Key Takeaways:
Definium Therapeutics Inc. said a single 100-microgram dose of its LSD-based pill DT120 reduced symptoms of major depressive disorder by 8.1 points on a standard depression scale versus placebo at six weeks, meeting the primary endpoint of its Phase 3 Emerge study. The Nasdaq-listed shares surged as much as 55% to $37.23, their highest in more than four years.
"The results exceeded expectations with clear and highly robust efficacy in the MDD population," Stifel analysts wrote in a note Monday. Jefferies called the efficacy data "profound," noting DT120 outperformed all approved therapies on the Montgomery-Asberg Depression Rating Scale.
The 149-patient trial enrolled adults aged 18 to 74 across 20 U.S. sites with a confirmed diagnosis of MDD and a baseline MADRS score of at least 26. The drug maintained its effect through 12 weeks with a 7.3-point reduction. About 99% of adverse events were mild to moderate, occurring mainly on the day of dosing, with no serious safety issues or increase in suicidal thoughts observed.
The results position DT120 as a potential competitor to Johnson & Johnson's Spravato, the only other psychedelic-derived treatment approved for depression. Stifel analysts said the durable response gives DT120 a "highly compelling advantage" over Spravato, which requires twice-weekly dosing. Needham analyst Ami Fadia called the efficacy "unprecedented in the depression space," adding that DT120 showed greater score reductions at six weeks than Spravato or Compass Pathways' COMP360 achieved at week four.
Definium, which changed its name from MindMed in January, is running a second Phase 3 depression trial called Ascend that includes a 50-microgram low-dose arm. The company is also studying DT120 in generalized anxiety disorder and post-traumatic stress disorder, and has an MDMA formulation in clinical trials for autism spectrum disorder.
More than 21 million U.S. adults experience a major depressive episode each year, according to the company. Definium said the data bring it closer to an FDA submission. The Ascend study results are the next catalyst for investors to watch.
This article is for informational purposes only and does not constitute investment advice.
