Definium Therapeutics has once again won in a phase 3 trial of its LSD formula, this time for the treatment of anxiety, which will pave the way for FDA submission next year.
The Panorama trial compared Definium’s DT120 ODT to placebo, but it also compared the 100 μg dose to a 50 μg dose, which is supposed to still be psychoactive but have no therapeutic effect. Panorama enrolled 245 patients.
Robust Efficacy Across Trials and Indications
DT120 easily trounced placebo as it did in the phase 3 Voyage trial a month ago, reducing scores on the Hamilton Anxiety Rating Scale (HAM-A) by 9.8 points at week 12 after treatment compared to 4.7 points for the placebo.
The 100 μg dose arm outperformed the 50 μg arm (not powered for statistical analysis) by 5.1 points over placebo, whereas the 52-patient placebo arm was 3.6 points higher. The previous Voyage trial found 100 µg DT120 to have a 5.4-point placebo-adjusted reduction in HAM-A score.
DT120 also notched a phase 3 win in major depressive disorder in June. It is administered in one 8-hour treatment session supervised by a chaperone who will lead the patient through the effects of the drug.
Addressing Treatment Burden in Generalized Anxiety
Scott Aaronson, chief science officer at Sheppard Pratt’s Institute for Advanced Diagnostics and Therapeutics and investigator in the trial, said in Definium’s release on Monday that “patients with generalized anxiety disorder frequently require two or three drugs before they can be tolerated and, even then, the daily burden of taking these medications is significant.” One of the things that makes DT120 ODT special is that one dose can last for months, and the patient doesn’t need to take a pill daily.
The Panorama trial also hit all of its key secondary endpoints and revealed no new safety concerns, Definium said in the release.
Definium has rescheduled another meeting with the U.S. Food and Drug Administration (FDA) for the fourth quarter to discuss a new drug application for DT120 ODT, Barrow added. While the strategy of which indication to file for first will be hashed out with the agency, Barrow is confident that Definium can prevail in both depression and anxiety.
Those results are pretty reliable, whether the study design is good or bad, or for these two indications, CEO said.
Tackling the Unblinding Challenge in Psychedelic Research
The 50 μg control arm of the Panorama trial was designed to put to bed the fear of functional unblinding in psychedelic trials that was recently raised by the FDA in a new framework presented in the New England Journal of Medicine.
In that regard, Barrow said Definium has been successful. The 50 μg results were similar to those seen in Definium’s prior phase 2 dose-response study, he said.
“In all the doses we tested, they did have some recognition of the effect of the drug when they took it, but there remains some separation in phase 3 between the 100 μg and the 50 μg doses,” Barrow said.
“There is definitely a powerful and real drug effect here at 100 μg that isn’t as strong or lasting at a lower dose,” Barrow said.
Looking Ahead: Expanding Pipeline and Responsibilities
Despite a whirlwind summer, Definium isn’t letting up, Barrow told Fierce. A third trial of DT120 is currently underway – and the New York biotechnology company has plans to conduct a pivotal trial for PTSD next year.
However, Definium has also developed a pipeline that extends beyond DT120, as it is developing its own formulation of MDMA, called DT402, which is in a phase 2 clinical trial in patients with autism spectrum disorder. The company has other drug candidates in the preclinical stage, too, said Barrow.
Definium has achieved another important milestone in the development of its investigational anxiety medication, with the latest study delivering positive results. The outcome marks the third successful study for the program, giving the company additional evidence as it advances clinical development.
The latest findings could strengthen the case for Definium as researchers continue evaluating the potential role of psychedelic-based medicines in treating anxiety-related conditions. Successful clinical studies are particularly important for demonstrating whether an investigational treatment can deliver consistent results across different patient groups and trial settings.
Definium Builds Momentum With Third Study
The three-for-three record represents a notable development milestone for Definium. Repeated positive clinical outcomes can provide researchers with greater confidence in a treatment’s potential while generating additional evidence for regulatory discussions.
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