Topline results from Voyage, its first Phase 3 study of DT120 (lysergide) Orally Disintegrating Tablet (ODT) 100 µg in adults with generalized anxiety disorder (GAD). The results mark the Company’s second positive DT120 ODT Phase 3 readout, following the positive Emerge results in major depressive disorder (MDD) announced in June.

Voyage met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement from baseline compared with placebo, as measured by the change in HAM-A total score at Week 12. The Least Squares (LS) mean change from baseline in HAM-A total score at Week 12 in participants who received DT120 ODT 100 µg was -11.6 compared with -6.2 for participants who received placebo, an LS mean difference of -5.4 points (p<0.0001), corresponding to a standardized effect size of d=0.81. Efficacy was rapid, with changes seen as early as Day 2 and sustained at all post-baseline timepoints in Part A.

"The unprecedented efficacy demonstrated in Voyage should raise the bar for what patients and clinicians expect from GAD treatments and reinforces our belief that DT120 has the potential to redefine care for the millions of patients in need," said Rob Barrow, Chief Executive Officer 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. With our Panorama topline results in GAD expected in September, we remain focused on bringing this potential new treatment to patients as quickly as possible. We are deeply grateful to the patients, investigators, site personnel, and our team whose commitment made this milestone possible."

DT120 ODT was generally well tolerated, with treatment-emergent adverse events mild to moderate in severity, transient, and predominantly occurring on the day of dosing in Part A. No new safety signals were identified, including no suicidality signal or suicidal behavior.

On the day of dosing, participants were assessed hourly beginning at hour 5 post-dose on a structured end-of-session checklist (EoSC). The average time to meeting EoSC criteria was 6.4 hours for participants receiving DT120 ODT in Part A, with a median of 6.1 hours and 92% of participants meeting the EoSC criteria by hour 8.

"GAD affects approximately 26 million adults in the United States, and when left untreated, can cause chronic, pervasive, and debilitating symptoms that can seriously impact a person’s daily life. It is one of the most undertreated conditions in psychiatry," said Brian Barnett, MD, Vice Chair of Psychiatry at Cleveland Clinic, and a Voyage principal investigator. "Despite the burden of the disorder, the last new FDA-approved treatment for this condition was nearly two decades ago, and many of the patients I see have not found relief despite trying multiple therapies. A single-dose treatment option delivering meaningful benefits for 12 weeks is a promising step forward not found in today’s therapies. If approved, it could give patients and their physicians a treatment option that works through an entirely different mechanism than anything currently used in clinical practice."