Definium Therapeutics has announced positive Phase 3 results for DT120 ODT in generalized anxiety disorder (GAD). The company shared topline findings from its Voyage study in adults with GAD. The results represent the company’s second positive Phase 3 readout for DT120 ODT. Previously, Definium Therapeutics reported positive Emerge results in major depressive disorder (MDD) in June.
The Voyage study achieved its primary efficacy endpoint. In addition, the study met all key secondary efficacy endpoints. Anxiety symptoms were significantly improved in subjects receiving DT120 ODT 100 µg. Researchers used the Hamilton Anxiety Rating Scale (HAM-A) to measure improvement.
LS mean change of -11.6 on the HAM-A was seen in participants taking DT120 ODT at Week 12. The placebo group, meanwhile, had an LS mean change of -6.2. The placebo-adjusted LS mean difference for DT120 ODT was therefore 5.4 points. The difference was statistically significant, p<0.0001. The results also produced a standardized effect size of 0.81. Moreover, the treatment showed an early response during the study.
Researchers observed changes as early as Day 2. The improvements also remained consistent across all post-baseline assessments in Part A. These findings strengthen the company’s clinical development program for DT120 ODT. Furthermore, the results add to the growing clinical evidence supporting the treatment’s potential in psychiatric care.
DT120 ODT Shows Favorable Safety Results
The company said DT120 ODT was generally well tolerated during the Voyage study. Treatment-emergent adverse events remained mild to moderate in severity. The events were also transient and occurred mainly on the dosing day during Part A. Additionally, researchers identified no new safety signals during the study.
The company reported no suicidality signal or suicidal behavior. Therefore, the safety findings remained consistent with previous clinical experience involving DT120 ODT. Researchers also evaluated participants using a structured end-of-session checklist (EoSC). The assessment began five hours after dosing and continued on an hourly basis.
Participants receiving DT120 ODT in Part A reached the EoSC criteria in an average of 6.4 hours. The median time was 6.1 hours.Furthermore, 92% of participants met the EoSC criteria by hour eight. These findings provide additional information about the treatment experience following administration.Rob Barrow, Chief Executive Officer of Definium Therapeutics, highlighted the significance of the Voyage findings.
“The unprecedented efficacy demonstrated in Voyage should raise the bar for what patients and clinicians expect from GAD treatments and reinforces our belief that DT120 has the potential to redefine care for the millions of patients in need,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “Importantly, the consistent, large effect size we’ve now observed across three studies underscores the potential of DT120 to transform psychiatry and usher in a new era of mental health care. With our Panorama topline results in GAD expected in September, we remain focused on bringing this potential new treatment to patients as quickly as possible. We are deeply grateful to the patients, investigators, site personnel, and our team whose commitment made this milestone possible.”
The company expects to report topline results from its Panorama study in GAD in September. Meanwhile, Definium Therapeutics remains focused on advancing DT120 ODT through clinical development. GAD Treatment Landscape and Clinical Potential Generalized anxiety disorder affects millions of adults across the United States. The condition can produce persistent symptoms that interfere with everyday activities.Brian Barnett, MD,Vice Chair of Psychiatry at Cleveland Clinic, also discussed the study findings. Barnett served as a Voyage principal investigator.
“GAD affects approximately 26 million adults in the United States, and when left untreated, can cause chronic, pervasive, and debilitating symptoms that can seriously impact a person’s daily life. It is one of the most undertreated conditions in psychiatry,” said Brian Barnett, MD, Vice Chair of Psychiatry at Cleveland Clinic, and a Voyage principal investigator. “Despite the burden of the disorder, the last new FDA-approved treatment for this condition was nearly two decades ago, and many of the patients I see have not found relief despite trying multiple therapies. A single-dose treatment option delivering meaningful benefits for 12 weeks is a promising step forward not found in today’s therapies. 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.”
The Voyage findings could strengthen interest in new treatment approaches for GAD. In particular, the results highlight the potential of a single-dose therapeutic approach. However, DT120 ODT remains an investigational treatment. Regulatory review and further clinical development will determine its future availability.
Definium Therapeutics is developing DT120 as part of its broader psychiatric and neurological disease pipeline. The company aims to develop therapies that address underlying causes of these disorders. The company also plans to discuss the Voyage findings during a webcast. The webcast is scheduled for 8:00 a.m. EDT today.
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News Source: Businesswire.com
