Late-stage clinical biopharmaceutical firm Definium Therapeutics, Inc. (NASDAQ:DFTX) has announced highly encouraging topline data from its Voyage trial.
The Phase 3 study evaluated the efficacy of DT120 (lysergide) Orally Disintegrating Tablet (ODT) 100 µg in adults suffering from generalized anxiety disorder (GAD).
The Voyage trial successfully met its primary endpoint, demonstrating a clinically meaningful and statistically significant improvement over placebo.
The update marks the second successful Phase 3 readout for DT120 ODT, arriving shortly after the company reported positive Emerge trial data for major depressive disorder in June.
Rapid And Sustained Symptom Improvement
When measuring the change in the Hamilton Anxiety Rating Scale (HAM-A) total score at the 12-week mark, participants treated with DT120 ODT 100 µg saw a Least Squares (LS) mean reduction of 11.6 points.
In contrast, the placebo group experienced a 6.2-point drop.
This resulted in an LS mean difference of 5.4 points in favor of the therapeutic, establishing a standardized effect size of 0.81.
Notably, patients experienced rapid efficacy, with noticeable symptom changes starting as early as the second day and continuing throughout the evaluation period.
“The unprecedented efficacy demonstrated in Voyage should raise the bar for what patients and clinicians expect from GAD treatments…,” said Rob Barrow, CEO of Definium Therapeutics.
“Importantly, the consistent, large effect size we’ve now observed across three studies underscores the potential of DT120 to transform psychiatry and usher in a new era of mental health care.”
Safety And Tolerability Profile
The therapeutic demonstrated a favorable safety profile and was generally well tolerated by participants. Any treatment-emergent adverse events were categorized as mild to moderate, temporary, and mostly limited to the day of administration.
Researchers observed no new safety concerns, including a complete absence of suicidal behaviors or ideation.
On the day patients received their dose, medical professionals monitored them using a structured end-of-session checklist.
Participants met the required criteria in an average of 6.4 hours, with a median time of 6.1 hours. The vast majority, 92%, successfully met the checklist criteria by the eight-hour mark.
DFTX Stock Price Activity: Definium Therapeutics shares were up 5.72% at $43.25 on Wednesday, according to Benzinga Pro data.
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