Definium Therapeutics has announced positive topline results from Voyage, its first phase 3 study of DT120 ODT in adults with generalized anxiety disorder. The company said the trial met its primary and all key secondary endpoints.
Participants receiving DT120 ODT achieved a statistically significant reduction in Hamilton Anxiety Rating Scale score, with a placebo‑adjusted change of 5.4 points at Week 12. Definium said efficacy was rapid, with improvements seen as early as Day 2 and sustained throughout Part A.
Rob Barrow, Chief Executive Officer of Definium Therapeutics, said: “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.”
He added: “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.”
Barrow explained: “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.”
DT120 ODT was generally well tolerated, with adverse events mild to moderate, transient and mostly occurring on the day of dosing. No new safety signals were identified, including no suicidality or suicidal behaviour.
Participants were assessed hourly beginning at hour 5 post‑dose using a structured end‑of‑session checklist. Definium said the average time to meeting criteria was 6.4 hours, with 92% of participants meeting the threshold by hour 8.
Brian Barnett, Vice Chair of Psychiatry at Cleveland Clinic and a Voyage principal investigator, said: “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.”
He added: “A single‑dose treatment option delivering meaningful benefits for 12 weeks is a promising step forward not found in today’s therapies.”
