Business
LB Pharmaceuticals Initiates Pivotal Phase 3 Trial (NOVA-2) for LB-102 in Patients with Schizophrenia
LB-102 has potential to be the first benzamide approved for schizophrenia in the U.S. NOVA-2 trial to enroll approximately 460 patients Primary endpoint to
About this update from Lb Pharmaceuticals Inc
[{"type":"text","content":"LB-102 has potential to be the first benzamide approved for schizophrenia in the U.S. NOVA-2 trial to enroll approximately 460 patients Primary endpoint to evaluate change in PANSS total score at week 6; secondary endpoints to include evaluations of negative symptoms and cognitive performance as well as safety and tolerability Topline data expected in 2H 2027 NEW YORK, March 25, 2026 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX), a late-stage biopharmaceutical company developing novel therapies for schizophrenia, bipolar depression, adjunctive major depressive disorder (MDD), and other neuropsychiatric diseases, today announced the initiation of its pivotal Phase 3 trial (NOVA-2) evaluating the efficacy and safety of LB-102 as a treatment for schizophrenia. LB-102, a novel, once-daily, oral investigational small molecule, is a selective antagonist of D2, D3, and 5HT-7 receptors that is being advanced as a potential first benzamide in the U.S. for the treatment of neuropsychiatric disorders. “The initiation of the NOVA-2 trial marks a major milestone and underscores our strong and continued focus on execution,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “NOVA-2 is designed to build on the compelling clinical activity and safety profile that LB-102 has demonstrated to date. Based on positive results and prior FDA feedback, we believe NOVA-2, together with the open label extension trial, and data from our Phase 2 (NOVA-1) trial, will support the potential U.S. approval of LB-102 for the treatment of schizophrenia. We believe that LB-102 has the potential to become a mainstay of psychiatric practice by offering patients a balanced clinical benefit and tolerability profile. With our broad development program in both psychosis and mood disorders, we are focused on unlocking the full potential of LB-102.” “There remains significant unmet need for new schizophrenia therapies that provide patients rapid relief from positive symptoms, minimize burdensome adverse effects, and offer potential for improving negative and cognitive symptoms that drive functional impairment. In our robust NOVA-1 trial, LB-102 demonstrated a statistically significant benefit versus placebo in PANSS total score at all doses studied, including rapid onset of effect at week 1 and sustained...