‘A Sea Change’, With Caveats: A Closer Look at Definium’s Phase 3 LSD for MDD Readout
- Out by Hour Six?
- Non-Study Therapy, Past Psychedelic Use
- The Usual Questions: Expectancy, Unblinding and Placebo Response
- Adding the Therapy Back In?
- Benchmarking DT120
- The TRD Question
- Filing Calculus: Part B, Single-Study Guidance and the Voucher
On Monday, Definium Therapeutics announced topline data from a Phase 3 trial of its LSD candidate (DT120) for major depressive disorder (MDD).
Reaction to the topline has been broadly positive, with the company’s stock price appreciating sharply on the news and Definium announcing plans to raise $700M in fresh capital.
Following our reporting of the breaking news earlier this week, we have spoken with experts across the field as well as Definium’s Chief Medical Officer, Dan Karlin, to dive deeper.
Out by Hour Six?
One of the more surprising datapoints included in the topline was that participants who received DT120 cleared the company’s End of Session Checklist (EoSC) in an average of 5.8 hours, with more than half clearing it at 5 hours, the first time point at which the EoSC was administered during sessions. All participants cleared it by hour 8, the company added.
That bucked the expectations of many, given that LSD is a longer-acting classical psychedelic.
It was also surprising given the company’s prior data.
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