Definium Therapeutics says its experimental LSD-based therapy DT120 has delivered positive results in a second Phase 3 clinical trial, this time involving patients with generalized anxiety disorder. The findings add to earlier late-stage results in major depression as the company prepares for another anxiety study readout and potential discussions with U.S. regulators.
DT120 Meets Key Goal in Phase 3 Anxiety Trial
The 214-patient Voyage trial compared a psychoactive treatment session using Definium’s DT120 orally disintegrating tablet, or ODT, with placebo.
At 12 weeks, patients receiving DT120 recorded an 11.6-point reduction in anxiety symptoms, compared with a 6.2-point decline among those receiving placebo. Researchers measured symptoms using the Hamilton Anxiety Rating Scale, commonly known as HAM-A.
The difference between the groups was 5.4 points.
“We have never seen a pivotal study deliver greater than five-point placebo-adjusted change on the HAM-A, and we did this 12 weeks after a single dose of drug,” Definium CEO Robert Barrow said.
Barrow described the improvement over placebo as “a sea change” for the treatment prospects of people with anxiety.
“This opens the door to an entirely new expectation,” he said.
Results Follow Positive Depression Study
The latest findings mark the second positive Phase 3 result reported for DT120.
Definium previously announced late-stage data involving patients with major depression. At the time, Barrow characterized those results as particularly strong compared with previous pivotal depression studies.
“If ‘pretty good’ encompasses the best data ever seen in a pivotal study of depression, I think we would say pretty good,” Barrow said when discussing the results in June.
The two studies give Definium evidence for DT120 across separate psychiatric conditions, although the investigational treatment would still require regulatory review before it could become available to U.S. patients.
Researchers Point to Need for New Anxiety Treatments
Generalized anxiety disorder is commonly treated with several types of medication, including antidepressants and benzodiazepines.
Barrow argued that existing options leave substantial room for improvement. Benzodiazepines can carry dependence and addiction risks with prolonged use, while serotonin reuptake inhibitors are also widely used for depression and can require ongoing treatment.
Cymbalta, developed by Eli Lilly, received U.S. Food and Drug Administration approval for generalized anxiety disorder in 2007.
Single-Dose Approach Could Offer Different Option
Brian Barnett, M.D., vice chair of psychiatry at Cleveland Clinic and principal investigator for the Voyage trial, said some patients continue to experience symptoms despite receiving multiple treatments.
“Many of the patients I see have not found relief despite trying multiple therapies,” Barnett said in Definium’s announcement.
“A single-dose treatment option delivering meaningful benefits for 12 weeks is a promising step forward not found in today’s therapies,” he added. “If approved, it could give patients and their physicians a treatment option that works through an entirely different mechanism than anything currently used in clinical practice.”
DT120’s potential durability is an important part of Definium’s development strategy, with the Voyage results measuring benefits 12 weeks after a single treatment session.
Another Phase 3 Anxiety Trial Is Next
Definium’s next major test will come from Panorama, another Phase 3 anxiety study expected to report results next month.
Unlike Voyage, Panorama includes an additional control arm in which participants receive a lower dose of the LSD-based therapy.
Barrow said the design is intended to make it more difficult for participants to determine whether they received the therapeutic dose based on psychoactive effects.
“It’s just there to basically try to confuse people so that if they feel the effects of the drug, they can’t be sure it’s the real dose of drug,” he explained.
The Panorama findings could provide additional evidence on DT120’s effectiveness and help address questions surrounding clinical trial blinding, an important issue in studies involving psychedelic compounds whose noticeable effects can make treatment assignments easier for participants to guess.
Definium Looks Toward FDA Discussions
Barrow said the company believes the results accumulated so far provide compelling evidence across anxiety and depression.
“We now have two very compelling studies across anxiety and depression,” he said. “These are high need, high priority indications.”
“We feel very, very good about the constructive dialog we’ve had with FDA and where that leads us going forward,” Barrow added.
Definium’s results arrive amid growing U.S. pharmaceutical industry interest in psychedelic medicines. Investment and acquisition activity in the sector has increased as developers investigate psychedelic compounds for depression, anxiety and other psychiatric conditions.
For DT120, the upcoming Panorama results represent another significant milestone. Positive findings could strengthen Definium’s clinical package as it evaluates the regulatory path for an unconventional single-dose treatment aimed at two major mental health conditions.
Herman Melville is a contributor at TechNewsInc, covering a diverse range of topics including news, politics, business, technology, sports, entertainment, and lifestyle. He focuses on clear, reliable reporting and useful information, helping readers stay informed about current affairs and developments through relevant, accessible, and engaging stories.
