LB Pharmaceuticals Kicks Off 460-Patient Phase 3 Schizophrenia Trial for LB-102
LB Pharmaceuticals has launched a pivotal Phase 3 NOVA-2 trial evaluating its oral antipsychotic LB-102 in 460 schizophrenia patients at 25 U.S. sites. The randomized study’s primary endpoint is six-week change in PANSS total score, with topline data anticipated in the second half of 2027.
1. Pivotal Phase 3 Trial Initiation
On March 25, LB Pharmaceuticals launched its pivotal Phase 3 NOVA-2 trial evaluating LB-102 in patients with acute schizophrenia exacerbation. The randomized, double-blind, placebo-controlled study will enroll approximately 460 patients across 25 U.S. sites.
2. Trial Design and Endpoints
Participants will be randomized 1:1:1 to receive 50 mg or 100 mg of LB-102 or placebo over six weeks. The primary endpoint is change from baseline in PANSS total score at Week 6; secondary endpoints include Clinical Global Impression-Severity, PANSS positive and negative subscales, Marder factor scores, cognitive performance, personal and social performance and safety assessments.
3. LB-102 Profile and Prior Data
LB-102 is a once-daily oral antagonist of D2, D3 and 5HT-7 receptors, positioned as a potential first benzamide antipsychotic in the U.S. In Phase 2, it demonstrated statistically significant improvements in PANSS total score at all doses, rapid onset by Week 1, low rates of extrapyramidal symptoms and benefits in negative and cognitive symptom domains.
4. Development Timeline and Next Steps
Topline results from NOVA-2 are expected in the second half of 2027, after which the company plans to hold a pre-NDA meeting with regulators. An open-label extension trial of approximately 900 patients will characterize long-term safety and further explore effects on negative symptoms and cognitive performance.