Definium Therapeutics’ DT120 Hits Phase III Goals in Anxiety Study

Key Points

• DT120 met its primary and key secondary endpoints in Definium’s 245-person Phase III Panorama trial for generalized anxiety disorder, delivering a 5.1-point placebo-adjusted improvement on the HAM-A scale at week 12.
• The 100-mcg dose produced stronger outcomes than placebo, including higher rates of response, mild-or-better disease status and remission, while effects were maintained among patients who had previously tried multiple GAD treatments.
• DT120 was generally well tolerated, with no new safety signals or drug-related serious adverse events. Definium plans to meet with the FDA in the fourth quarter and expects to submit an NDA covering GAD and major depressive disorder in the first half of 2027.

Definium Therapeutics NASDAQ: DFTX reported positive top-line results from Panorama, its second Phase III study of DT120 ODT 100 mcgs in generalized anxiety disorder, or GAD. The company said the single-dose treatment met its primary endpoint and all key secondary endpoints, adding to positive pivotal-study results previously reported in GAD and major depressive disorder.

Panorama enrolled 245 participants in a 12-week randomized, double-blind study. Patients were assigned in a 2:1:2 ratio to receive a single 100-mcg dose of DT120, a 50-mcg functional-control dose, or placebo. The primary endpoint was change from baseline in Hamilton Anxiety Rating Scale, or HAM-A, total score at week 12.

At week 12, DT120 100 mcgs produced a 5.1-point placebo-adjusted improvement on the HAM-A, with a p-value of less than 0.0001, according to the company. The treatment showed an early effect, with a 5.3-point placebo-adjusted HAM-A improvement at week one. Definium also reported a 0.8-point placebo-adjusted improvement on the Clinical Global Impression-Severity, or CGI-S, scale at day two.

Study Results and Patient Outcomes

Chief Medical Officer Dr. Dan Karlin said participants entered the trial with substantial disease burden. Baseline HAM-A and CGI-S scores averaged 28 and 4.7, respectively, which he said placed patients in the severe anxiety range. Half of participants had received two or more previous treatments for GAD, while patients had been diagnosed with the disorder for about nine years on average.

At week four, patients receiving DT120 100 mcgs showed a 12.3-point mean improvement from baseline on the HAM-A, representing a 7-point placebo-adjusted difference. At week 12, the mean improvement from baseline was 9.8 points.

Definium reported the following categorical outcomes for the 100-mcg arm at week 12:

• 32% met the response criterion of at least a 50% HAM-A improvement, compared with 14% on placebo.
• 35% achieved mild-or-better disease status, compared with 17% on placebo.
• 15% achieved remission, compared with 4% on placebo.

Karlin said the week-12 treatment effect was maintained across analyzed subgroups, including participants who had previously received at least two GAD medications.

The trial’s 50-mcg arm was intended as a functional control and was not powered for prespecified statistical comparisons with the other groups. Definium said the lower dose showed a 3.6-point improvement over placebo at weeks four and 12, below the results for the 100-mcg dose. The company said adverse-event profiles and median time to end-of-session clearance were similar between the two active-dose groups.

Safety and Treatment-Session Findings

The company said DT120 was generally well tolerated, with no new safety signals and no study drug-related serious adverse events. Definium also reported no suicidal or self-injurious behavior and no indication of increased drug-related suicide risk.

Treatment-emergent adverse events were reported in 95% of patients receiving DT120 100 mcgs, 96% receiving 50 mcgs and 63% receiving placebo. The company said events were largely mild to moderate, mainly occurred on dosing day, and generally resolved during the supervised treatment session. No treatment-emergent adverse events resulted in discontinuation or death.

Definium uses a structured checklist to determine whether patients are ready to leave the treatment setting. The average time to clearance was 6.2 hours, with more than half of participants clearing at hour six and 92% clearing by hour eight, Karlin said. During the question-and-answer session, he said the company has recorded more than 1,000 DT120 treatment sessions and that 97% of participants across those sessions were ready to leave by hour eight.

Extension Data and Regulatory Plans

Panorama includes a 40-week extension period in which eligible participants may receive up to four open-label DT120 treatments if symptoms recur to a predefined level. Definium presented data through week 28 and said approximately one-quarter of patients initially treated with DT120 100 mcgs remained mild or better for about six months without another dose.

Chief Executive Officer Rob Barrow said the company plans to hold a pre-New Drug Application meeting with the FDA in the fourth quarter and anticipates submitting an NDA for DT120 in the first half of 2027. The meeting is expected to address the filing strategy for both GAD and major depressive disorder, he said.

Management said it intends to pursue a broad label for GAD and MDD if approved, without a fixed redosing interval. The company expects DT120 initially would likely be subject to prior authorization and a requirement that patients have failed two prior drugs, similar to the access approach used for esketamine.

Definium ended the period with approximately $1.1 billion in cash and investments, according to Barrow. The company said it is continuing commercialization preparations, including provider and site engagement, while it advances DT120 toward potential regulatory filings.

About Definium Therapeutics (NASDAQ:DFTX)

Definium Therapeutics, Inc, a clinical stage biopharmaceutical company, develops novel products to treat brain health disorders. The company's lead product candidates include MM120, which is in phase 3 for the treatment of generalized anxiety disorder and attention deficit hyperactivity disorder; and DT402, a R-enantiomer of 3,4-methylenedioxymethamphetamine, which is in phase 2a clinical trials for the treatment of core symptoms of autism spectrum disorder. The company was formerly known as Mind Medicine (MindMed) Inc and changed its name to Definium Therapeutics, Inc in January 2026.

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