Positive topline results from a second straight study in generalized anxiety disorder shift the narrative for Definium Therapeutics’ DT120 to commercialization, Jefferies analysts said Monday, while Stifel wrote that the asset is moving towards an FDA submission.
Definium Therapeutics’ oral LSD candidate DT120 again helped ease symptoms for patients with generalized anxiety disorder in a late-stage trial, paving the way for an FDA bid in this indication, according to two analyst firms on Monday.
Stifel analysts called the results from the Phase 3 Panorama trial “another clear win” for DT120 that moves Definium closer to a new drug application (NDA) submission.
Definium shares were up 11% to 43.50 as the market opened on Monday following the news.
Topline data reported by Definium on Monday showed Panorama met its primary endpoint, demonstrating a “statistically significant and clinically meaningful improvement from baseline” vs. placebo on the Hamilton Anxiety Rating Scale (HAM-A), which measures the severity of symptoms, at week 12. Patients given a 100-ug dose of DT120 saw a 5.1 change on this scale vs. placebo, which Stifel noted “looks very similar” to the 5.4 improvement seen in the Phase 3 Voyage study in generalized anxiety disorder (GAD) reported last month.
Panorama also hit all key secondary endpoints, Definium reported, including change from baseline score on the Clinical Global Impression-Severity (CGI-S) scale, which measures illness severity, at week 12, change from baseline in HAM-A total score at week 1 and change from baseline in CGI-S score at day 2.
In all, the study comprised 245 participants across 32 study centers. Fifty-two patients received a 50-ug dose—a cohort that “was not designed or powered for statistical comparisons,” per Definium’s press release. Patients in this arm saw a placebo-adjusted change of 3.5 and 3.6 at weeks 4 and 12, some 50% and 29% lower than changes observed among participants who received the 100-µg dose, the company said.
“Although success here was mostly expected, going into the data there was fixation and some worry about the importance of showing a dose response with the lower 50ug arm, and while we’re less sure how important this actually is, Definium was able to check this box,” Stifel wrote.
As for safety, the higher dose “was generally well tolerated,” Definium said, with most treatment-emergent adverse events (TEAEs) mild to moderate in severity, “transient, and predominantly occurring on the day of dosing.” No new safety signals were identified, “including no suicidality signal or suicidal behavior,” the company reported.
The results led Jefferies to push its probability of success for DT120 to between 90% and 95%+ compared to 75% prior to the Panorama readout.
“We envision both a +25-50% stock move and the narrative shifting to commercialization,” the analysts said in a Monday note, predicting a potential FDA approval by the end of 2027.
Definium’s second straight win for DT120 in GAD and third overall this summer—the asset elicited what Jefferies called “profound” efficacy in major depressive disorder in June—comes as the FDA and other stakeholders prepare to discuss the future of psychedelic therapies on Monday afternoon.
The public hearing will include discussion of provider training, patient safety, access issues and best practices for data collection and standardization of psychedelic medications, according to a draft agenda published on the FDA’s site.
The emerging therapeutic class enjoys a wave of public favor heading into the meeting.
“We think key stakeholders already sound supportive,” Jefferies analysts wrote in a note to clients last week, adding that this list includes patients, doctors, interventional psychiatry centers, the FDA and Department of Health and Human Services (HHS), the White House and Veterans Affairs (VA).
