Definium Therapeutics Inc (DFTX) Study result summary

Unmet need and study background

• Generalized anxiety disorder (GAD) prevalence has increased from 3% to 10% over 20 years, with no new drugs approved since 2007.

• GAD imposes significant impairment in daily functioning, work productivity, and quality of life.

• GAD remains a significant unmet need, with little innovation since 2007.

Study overview, design, and population

• Panorama was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating DT120 ODT 100 µg, 50 µg, and placebo in adults with GAD.

• The study included a 12-week double-blind period and a 40-week open-label extension, with up to four additional doses based on symptom severity.

• 245 participants aged 18–74 were randomized; baseline characteristics reflected severe anxiety and high prior treatment burden.

• No psychotherapeutic intervention was provided; participants were tapered off background medications before enrollment.

• The primary endpoint was change from baseline in HAM-A total score at week 12, assessed by independent central raters.

Efficacy results

• DT120 ODT 100 µg achieved a statistically significant placebo-adjusted reduction in HAM-A score of 5.1 points at week 12 (p<0.0001, Cohen's d=0.64); rapid efficacy was observed as early as day 2.

• Key secondary endpoints were met, including significant improvements in CGI-S and early HAM-A scores.

• At week 12, response and remission rates were higher for DT120 ODT 100 µg (response: 32% vs 14%; remission: 15% vs 4% vs placebo).

• Efficacy was consistent across subgroups, including those with multiple prior GAD treatments.

• The 50 µg dose showed less efficacy and did not meet the efficacy target; dose response was consistent with prior studies.