LB Pharmaceuticals Presents New Analysis from the Phase 2 NOVA-1 Trial Highlighting LB-102's Potential Impact on Cognitive Performance at the 2026 Annual Congress of the Schizophrenia International Research Society (SIRS)
NEW YORK, March 27, 2026 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc ("LB Pharmaceuticals" or the "Company") (NASDAQ:LBRX), a late-stage biopharmaceutical company developing novel therapies for schizophrenia, bipolar depression, adjunctive treatment of major depressive disorder (MDD), and other neuropsychiatric diseases, today announced the presentation of new data further evaluating the effects of LB-102 on cognitive performance in the Phase 2 NOVA-1 clinical trial in patients with acute schizophrenia. LB-102, a novel, once-daily, oral investigational small molecule, is a selective antagonist of D2, D3, and 5HT7 receptors that is being advanced as a potential first benzamide antipsychotic in the U.S. for the treatment of neuropsychiatric disorders. The post hoc analysis was designed to assess whether the improvement in cognitive performance, as measured by the Global Cognition composite score, 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, and statistically significantly, a direct effect of LB‑102. The presentation, titled "LB-102 for Cognition in Patients with Schizophrenia: An Exploratory Post Hoc Analysis from a Randomized, Double-blind, Placebo-controlled Phase 2 Study" was highlighted at the Schizophrenia International Research Society (SIRS) meeting on March 27th in Florence, Italy.
"There remains significant unmet need for new schizophrenia therapies that offer patients the potential for improvements in cognitive symptoms that drive functional impairment," said Anna Eramo, M.D., Chief Medical Officer of LB Pharmaceuticals. "This new analysis provides additional insights into the potential of LB-102 to offer differentiated improvement in cognitive performance that is independent of its effect on overall schizophrenia symptoms. Based on these robust data, we are prospectively evaluating cognitive performance as a secondary endpoint in our recently initiated pivotal Phase 3 trial (NOVA-2) of LB-102 in patients with acute schizophrenia, our planned open label extension trial in patients with schizophrenia, as well as our ongoing and planned trials in bipolar 1 depression and adjunctive MDD."
In addition, an encore oral presentation titled "LB-102 for Acute Schizophrenia in Adults: Results from the Phase 2 NOVA-1 Clinical Trial, with a Focus on PANSS Marder Factor Scores" was also presented at SIRS. This presentation reviewed an analysis exploring LB-102's effect on PANSS Marder factor, which provides a more nuanced framework for understanding the complexities of schizophrenia symptoms. This analysis evaluated LB‑102's effects across the five PANSS Marder factors: Positive Symptoms, Negative Symptoms, Disorganized Thought, Hostility/Excitability, and Anxiety/Depression.
In the Phase 2 NOVA-1 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. LB-102 was generally safe and well tolerated, exhibiting a potentially class-leading safety profile with low rates of extrapyramidal symptoms (EPS) (including akathisia), minimal sedation and few gastrointestinal (GI) side effects alongside effects on negative symptoms and cognitive performance. A dose dependent, and statistically significant improvement in the global cognition composite score was observed at all dose levels in a patient population that was not enriched for severe cognitive impairment at baseline.
In addition to the oral and poster presentation, the Company sponsored a Satellite Symposium titled "Next-Generation Perspectives in Schizophrenia: Translating Emerging Science Into Practice" featuring John Kane, M.D., Professor, Psychiatry and Molecular Medicine at the Donald and Barbara Zucker School of Medicine and Christoph Correll, M.D., Professor of Child and Adolescent Psychiatry at the Charité-Universitätsmedizin Berlin and Donald and Barbara Zucker School of Medicine.
The poster and oral presentations are available on the LB Pharma Publication page on LB Pharmaceuticals website at https://lbpharma.us/.
About LB-102
LB-102 is a novel, once-daily, orally administered investigational small molecule and potential first benzamide antipsychotic in the U.S. for the treatment of neuropsychiatric disorders. A methylated derivative of amisulpride, a widely used antipsychotic outside the U.S., LB-102 was developed to retain amisulpride's benefits while addressing its limitations. LB-102 is a potent and selective antagonist of D2, D3, and 5HT-7 receptors with few off-target effects and 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. A Phase 3 clinical trial (NOVA-2) of LB-102 for schizophrenia and a Phase 2 clinical trial (ILLUMINATE-1) of LB-102 for bipolar depression have been initiated, and a Phase 2 trial in adjunctive treatment of MDD is planned. Additional expansion opportunities for LB-102 include predominantly negative symptoms of schizophrenia, Alzheimer's disease psychosis and agitation, as well as other neuropsychiatric diseases.
About LB Pharmaceuticals
LB Pharmaceuticals is a late-stage biopharmaceutical company developing novel therapies for the treatment of schizophrenia, bipolar depression, adjunctive treatment of major depressive disorder 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 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.
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 therapeutic benefits of LB-102; and the design, objectives, initiation, timing, progress and results of current and future clinical trials of LB-102, including the Phase 2 NOVA-1 trial and the Phase 3 NOVA-2 trial. 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 Annual Report on Form 10-K for the year ended December 31, 2025 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.
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