LB Pharmaceuticals Presents New Preclinical Data Supporting LB-102’s Bimodal Mechanism of Action and Highlights Ongoing Late-Stage Clinical Development Programs at the 39th ECNP Congress
NEW YORK, Oct. 10, 2026 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX), a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain disorders, today announced the presentation of four posters at the 39th European College of Neuropsychopharmacology (ECNP) Congress, taking place in Munich, Germany from October 10-13, 2026. The posters highlight new preclinical data describing LB-102’s differentiated mechanism of action, the pivotal program of LB-102 in schizophrenia (NOVA-2 and NOVA-3), the ongoing late-stage development of LB-102 in bipolar depression (ILLUMINATE-1), and a previously reported analysis of LB-102’s impact on cognitive performance from the Phase 2 NOVA-1 trial in schizophrenia.
“Our continued progress in the late-stage development of LB-102 for schizophrenia and mood disorders is reflected in the breadth of our presentations at ECNP this year,” said Susan G. Kozauer, LB Pharmaceutical’s Chief Medical Officer. “We are encouraged by the new preclinical data that provide further insights into the emerging clinical and tolerability profile of LB-102. These data strengthen the scientific rationale for the development of LB-102 in mood disorders and highlight a potential mechanism for addressing symptoms such as anhedonia that are common across several neuropsychiatric disorders.”
Presentation Details and Summary
The following posters were presented on Saturday, October 10, 2026 at 12:00-1:25 pm CEST:
Title: LB-102 effect on dopamine D2 autoreceptors: Results from a preclinical study evaluating dopamine efflux in rat nucleus accumbens using microdialysis
Poster Number: PS01-1019
The poster highlights preclinical data demonstrating that LB-102 can modulate dopamine signaling through engagement of pre-synaptic D2 autoreceptors whose normal function is to constrain dopamine release in a key brain region implicated in schizophrenia, mood disorders and other neuropsychiatric disorders. By attenuating autoreceptor-mediated inhibition of dopamine release, LB-102 increased dopamine neurotransmission. These results support a potential mechanism through which LB-102 may address the hypodopaminergic state associated with anhedonia and diminished motivation in depression. These findings support the scientific rationale for LB-102’s potential for clinical activity in mood disorders and highlight its potential to address symptoms such as anhedonia that is common across neuropsychiatric disorders.
Title: Effects of LB-102 on cognitive performance in patients with schizophrenia: Post hoc analyses from the phase 2 randomised NOVA-1 trial.
Poster Number: PS01-1156.
This encore poster presentation highlights the dose-dependent, statistically significant improvements in cognitive performance observed in the Phase 2 NOVA-1 trial in schizophrenia as measured by the Global Cognition composite score as well as a post hoc analysis that was designed to assess whether the observed improvement in cognitive performance was a direct effect of LB-102 or an indirect consequence of the effect of LB-102 on total schizophrenia symptoms. Results of the analysis demonstrated that the cognitive benefit was primarily a direct effect of LB-102.
Title: Phase 3 clinical development program of LB-102 in schizophrenia: A double-blind placebo-controlled trial (NOVA-2) and an open-label extension study (NOVA-3)
Poster Number: PS01-1226
The poster describes the ongoing, pivotal Phase 3 trial (NOVA-2) and open label extension trial (NOVA-3) designed to evaluate the efficacy, safety and long-term effectiveness of LB-102 as a once-daily treatment for adults with schizophrenia.
The following e-Poster is presented as an e-poster through the conference platform:
Title: LB-102 in patients with bipolar I disorder experiencing a major depressive episode: Phase 2, double-blind, placebo-controlled trial design (ILLUMINATE-1)
Poster Number: EP01-1056
The poster features the design of the ongoing, potentially registrational Phase 2 ILLUMINATE-1 trial evaluating the efficacy and safety of once-daily LB-102 monotherapy in adults with bipolar depression, as well its effects on cognition, anhedonia, and the incidence of treatment-emergent mania.
LB Pharmaceuticals presentations are available on the Publication page on LB Pharmaceuticals website at https://lbpharma.us.
About LB Pharmaceuticals
LB Pharmaceuticals is a neuromedicines company dedicated to developing and commercializing high-impact therapies that address the multiple dimensions of underserved brain disorders. 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 opportunity 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 balanced clinical activity and tolerability profile that provides a potentially attractive alternative to branded and generic therapeutics for the treatment of a broad range of neuropsychiatric diseases.
About LB-102
LB-102 is a novel, once-daily, orally administered investigational small molecule being developed for multiple neuropsychiatric disorders. It is a new chemical entity that has been structurally engineered with a modification to amisulpride, a widely used antipsychotic outside the United States, and has the potential to be the first benzamide antipsychotic in the United States for the treatment of neuropsychiatric disorders. LB-102 was developed with the aim of retaining amisulpride’s benefits while addressing its limitations. LB-102 is a potent and selective antagonist of D2, D3, and 5-HT7 receptors with few off-target effects and which may have broad therapeutic potential across psychosis and mood disorders. In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia. In this trial, LB-102 demonstrated statistically significant benefit versus placebo at all doses studied, including rapid onset of effect at week 1 and sustained benefit through the endpoint of the trial, a potentially class-leading safety profile with low rates of EPS (including akathisia), minimal sedation and few GI side effects, alongside effects on negative symptoms and cognitive performance. These data underscore LB-102’s potential to address multiple dimensions of neuropsychiatric illness. The pivotal Phase 3 NOVA-2 trial of LB-102 for acute schizophrenia and the Phase 2 ILLUMINATE-1 trial of LB-102 for bipolar 1 depression are ongoing, and a Phase 2 trial of LB-102 in adjunctive treatment of MDD is planned. The Company is also pursuing additional expansion opportunities for LB-102 including predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as 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 unique mechanism of LB-102, the potential therapeutic benefits of LB-102, and the design, objectives, initiation, timing, progress and expected results of clinical trials of LB-102. 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 section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 and its other documents to be subsequently filed with or furnished to the Securities and Exchange Commission. 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.
Media and Investor Contact:
Ellen Rose
erose@lbpharma.us
