LB Pharmaceuticals Presents New Data from Phase 2 Clinical Trial of LB-102 at the 2025 Annual Congress of the Schizophrenia International Research Society

Treatment with LB-102 resulted in a positive shift in disease severity as measured by mean change from baseline in Clinical Global Impression of Severity (CGI-S) scores

Phase 3 clinical trial of LB-102 in acute schizophrenia expected to initiate in Q4 2025

/EIN News/ -- NEW YORK, March 31, 2025 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing novel therapies for the treatment of neuropsychiatric diseases including schizophrenia, today presented additional positive data from NOVA¹, a Phase 2 clinical trial of LB-102 in acutely exacerbated schizophrenia patients, at the 2025 Annual Congress of the Schizophrenia International Research Society (SIRS) being held in Chicago, Illinois, from March 29 to April 2, 2025.

As previously reported the primary endpoint of NOVA¹, a clinically meaningful change in Positive and Negative Syndrome Scale (PANSS) total score at week 4, was achieved with a high degree of statistical significance at all doses. The study also measured mean change from baseline in Clinical Global Impression of Severity (CGI-S) score, which rates illness severity on a scale from 1 (normal) to 7 (extremely ill) and has been shown to correlate with PANSS, as a secondary endpoint. At week 4 of the study, participants treated with the 50 mg dose (n=107) achieved a mean change in baseline CGI-S score of -0.72 compared to placebo (p=0.0008). Those who received the 75 mg dose (n=108) achieved a mean change in baseline CGI-S score of -0.67 compared to placebo (p=0.0048). Treatment with the exploratory dose of 100 mg (n=36) resulted in a mean change in baseline CGI-S score of -0.84 compared to placebo (p=0.0026).

"The significant improvement in CGI-S scores observed in NOVA¹ reinforces that LB-102 may provide a meaningful clinical impact on disease severity and further validates its strong potential as a next-generation treatment for schizophrenia,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “These results support our vision for LB-102 as a therapy that provides a compelling balance of efficacy and safety, addressing the urgent need for better-tolerated, efficacious therapies for people with schizophrenia. As we advance toward the initiation of a Phase 3 clinical trial in Q4 2025, this data strengthens our confidence in LB-102 as a first-in-class benzamide antipsychotic in the United States.”

Treatment with LB-102 was generally safe and well-tolerated. The most common adverse events were insomnia, headache, anxiety, and agitation, consistent with existing antipsychotics. Increases in prolactin were observed with few clinical adverse events associated with those increases. Modest weight gain was also observed but was not associated with a clinically meaningful signal in metabolic parameters.

John M. Kane, M.D., Professor of Psychiatry and Molecular Medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, the Co-Director of the Institute for Behavioral Science at the Feinstein Institutes for Medical Research, and the Principal Investigator of NOVA¹, added, “These CGI-S scores are compelling. In combination with the statistically significant change from baseline in the PANSS total scores, the findings of NOVA¹ reflect the potential real-world clinical impact of LB-102 on patients with acute schizophrenia. While PANSS scores provide a structured measure of symptom changes, CGI-S offers an independent, clinician-driven, assessment of overall disease severity. The meaningful reductions in CGI-S scores suggest that study participants are experiencing not just statistical improvement, but tangible, clinically relevant benefits that could translate to better daily quality of life. Given the ongoing need for effective and well-tolerated treatment options, these findings further support the potential of LB-102 to help address a critical gap in schizophrenia care.”

About NOVA¹
The Phase 2 randomized, double-blind, placebo-controlled, multi-center inpatient trial enrolled 359 adults, age 18 to 55 with DSM-5 diagnosis of acutely exacerbated schizophrenia. The trial evaluated the efficacy and safety of a once-daily oral dose of LB-102. The primary objective of the study assessed the efficacy of LB-102 versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores at day 28. The secondary objectives of the study included improvement in CGI-S, PANSS subscale and Marder Factor scores, safety and tolerability, and pharmacokinetics. Randomization was approximately 3:3:3:1 as participants received either placebo, 50 mg QD LB-102, 75 mg QD LB-102, or 100 mg QD LB-102.

About LB-102
LB-102 is a potent antagonist of dopamine D_2/3 and 5HT₇ receptors with low off-target activity. In a Phase 2 clinical study of once-daily orally administered, LB-102 meaningfully improved symptoms of schizophrenia. A Phase 3 clinical study is planned to begin later in 2025. Based on the mechanism of action and preclinical studies, clinical trials of LB-102 are being planned in bipolar depression, predominantly negative schizophrenia, and Alzheimer’s agitation/psychosis, in addition to other psychiatric indications. The first of these studies is expected to begin in 2026. If approved, LB-102 would be the first benzamide in the U.S. to treat psychiatric disorders.

About LB Pharmaceuticals
LB Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapies for the treatment of neuropsychiatric diseases, including schizophrenia. The company’s lead candidate, LB-102, is a potential first-in-class benzamide antipsychotic in the U.S. designed to address critical gaps in the current standard of care by providing comprehensive disease management with a generally safe and tolerable profile. LB Pharmaceuticals is backed by institutional investors Deep Track Capital, TCGx Crossover, Vida Ventures, and Pontifax. To learn more, visit our website at https://lbpharma.us/.

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LifeSci Communications
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