LB Pharma expects NOVA-2 trial results in H1 2027
LB Pharmaceuticals Inc has updated the timeline for its pivotal Phase 3 NOVA-2 clinical trial of LB-102, targeting topline results in the first half of 2027. A pre-NDA meeting with the FDA is anticipated in the second half of 2027. The randomized, double-blind, placebo-controlled trial aims to enroll approximately 460 patients across 25 sites in the U.S. to evaluate the efficacy and safety of LB-102 for schizophrenia.
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LB Pharmaceuticals Inc, a neuromedicines company, announced it now expects to report topline results from the pivotal Phase 3 NOVA-2 clinical trial of LB-102 in patients with schizophrenia in the first half of 2027. The company also plans to schedule a pre-NDA meeting with the FDA in the second half of 2027. This updated timeline is based on current enrollment projections for the study.
NOVA-2 Trial Details
The NOVA-2 trial is a pivotal Phase 3 multi-center, randomized, double-blind, placebo-controlled study. It is evaluating the efficacy and safety of LB-102 for the treatment of schizophrenia. The trial is designed to enroll approximately 460 patients across 25 sites in the U.S.
| Trial Feature | Details |
|---|---|
| Trial Name | NOVA-2 |
| Phase | Pivotal Phase 3 |
| Indication | Schizophrenia |
| Design | Multi-center, randomized, double-blind, placebo-controlled |
| Target Enrollment | Approximately 460 patients |
| Locations | 25 sites in the U.S. |
LB Pharmaceuticals is dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain diseases.
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