FDA Grants DT120 Second Breakthrough Therapy Designation for Major Depressive Disorder
核心洞察
The FDA has granted breakthrough therapy designation to Definium Therapeutics (搜索)' DT120 Orally Disintegrating Tablet for major depressive disorder (搜索) after preliminary clinical evidence showed significant improvement.
DT120 ODT (搜索), a pharmaceutically optimized LSD formulation, previously received breakthrough therapy designation for generalized anxiety disorder (搜索) and acts as a partial agonist at serotonin-2A receptors.
Definium plans to submit a new drug application to the FDA in the first half of 2027, with a phase 3 trial in post-traumatic stress disorder (搜索) planned to start in 2027.
The FDA has granted breakthrough therapy designation to DT120 Orally Disintegrating Tablet for the treatment of major depressive disorder (搜索), based on preliminary clinical evidence showing significant improvement with a single dose. The drug, developed by Definium Therapeutics (搜索), previously received breakthrough therapy designation in generalized anxiety disorder (搜索). DT120 ODT (搜索) is a pharmaceutically optimized formulation of LSD (lysergide) that works as a partial agonist at serotonin-2A (5-HT2A) receptors, and is designed to be fast-absorbing with improved bioavailability and a lower incidence of gastrointestinal side effects.
Positive topline results from the phase 3, randomized, double-blind, placebo-controlled Emerge study in adults with MDD were announced in June. At week 6, total Montgomery-Åsberg Depression Rating Scale (MADRS) scores improved significantly in the DT120 ODT (搜索) group versus placebo, with effects seen at week 1 and sustained through week 12. Definium also reported positive topline results from the phase 3 Panorama study in GAD, which randomized 245 adults aged 18 to 74 years 2:1:2 to a single 100 µg dose (n = 96), a 50 µg dose (n = 52) or placebo (n = 97). The trial met its primary endpoint on the Hamilton Anxiety Rating Scale, with a least squares mean change at week 12 of –9.8 points for DT120 ODT versus –4.7 points for placebo, an LS mean difference of –5.1 points (P < .0001); the week 1 LS mean difference was –5.3 points (P < .0001).
In both trials, DT120 ODT (搜索) was generally well tolerated, with most adverse effects mild to moderate and mainly occurring on the day of dosing. No new safety signals were identified, including no increase in suicidal ideation or behavior. Next steps include ongoing 40-week Part B extension phases of the MDD and GAD studies, in which participants can receive up to four open-label treatments, and recruitment for Ascend, a second phase 3 study in MDD. A phase 3 trial in post-traumatic stress disorder (搜索) is planned to start in 2027, and Definium intends to submit a new drug application to the FDA in the first half of 2027.