LB Pharmaceuticals Publishes Phase 2 NOVA-1 Data Showing Rapid Week-1 Onset, Low EPS
LB Pharmaceuticals published JAMA Psychiatry results of its Phase 2 NOVA-1 trial showing placebo-controlled benefit at all doses, rapid week-1 onset, sustained response and low EPS. Its six-week Phase 3 NOVA-2 study is enrolling about 460 patients at 25 US sites, with topline results expected in 2H 2027.
1. Publication of Phase 2 NOVA-1 Results
LB Pharmaceuticals published peer-reviewed Phase 2 NOVA-1 results of LB-102 for acute schizophrenia, demonstrating statistically significant placebo-controlled benefit at all doses, rapid onset by week 1, sustained six-week response, class-leading safety with low EPS, minimal sedation and few gastrointestinal side effects.
2. Ongoing Phase 3 NOVA-2 Trial
The six-week, double-blind, placebo-controlled Phase 3 NOVA-2 trial is enrolling approximately 460 patients across 25 US sites, with topline results anticipated in the second half of 2027 and a pre-NDA FDA meeting planned if data are positive.
3. Additional LB-102 Clinical Programs
LB-102 has advanced into the Phase 2 ILLUMINATE-1 bipolar depression study and plans a Phase 2 adjunctive MDD trial in early 2027, with potential expansion into predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and other neuropsychiatric disorders.