The FDA granted DT120 (lysergide) ODT Breakthrough Therapy designation for MDD, citing promising phase 3 Emerge data.
Definium Therapeutics has received a second Breakthrough Therapy designation from the
The designation follows an initial Breakthrough Therapy designation for DT120 in generalized anxiety disorder (GAD), positioning the ergoline-derived 5-HT2A partial agonist across 2 psychiatric indications with FDA-recognized potential for substantial improvement over available therapy.¹ Definium is also developing DT120 ODT for PTS.¹ The company did not report new safety data specific to the MDD population in this announcement.¹
"Securing our second Breakthrough Therapy designation, closely following the unprecedented results from our phase 3 Emerge study, underscores the potential of DT120 to meaningfully transform the treatment landscape for people living with serious mental health disorders," said Rob Barrow, chief executive officer of Definium Therapeutics, in a statement.
The Breakthrough Therapy designation is supported by data from the phase 3 Emerge study evaluating a single 100 µg dose of DT120 ODT in adults with MDD.1,2 single dose produced a statistically significant 8.1-point placebo-adjusted improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 6 (P <.0001).¹ Definium reported durable efficacy through week 12 following the single administration.¹
DT120 ODT combines lysergide, the tartrate salt form of LSD, with Catalent's Zydis fast-dissolve technology.¹ The formulation is designed to accelerate absorption and onset of the transient cognitive, perceptual, and affective effects associated with the compound while improving bioavailability and reducing gastrointestinal adverse events relative to earlier formulations.¹ As an ergoline derivative, DT120 acts as a partial agonist at serotonin 5-HT2A receptors.¹
“This recognition of DT120's promise, first in GAD and now in MDD, reinforces the urgency to advance and deliver rapid, durable benefit across multiple indications,” Barrow continued.
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