Definium Therapeutics updates DT120 clinical trials and commercial plans
Definium Therapeutics Inc. (NASDAQ: DFTX) provided updates on its DT120 ODT clinical program for major depressive disorder and generalized anxiety disorder, with three topline data readouts expected within six months. The company also announced plans to expand into posttraumatic stress disorder.
The Emerge study for major depressive disorder enrolled 149 participants and expects topline data in late second quarter 2026. The Ascend study activated sites with first patient dosing anticipated in second quarter 2026, planning to enroll 175 participants.
For generalized anxiety disorder, the Voyage study completed enrollment with 214 participants, with topline data expected in early third quarter 2026. The Panorama study completed sample size re-estimation, updating target enrollment to 200 participants with screening now closed. Topline data is anticipated in late third quarter 2026.
The company announced the Phase 3 Haven study in PTSD, expected to initiate in 2027 with approximately 200 participants. The primary endpoint will use the Clinician-Administered PTSD Scale for DSM-5 at week 8.
DT120 ODT is Definium's proprietary formulation of lysergide tartrate using Catalent's Zydis fast-dissolve technology. The orally disintegrating tablet acts as a partial agonist at serotonin-2A receptors and belongs to the classic serotonergic psychedelics group.
Chief Executive Officer Rob Barrow stated the trial outcomes will inform the company's regulatory approach, including a potential NDA submission path. The company described DT120 ODT as representing a potential multi-billion-dollar commercial opportunity.
Information was provided during the company's investor and analyst day event, according to the press release statement.
