo-adjusted HAM-A improvement at week 12 in the GAD study and an 8.1-point placebo-adjusted MADRS improvement at week six in the MDD study.
Is DT120 approved for anxiety or depression?
No approval is reported in the source material. DT120 remains an investigational treatment; the report does not say that a regulatory application has been filed.
What side effects were reported?
The most common reported events included illusions, nausea and euphoric mood on dosing day, with headache more common afterward. The company reported that events were generally mild to moderate, but the findings cover the trial settings and follow-up described.
How long were participants followed?
The reported results include assessments through 12 weeks. The source does not establish whether benefits persist beyond that period.
Source: medpagetoday.com
