We are evaluating the safety and efficacy of LB-102 for schizophrenia in multiple clinical trials.
Clinical Trials
Phase 2 Clinical Trial of LB-102:
We completed a Phase 2 clinical trial to test LB-102 in patients with acute schizophrenia. This trial (NCT06179108) was designed to evaluate the efficacy and safety of LB-102. Here’s what you need to know:
Trial Details
The trial enrolled patients who had shown clinical response to previous antipsychotic treatments (except clozapine) in the prior 12 months. It was a double-blind, randomized, placebo-controlled trial, meaning neither the patients nor the researchers knew who is receiving LB-102 or a placebo.
Dosing
Patients began with a seven-day period to clear previous medications from their system, then received daily doses of LB-102 (50 mg, 75 mg, or 100 mg) or a placebo for four weeks. We tested different doses to find the most effective and safest option.
Goals Met
The study met its primary endpoint, demonstrating statistically significant change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at 4 weeks with each dose’s effect size meeting or exceeding those of currently approved antipsychotics. LB-102 was also generally safe and well tolerated, and planning for a Phase 3 registrational study is under way.
