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Definium's LSD Therapy Shows Promise in Anxiety Treatment
Confirmed
In Short: Definium Therapeutics reported positive results from a second late-stage trial of its LSD therapy, DT120, for anxiety, setting the stage for potential FDA approval.
Definium Therapeutics announced positive results from a second late-stage trial of its LSD therapy, DT120, for anxiety, marking a significant step towards potential FDA approval. According to the company, patients taking a 100-microgram dose of DT120 experienced a 9.8-point drop on the Hamilton Anxiety Rating Scale, compared to a 4.7-point drop for those on placebo.
In the latest trial, known as the Panorama study, DT120 demonstrated a 5.1-point improvement over placebo, similar to the results seen in the company's first late-stage anxiety study. This improvement is notably larger than what has been observed with many other anxiety therapies, though direct comparisons across studies can be challenging.
Definium Therapeutics is among the first biotech companies to near regulatory approval for psychedelic therapies, a class of treatments that offer rapid benefits to patients. Unlike traditional options like antidepressants, which can take weeks to show effects, DT120 reportedly showed changes as early as the second day after dosing.
Analysts from Stifel and Jefferies praised the results, with Stifel calling the findings 'another clear win' for DT120. The company's shares rose 11% following the announcement, reflecting investor optimism. The Panorama trial also met all key secondary endpoints, including improvements in illness severity and anxiety symptoms.
Definium's success in the latest trial comes as the FDA and other stakeholders prepare to discuss the future of psychedelic therapies. The company's third positive result this summer, following successful trials in major depressive disorder, underscores the potential of DT120 as a novel treatment option.
What's confirmed
- Definium Therapeutics announced positive results from a second late-stage trial of its LSD therapy, DT120, for anxiety, marking a significant step towards potential FDA approval. According to the company, patients taking a 100-microgram dose of DT120 experienced a 9.8-point drop on the Hamilton Anxiety Rating Scale, compared to a 4.7-point drop for those on placebo.
- In the latest trial, known as the Panorama study, DT120 demonstrated a 5.1-point improvement over placebo, similar to the results seen in the company's first late-stage anxiety study. This improvement is notably larger than what has been observed with many other anxiety therapies, though direct comparisons across studies can be challenging.
- Definium Therapeutics is among the first biotech companies to near regulatory approval for psychedelic therapies, a class of treatments that offer rapid benefits to patients. Unlike traditional options like antidepressants, which can take weeks to show effects, DT120 reportedly showed changes as early as the second day after dosing.
- Analysts from Stifel and Jefferies praised the results, with Stifel calling the findings 'another clear win' for DT120. The company's shares rose 11% following the announcement, reflecting investor optimism. The Panorama trial also met all key secondary endpoints, including improvements in illness severity and anxiety symptoms.
- Definium's success in the latest trial comes as the FDA and other stakeholders prepare to discuss the future of psychedelic therapies. The company's third positive result this summer, following successful trials in major depressive disorder, underscores the potential of DT120 as a novel treatment option.
What's still developing
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- “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.
- Definium shares were up 11% to 43.50 as the market opened on Monday following the news.
- Fifty-two patients received a 50-ug dose—a cohort that “was not designed or powered for statistical comparisons,” per Definium’s press release.