Definium Says Its Anxiety Drug Showed 'Unprecedented Efficacy'

Definium Therapeutics Inc. (NASDAQ:DFTX) on Monday released topline results from Panorama, its second Phase 3 study evaluating DT120 (lysergide) Orally Disintegrating Tablet (ODT) in adults with generalized anxiety disorder (GAD).

This marks the biopharmaceutical firm’s third successful Phase 3 readout for DT120 ODT, following positive results from the Emerge trial in major depressive disorder in June and the Voyage study in GAD in August.

ODTs are solid medications that dissolve on the tongue within seconds without needing water or chewing.

Panorama Meets Primary Endpoint

The study successfully met its primary endpoint, showing a statistically significant and clinically meaningful improvement from baseline compared to placebo on the Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12.

The scale measures the severity of anxiety symptoms.

Patients receiving DT120 ODT 100 µg demonstrated a Least Squares (LS) mean score change of -9.8, versus -4.7 for placebo, yielding an LS mean difference of -5.1 points and an effect size of d=0.64.

Symptom improvements occurred as early as Day 2 and remained sustained across all post-baseline timepoints in Part A.

Session Monitoring And Control Results

Participants underwent a minimum eight-hour monitoring period on dosing day.

Patients receiving DT120 ODT 100 µg averaged 6.2 hours to meet end-of-session checklist (EoSC) criteria, with 94% meeting criteria by hour eight. Across more than 1,000 Phase 3 treatment sessions through Sept. 10, 2026, 97% of participants met EoSC criteria by hour 8.

Additionally, the 50 µg control arm demonstrated placebo-adjusted changes of -3.5 and -3.6 at Weeks 4 and 12, respectively.

Safety And Tolerability Profile

DT120 ODT 100 µg was generally well tolerated, with most treatment-emergent adverse events being mild to moderate, transient, and primarily occurring on dosing day.

The study revealed no new safety signals, suicidality, or drug-related serious adverse events. Discontinuation rates remained similar across treatment and placebo arms.

“The Panorama results again met our high expectations and confirmed the unprecedented efficacy of DT120 in GAD,” said Rob Barrow, CEO of Definium Therapeutics.

“With strong positive results across four complementary studies, we have built a compelling body of evidence that increases our confidence in the potential best-in-class profile of DT120. Building on this momentum, we are advancing toward an NDA submission and look forward to aligning with the FDA at our upcoming pre-NDA meeting,” Barrow further added.

DFTX Price Action: Definium Therapeutics shares were up 3.2% at $40.16 at the time of publication on Monday, according to Benzinga Pro data.

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