Results for Definium Therapeutics psychedelic candidate for major depressive disorder “exceeded expectations,” according to Stifel, while Jefferies called the efficacy data “profound.”
Definium Therapeutics’ oral psychedelic treatment for major depressive disorder met all endpoints in a late-stage trial, sending the company’s stock soaring more than 50% when the markets opened on Monday.
In the Phase 3 trial, DT120—a formulation of LSD—resulted in an 8.1-point placebo-adjusted change from baseline over the course of six weeks along a common scale for depression called the Montgomery-Åsberg Depression Rating Scale, Definium—formerly MindMed—reported on Monday.
And while Stifel analysts were expecting a strong showing from DT120, they wrote in an investor note on Monday that the results “exceeded expectations with clear and highly robust efficacy in the MDD population.”
Furthermore, DT120 maintained its effect over the course of 12 weeks with a 7.3-point reduction on the depression scale, while also showing no new safety signals.
Based on the scale rating, DT120 outperformed all approved therapies, according to Jefferies analysts in a Monday note, who called the efficacy data “profound.”
Definium CEO Rob Barrow called DT120 a “potential best-in-class treatment for mental health disorders” based on the results. The study, dubbed Emerge, is the first of the company’s Phase 3 trials to report. Another ongoing trial is assessing DT120 in generalized anxiety disorder.
“These findings could support a fundamentally new approach to treating MDD for patients and providers who continue to face the limitations of existing treatment options,” Barrow said. “Grounded in decades of scientific research, these results bring us one step closer to potentially delivering a transformative new treatment option as we advance toward FDA submission.”
The long-lasting effect of DT120 gives the drug candidate a “highly compelling advantage vs. Spravato,” Johnson & Johnson’s ketamine-based nasal spray for MDD, according to Stifel. No direct comparison could be made due to the nature of psychedelic trials across different companies, but the durable response speaks to potentially low-frequency dosing that is considered beneficial for psychedelic drugs, the analysts said.
The psychedelics space is quickly gaining steam with several companies making clinical and regulatory strides alongside Definium, including Compass Pathways, which focuses on psilocybin-based therapies for depression.
The FDA has made psychedelics a regulatory priority under the leadership of former commissioner Marty Makary and health secretary Robert F. Kennedy Jr. President Donald Trump signed an executive order last year to push a new wave of psychedelic mental health therapies forward.
Definium changed its name from MindMed in January and is also investigating DT120 in post-traumatic stress disorder. The company also has a formulation of MDMA in autism spectrum disorder, in clinical trials.
