Definium Therapeutics Highlights Phase III DT120 Gains in Anxiety and Depression

Key Points

• DT120 produced statistically significant improvements after a single treatment in Phase III trials for generalized anxiety disorder and major depressive disorder, with placebo-adjusted gains of 5.1–5.4 points on HAM-A and 8.1 points on MADRS.
• Ongoing open-label follow-up allows retreatment for patients whose symptoms return; early Part B data show approximately 60%–70% achieving mild symptoms or remission, though full-year durability data are not yet available.
• Definium plans to consult the FDA on its regulatory submission strategy for GAD and MDD. The company also expects DT120’s initial commercial distribution to rely more heavily on white bagging before potentially expanding buy-and-bill access.

Definium Therapeutics NASDAQ: DFTX Chief Medical Officer Dan Karlin said the company’s recent Phase III results for DT120 showed statistically significant improvements in generalized anxiety disorder, or GAD, and major depressive disorder, or MDD, following a single treatment, with longer-term open-label portions of the studies still underway.

Speaking at TD Cowen’s Sixth Annual Novel Mechanisms in Neuropsychiatry Summit, Karlin discussed top-line results from the Phase III VOYAGE and PANORAMA studies in GAD and the EMERGE study in MDD. Each trial included a 12-week randomized, double-blind primary observation period followed by an additional 40-week Part B period that permits open-label treatment under specified conditions.

Phase III efficacy results

Karlin said participants entered the studies with severe symptoms. Patients in the GAD studies had baseline Hamilton Anxiety Rating Scale, or HAM-A, scores of approximately 28, while MDD participants had baseline Montgomery-Åsberg Depression Rating Scale, or MADRS, scores of about 35.

The company sought to limit substantial symptoms associated with the alternate condition—depression among GAD participants and anxiety among MDD participants—to more specifically assess DT120’s effects in each indication, Karlin said.

According to Karlin, a single DT120 treatment produced the following placebo-adjusted changes on the primary endpoints:

• VOYAGE: 5.4-point improvement on the HAM-A at week 12.
• PANORAMA: 5.1-point improvement on the HAM-A at week 12.
• EMERGE: 8.1-point improvement on the MADRS at week six.

Karlin said each result achieved a p-value below 0.0001. He emphasized that participants received no additional DT120 treatment during the primary efficacy periods and no adjunctive psychotherapy, anxiolytics or antidepressants.

In VOYAGE, response and remission rates at week 12 were 43% and 14%, respectively, according to the discussion. PANORAMA reported response and remission rates of 32% and 15%. Karlin said the company’s earlier Phase II trial had shown remission rates approaching 50%, a result he described as unexpected.

While acknowledging differences between individual studies, Karlin said Definium viewed the Phase III results as clinically meaningful relative to existing standards of care. PANORAMA also included a 50-microgram control arm, enrolled at half the rate of the full-dose and placebo groups, intended to help assess the potential effects of functional unblinding.

Open-label retreatment and durability

In the ongoing Part B portions of the trials, participants who reach at least moderate illness severity can receive protocol-specified open-label treatment. Karlin said the retreatment thresholds are a MADRS score of 20 for MDD and a HAM-A score of 16 for GAD.

Based on data released through week six of Part B, Karlin said the availability of additional treatment has led to a convergence in mild-or-remission outcomes of roughly 60% to 70% among treated patients. Most participants have received one to three treatments during the first six months of the open-label period, he said.

Definium has not provided a specific timeline for releasing the full Part B data sets. Karlin said the company intends to share a consolidated view of DT120’s performance across the full year of observation once those data are available.

Under the study protocol, open-label doses cannot be given more often than monthly, and participants may receive up to five treatments over one year. Karlin said the company believes those parameters may encompass the needs of most patients, while noting that prescribing decisions would ultimately involve clinician judgment if the product is approved.

Session duration and discharge assessment

Karlin said the mean and median time to clearance following treatment in the GAD studies was approximately six hours, with 97% of participants cleared by eight hours. The company’s end-of-session clearance checklist assesses decision-making capacity, including whether patients are oriented and able to engage with the world near their baseline level of functioning.

He said the checklist takes less than a minute to administer and was developed through discussions with the U.S. Food and Drug Administration during the development program. Karlin compared the post-treatment supervision and discharge process to procedures involving outpatient surgery or other medical interventions that temporarily alter consciousness.

Regulatory and commercial considerations

Karlin said Definium has breakthrough status for both GAD and MDD and expects to discuss its regulatory path with the FDA at a pre-new drug application meeting. He characterized the meeting as an opportunity to align on the appropriate submission process rather than as a specific risk point.

The company may pursue filings for GAD and MDD either together or through sequential, overlapping submissions, Karlin said. Definium has a second MDD study that is currently recruiting, according to Karlin.

On commercialization, Karlin said Definium expects both white-bagging and buy-and-bill distribution approaches could be relevant for DT120. He said the company anticipates more white bagging initially, with buy-and-bill potentially becoming more common as clinics establish treatment workflows, while aiming to support multiple distribution options.

Karlin also said Definium has not identified demographic or clinical-scale characteristics that can predict in advance which patients will respond to DT120. The company plans to continue evaluating potential predictors of response as additional data accumulate.

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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