DT120 ODT receives second FDA Breakthrough Therapy designation for MDD

Definium Therapeutics announced the FDA has granted Breakthrough Therapy designation for its DT120 ODT program for Major Depressive Disorder (MDD). This designation follows the positive results from the company's Phase 3 Emerge study, where a single 100 µg dose of DT120 ODT showed an 8.1-point placebo-adjusted improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. This improvement was statistically significant (p<0.0001) and maintained durable efficacy through Week 12.

This marks the second Breakthrough Therapy designation for DT120 ODT, with the first having been granted for Generalized Anxiety Disorder (GAD). The FDA's Breakthrough Therapy designation aims to accelerate the development and review of treatments for serious conditions where preliminary clinical evidence suggests substantial improvement over existing therapies.

Robert Barrow, Chief Executive Officer of Definium Therapeutics, highlighted that this designation, coupled with the Phase 3 Emerge study results, reinforces the potential of DT120 to significantly impact the treatment of serious mental health disorders. He emphasized the company's commitment to advancing therapies that offer rapid and durable benefits across multiple indications, with the goal of expanding treatment options for patients.

DT120 ODT is a proprietary formulation of lysergide (LSD), a classic serotonergic psychedelic. The orally disintegrating tablet utilizes Catalent’s Zydis® ODT fast-dissolve technology, designed for faster absorption, improved bioavailability, and reduced gastrointestinal side effects. Definium Therapeutics is also exploring DT120's potential for post-traumatic stress disorder (PTSD) and other brain health disorders.