LB Pharmaceuticals will present findings from its LB-102 Phase 2 trial at the ECNP Congress, focusing on cognition in schizophrenia.
Quiver AI Summary
LB Pharmaceuticals Inc. announced that it will present three posters based on analyses from its Phase 2 NOVA1 clinical trial of LB-102 for acute schizophrenia at the 38th European College of Neuropsychopharmacology Congress in Amsterdam from October 11-14, 2025. A key focus will be on LB-102's effects on cognition, revealing significant improvements in cognitive functioning compared to placebo after four weeks of treatment, particularly at higher doses. Additionally, the company will share results on the primary efficacy and safety of LB-102, as well as its impact on negative symptoms in patients. These findings support LB-102's potential to address cognitive deficits in schizophrenia, which are often neglected in current treatments. LB-102, a new oral medication, is advancing toward Phase 3 trials.
Potential Positives
- Three posters presenting new analyses from the Phase 2 NOVA1 clinical trial of LB-102 will be showcased at the prestigious 38th ECNP Congress, highlighting the importance of the research within the scientific community.
- The analyses demonstrate robust and statistically significant effects of LB-102 on cognitive function in patients with acute schizophrenia, addressing a critical unmet need in the treatment of this condition.
- Results from the trial suggest LB-102 has a balanced clinical profile, with robust efficacy in reducing both positive and negative symptoms, potentially positioning it as a leader among antipsychotic treatments.
- LB-102 is advancing to Phase 3 clinical trials, indicating confidence in its efficacy and safety, as well as the ongoing development of a promising treatment option for multiple neuropsychiatric disorders.
Potential Negatives
- Limited information on the patient population used in the analysis may raise concerns about the generalizability of the findings, as the population was not enriched for severe cognitive impairment at baseline.
- The company has a limited operating history and is heavily dependent on the success of LB-102, which poses a risk if the ongoing Phase 3 trial does not meet expectations.
- The press release includes numerous forward-looking statements, emphasizing uncertainty in the clinical development and commercial prospects of LB-102, which may be interpreted negatively by investors.
FAQ
What is LB-102?
LB-102 is a Phase 3-ready oral medication being developed for treating schizophrenia and other neuropsychiatric disorders.
What were the results of the NOVA1 clinical trial?
The NOVA1 trial showed LB-102 had significant effects on cognition and reduced symptoms of acute schizophrenia compared to placebo.
Where will LB Pharmaceuticals present its findings?
Findings will be presented at the 38th European College of Neuropsychopharmacology Congress in Amsterdam from October 11-14, 2025.
What are the exploratory endpoints in the NOVA1 trial?
Cognition was an exploratory endpoint evaluated using cognitive tests, showing significant improvement with LB-102 at all tested doses.
How can I access the presentation posters?
The posters will be available on LB Pharmaceuticals' website starting October 11, 2025, at the start of the conference.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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 NOVA 1 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 NOVA 1 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 NOVA 1 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 (NOVA
1
) 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 NOVA 1
The NOVA 1 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
[email protected]
Investor Relations:
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