LB Pharmaceuticals accelerates Phase 3 NOVA-2 timeline across 25 U.S. sites, targets 1H 2027 topline
LB Pharmaceuticals now expects topline results from its pivotal Phase 3 NOVA-2 trial in schizophrenia in the first half of 2027, moving up from the previous guidance of the second half of 2027, due to faster-than-expected patient enrollment, with a pre-NDA FDA meeting planned for the second half of 2027. The NOVA-2 trial is a multi-center, randomized, double-blind, placebo-controlled study enrolling about 460 patients across 25 U.S. sites, comparing 50 mg and 100 mg of LB-102 to placebo for six weeks. The primary endpoint is the change in PANSS total score at week six, with secondary endpoints including CGI-S, PANSS subscales, Marder factor scores, cognitive performance, and PSP. LB-102, a benzamide antipsychotic, is designed to improve brain penetration while antagonizing dopamine D2/D3 and serotonin 5-HT7 receptors, aiming to offer a favorable efficacy-tolerability balance. An open-label extension trial of roughly 900 participants is planned to assess long-term safety and impact on negative symptoms and cognition, alongside Phase 2 efforts in bipolar depression and adjunctive major depressive disorder with topline data anticipated in 2028–2029. The company asserts a cash runway into the second quarter of 2029 to support multiple clinical readouts and other initiatives.
