Definium Therapeutics announced positive topline results from its Phase 3 Panorama study of DT120 ODT for the treatment of generalized anxiety disorder (GAD). The study successfully met its primary endpoint and all key secondary efficacy endpoints, marking the company's second positive Phase 3 trial for the drug in GAD.
Key Details
- Primary Endpoint: The trial demonstrated a statistically significant reduction in the Hamilton Anxiety Rating Scale (HAM-A) score, with a placebo-adjusted improvement of 5.1 points at Week 12 (p<0.0001).
- Regulatory Timeline: The company plans to hold a pre-New Drug Application (NDA) meeting with the FDA in Q4 2026 and anticipates filing the NDA in the first half of 2027.
- Safety Profile: DT120 ODT 100 µg was reported to be generally well-tolerated, with a safety profile consistent with previous clinical studies. Most adverse events were mild to moderate and occurred on the day of dosing.