LB Pharmaceuticals to Present Three Posters at 38th ECNP Congress Highlighting Clinical Activity and Safety Profile of LB-102 in Schizophrenia, Including Positive Effects on Cognition and Negative Symptoms

Rhea-AI Summary

LB Pharmaceuticals (Nasdaq: LBRX) will present three posters at the 38th ECNP Congress (Amsterdam, Oct 11-14, 2025) reporting analyses from the Phase 2 NOVA1 trial of LB-102 in acute schizophrenia.

A post-hoc cognitive analysis showed dose-dependent, statistically significant effect sizes versus placebo at 4 weeks: 0.26 (p=0.0476) at 50 mg, 0.41 (p=0.0027) at 75 mg and 0.66 (p=0.0018) at 100 mg in a completer population. Additional posters cover primary NOVA1 efficacy/safety results and a post-hoc analysis on negative symptoms. Posters go live on the company website on Oct 11, 2025.

Positive

• Dose-dependent cognition effect sizes: 0.26/0.41/0.66 at 50/75/100 mg
• Cognition improvements reached statistical significance (p≤0.0476)
• Encore presentation of NOVA1 primary efficacy and safety results
• Poster on negative symptoms in patients with prominent baseline deficits

Negative

• Cognition was an exploratory post-hoc endpoint, not a prespecified primary outcome
• Reported cognition results derive from a completer population, limiting generalizability

NEW YORK, Oct. 06, 2025 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX) today announced that three posters featuring new and previously reported analyses from its Phase 2 NOVA¹ clinical trial of LB-102 in acute schizophrenia will be presented at the 38th European College of Neuropsychopharmacology (“ECNP”) Congress, taking place in Amsterdam, The Netherlands, from October 11-14, 2025.

Among the presentations will be an analysis evaluating the effects of LB-102 on cognition in patients with acute schizophrenia. Cognition was included in the Phase 2 NOVA¹ trial as an exploratory endpoint. Using a validated battery of cognitive tests, this post-hoc analysis demonstrated that after four weeks of treatment with LB-102, a robust, dose-dependent, and significant treatment effect size was identified in a completer population for all doses of LB-102 compared with placebo. The treatment effect size versus placebo was 0.26 (p=0.0476) at the 50 mg dose, 0.41 (p=0.0027) at the 75 mg dose and reached 0.66 (p=0.0018) at the 100 mg dose. The patient population included in this analysis was not enriched for severe cognitive impairment at baseline. Significant effect sizes of the magnitude reported in this trial provide early evidence that LB-102 may positively impact cognitive deficits—an area of significant unmet need not adequately addressed by existing antipsychotics.

In addition to the cognitive findings, the Company will present two additional posters at the 38th ECNP Congress: an encore presentation of the primary efficacy and safety results from the NOVA¹ trial, and a post-hoc analysis focused on the effects of LB-102 on negative symptoms in a subset of patients with prominent negative symptoms at baseline.

Collectively, these analyses further reinforce LB-102’s balanced clinical profile, which is characterized by robust reduction in Positive and Negative Syndrome Scale (“PANSS”) scores, a generally favorable and potentially class-leading tolerability profile, and differentiated clinical activity across multiple symptom domains. We believe these findings support further investigation of LB-102's potential to deliver comprehensive disease management in schizophrenia, beyond just positive symptom control.

“We are pleased to have three abstracts accepted for presentation at ECNP this year, and are especially excited to share the new results on the effects of LB-102 on cognition in schizophrenia—a dataset that expands our understanding of LB-102’s potential clinical utility in this disease,” said Anna Eramo, M.D., Chief Medical Officer of LB Pharmaceuticals and lead author on all three abstracts. “Cognitive impairment is one of the strongest predictors of long-term disability in schizophrenia yet remains largely unaddressed by today’s standard treatments. These results suggest that LB-102 may have the potential to address this critical unmet need.”

