I personally think COMP360 will be the number one prescribed and reimbursable psychedelic drug for many years. Some of these companies will be crushed during FDA review.
Extremely high risk and overvalued
A company-by-company look at the smallest patent footprint of any compound on our tracker — and why Definium, the company furthest along in trials, barely shows up in it.
Definium Therapeutics (Nasdaq: DFTX) — renamed from MindMed in January, its LSD compound renamed from MM120 to DT120 in the same move — is, right now, the most clinically advanced LSD program that exists. DT120 posted a positive Phase 3 result for generalized anxiety disorder in August, on top of an earlier positive Phase 3 readout in major depression, and carries FDA Breakthrough Therapy designation for GAD. Per the same TREA pull behind our tracker, Definium holds exactly 1 granted US patent against 18 pending applications — proportionally the thinnest granted position of anyone mentioned here, on the compound furthest along toward an actual FDA filing.
That's the same asymmetry we found with GH Research and 5-MeO-DMT: the strongest clinical data in the compound class sitting on almost no issued patent protection. It isn't necessarily a weakness. A company this close to an approval is closer to competing on trial data, physician relationships, and regulatory exclusivity than on patent walls — the walls matter more in the years before you have those other things.
Highlights
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Exploratory outcomes from an open-label psilocybin pilot in Veterans with treatment-resistant depression
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Psilocybin produced large, sustained reductions in anxiety scores up to 12 months
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Quality of life and functional impairment improved early but waned later
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PTSD symptoms showed sizable yet variable reductions over follow up
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While improvements in exploratory outcomes tracked with depressive symptom changes, subjective experience measures did not correlate with treatment response
Abstract
Background
Psilocybin has demonstrated promise for improving depressive symptoms in treatment-resistant depression, but its effects on anxiety, quality of life, functioning, and posttraumatic stress symptoms are less well studied. This study reports exploratory findings from an open-label trial in Veterans with TRD.
Methods
Participants received a single 25-mg dose of psilocybin administered with psychological support. The primary endpoint was assessed 3 weeks post-dose, with follow-up extending to 12 months. Outcomes included anxiety severity (GAD-7), quality of life (Q-LES-Q-SF), functional impairment (WSAS), and posttraumatic stress disorder symptoms (PCL-5). Experiential outcomes were measured with the Mystical Experience Questionnaire (MEQ), Challenging Experiences Questionnaire (CEQ-30), and Emotional Breakthrough Inventory (EBI). Mixed-effects models were used to evaluate longitudinal changes, and correlation analyses examined associations between measures and changes in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale.
Results
Fifteen participants were included, with ten completing long-term follow-up. GAD-7 scores demonstrated sustained improvements through 12 months, with a 59% reduction from baseline at Week 3. Q-LES-Q-SF gains were significant through Week 12, with a 24% increase at Week 3, and WSAS improvements persisted through Month 6 before declining, with a 46% reduction at Week 3. These effects were no longer statistically significant after accounting for improvements in depression. Unadjusted PCL-5 reductions were observed at all timepoints. Exploratory analyses of acute subjective experiences did not correlate to treatment response.
Limitations
This study is limited by its small sample size and open-label design.
Conclusions
Psilocybin with psychological support was associated with improvements in anxiety, quality of life, functioning, and PTSD symptoms which largely correlated to concurrent improvements in depressive symptoms.