Definium Therapeutics' (DFTX) Phase 3 Emerge trial of a single 100-microgram dose of DT120 orally disintegrating tablet in major depressive disorder met the primary endpoint along with all key secondary efficacy endpoints, the company said Monday.
The study showed an 8.1-point placebo-adjusted decline in Montgomery-Asberg Depression Rating Scale scores at Week 6 (p<0.0001), meeting the primary endpoint, alongside a 7.3-point placebo-adjusted reduction at Week 12 (p<0.0001) as a key secondary endpoint, the company said.
The company also reported a 14.2-point placebo-adjusted improvement at Week 1 (p<0.0001), indicating rapid onset of effect.
DT120 ODT was generally well tolerated, with mostly mild to moderate adverse events, no serious adverse events and no new safety signals, including no increase in suicidal ideation or behavior, Definium said.
Definium Therapeutics shares were up 32% in premarket trading.