Presentation Details

Title: LB-102 for acute schizophrenia in adults: efficacy and safety from a large phase 2 clinical trial
Poster Number: PS02-1273
Date: October 12, 2025
Time: 12:35 - 14:00 p.m.

Title: LB-102 for acute schizophrenia in adults: Results from the phase 2 clinical trial (NOVA¹) with a focus on Negative Symptoms
Poster Number: PS02-1272
Date: October 12, 2025
Time: 12:35 - 14:00 p.m.

Title: LB-102 for cognitive impairment in schizophrenia: exploratory post hoc analyses from a randomised, double-blind, placebo-controlled phase 2 study
Poster Number: PS03-2276
Date: October 13, 2025
Time: 12:35 - 14:00 p.m.

Posters will be made available on the LB Pharma website at https://lbpharma.us/ on October 11, 2025, at the start of the conference.

About NOVA¹

The NOVA¹ Phase 2 trial was a randomized, double-blind, placebo-controlled, multi-center inpatient trial that enrolled 359 adults, age 18 to 55 with DSM-5 diagnosis of acutely exacerbated schizophrenia. The trial evaluated the efficacy and safety of four weeks of treatment with a once-daily (QD) oral dose of LB-102. The primary objective of the study assessed the efficacy of LB-102 versus placebo in reducing 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. Cognition was evaluated as an exploratory endpoint in the trial. 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 Phase 3-ready oral, small molecule and a methylated derivative of amisulpride. In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia. The Phase 2 trial demonstrated statistically significant benefit versus placebo at all doses studied, a potentially class leading safety profile among D2 antagonists and partial agonists, and positive effects on negative symptoms and cognition. LB-102 is advancing into a Phase 3 clinical trial for acute schizophrenia and a Phase 2 clinical trial for bipolar depression. Additional expansion opportunities for LB-102 could include major depressive disorder (MDD), predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as bipolar mania and cognitive impairment associated with schizophrenia.

About LB Pharmaceuticals

LB Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapies for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a potentially attractive alternative to branded and generic therapeutics for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases.

Cautionary Note Regarding Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected clinical development and therapeutic benefits of LB-102 as well as the continuing advancement of LB-102 and the Company’s portfolio. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the Company’s limited operating history and historical losses; the Company’s ability to raise additional funding to complete the development and any commercialization of LB-102; the Company’s dependence on the success of its lead product candidate, LB-102; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company’s lead product candidate, LB-102; any undesirable side effects or other properties of the Company’s product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies.

These and other risks are described more fully in the Company’s filings with the Securities and Exchange Commission (the “SEC”) and its other documents to be subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contacts
Media:
Michael Tattory
LifeSci Communications
Mtattory@lifescicomms.com

Investor Relations:
ir@lbpharma.us

FAQ

When and where will LB Pharmaceuticals present NOVA1 data for LB-102 (LBRX) at ECNP 2025?

Three posters will be presented at ECNP in Amsterdam (Oct 11-14, 2025); posters available on the company website starting Oct 11, 2025.

What cognition results did LB-102 show in the NOVA1 Phase 2 trial (LBRX)?

A post-hoc cognitive analysis after 4 weeks showed dose-dependent effect sizes versus placebo: 0.26 (50 mg), 0.41 (75 mg), 0.66 (100 mg) with stated p-values.

Are LB-102 cognition findings from NOVA1 definitive evidence of benefit for schizophrenia (LBRX)?

No; the cognition analyses were exploratory and post-hoc in a completer population, so findings are preliminary and warrant further study.

What other NOVA1 topics will LBRX present at ECNP 2025?

Presentations include an encore of primary efficacy and safety results and a post-hoc analysis on negative symptoms in patients with prominent baseline deficits.

How can investors access the LB-102 ECNP posters and when?

Posters will be posted on LB Pharmaceuticals' website at https://lbpharma.us/ on Oct 11, 2025, at the conference start.