Definium Therapeutics (NASDAQ:DFTX) shares jumped 20% in premarket trading on Wednesday after the company announced positive topline results from its Phase 3 Voyage study evaluating DT120 ODT in patients with generalised anxiety disorder.
The trial achieved its primary endpoint as well as all key secondary efficacy endpoints, providing another positive late-stage clinical result for the company’s DT120 ODT development programme.
Participants treated with DT120 ODT recorded a statistically significant improvement on the Hamilton Anxiety Rating Scale, or HAM-A, with a placebo-adjusted change from baseline of 5.4 points at Week 12 (p<0.0001).
DT120 ODT shows significant reduction in anxiety scores
At Week 12, participants receiving the 100 µg dose of DT120 ODT recorded a Least Squares mean reduction of 11.6 points from baseline in their HAM-A total score.
That compared with a decline of 6.2 points among participants receiving placebo.
The treatment also demonstrated a rapid onset of efficacy, with improvements observed as early as Day 2 and maintained across every post-baseline assessment point included in the study.
Phase 3 trial identifies no new safety signals
DT120 ODT was generally well tolerated during the Voyage study.
Treatment-emergent adverse events were predominantly mild to moderate, temporary and mainly occurred on the day participants received their dose.
No new safety signals were identified during the trial, including no signal related to suicidality or suicidal behaviour.
Voyage study enrols 214 participants
The Phase 3 study enrolled 214 adults between the ages of 18 and 74 across approximately 35 clinical sites in the United States.
Participants had a DSM-5-confirmed diagnosis of generalised anxiety disorder and were required to have a HAM-A total score of at least 20 at both screening and baseline.
The mean baseline HAM-A score was 28.4 among participants receiving DT120 ODT and 27.4 for those assigned to placebo.
Definium awaits second Phase 3 GAD readout
The Voyage results represent the second positive Phase 3 readout for DT120 ODT, following favourable results from a study in major depressive disorder announced in June.
Definium is now awaiting topline data from Panorama, its second Phase 3 trial evaluating DT120 ODT in generalised anxiety disorder.
Results from the Panorama study are expected in September, providing the next major clinical catalyst for the programme following the positive Voyage findings.
Definium Therapeutics stock price
