Definium Therapeutics, Inc. has reported that its drug DT120 met both its primary and key secondary endpoints in the Phase III Panorama trial for generalized anxiety disorder (GAD). The 245-participant study demonstrated a 5.1-point placebo-adjusted improvement on the Hamilton Anxiety Rating Scale (HAM-A) at week 12. Notably, the 100-mcg dose of DT120 produced stronger outcomes compared to placebo, including higher response rates and remission, and effects persisted in patients who had previously undergone multiple treatments for GAD.
Read More
The trial, which consisted of randomized, double-blind assignments in a 2:1:2 ratio to receive either a single 100-mcg dose of DT120, a 50-mcg functional-control dose, or a placebo, showed that DT120 was generally well tolerated, with no new safety concerns or serious drug-related adverse events reported.
Definium plans to meet with the FDA in the fourth quarter of 2023, with an expectation to submit a New Drug Application (NDA) that will cover both GAD and major depressive disorder in the first half of 2027.
Chief Medical Officer Dr. Dan Karlin noted that participants entered the trial with significant disease burden, as reflected by average baseline scores of 28 on the HAM-A and 4.7 on the Clinical Global Impression-Severity (CGI-S) scale, indicating severe anxiety. Half of the participants had already undergone two or more treatments for GAD, with an average diagnosis duration of approximately nine years.
At week four, patients receiving the 100-mcg dose of DT120 exhibited a mean improvement of 12.3 points from baseline on the HAM-A, representing a 7-point placebo-adjusted difference. By week 12, the mean improvement from baseline increased to 9.8 points.