Amisulpride

Topline data expected in 1Q 2028 Phase 2 bipolar depression trial initiation follows positive Phase 2 results in acute schizophrenia NEW YORK, Jan. 26, 2026 (GLOBE NEWSWIRE) -- LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX), a clinical-stage biopharmaceutical company developing novel therapies for schizophrenia, bipolar depression, and other neuropsychiatric diseases, today announced the initiation of a Phase 2 trial evaluating the efficacy and safety of LB-102 in patients with bipolar depression. LB-102, a novel, once-daily, oral investigational small molecule, is a potent and 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. “Our year is off to a strong start and the initiation of this Phase 2 trial in patients with bipolar depression marks an important step in our strategy to expand the potential of LB-102 for the treatment of mood disorders,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “We believe the compelling results from our Phase 2 trial in acute schizophrenia, the heritage of clinical and real-word experience with amisulpride in the treatment of mood disorders, and our innovative fixed-flexible dose trial design can significantly derisk this program. We look forward to a number of late-stage clinical catalysts, including results from this Phase 2 trial in the first quarter of 2028, as well as from our planned Phase 3 trial in schizophrenia which remains on track to initiate this quarter with results expected in the second half of 2027.” Anna Eramo, Chief Medical Officer of LB Pharmaceuticals added, “We believe LB-102’s pharmacologic profile, including selective D2, D3, and 5HT7 receptor antagonism and favorable tolerability observed in prior clinical trials, aligns well with the critical unmet needs in bipolar depression. Significant opportunity exists for new therapies that can offer early onset of effect, reduced side effects such as sedation and EPS (including akathisia), and improvement in anhedonia and cognitive deficits, all of which can impact a patient’s ability to function.” Phase 2 Bipolar Depression ILLUMINATE-1 Trial Design The Phase 2 trial is a multi-center, randomized, double-blind, placebo-controlled trial with fixed- and flexible-doses and is designed to evaluate the efficacy and safety of two doses (25 mg and 50 mg given once daily) of LB-102 for the treatment of bipolar depression. The two-arm, six-week, outpatient trial is expected to enroll approximately 320 patients with bipolar 1 depression at approximately 30 sites in the U.S. Patients will be randomized 1:1 to receive either LB-102 or placebo. The primary endpoint is the Montgomery–Åsberg Depression Rating Scale (MADRS)-10 at week six. The primary statistical analysis will compare results from all patients receiving LB-102, regardless of dose, with placebo. Secondary endpoints include MADRS-6, and CGI-BP, cognition, and anhedonia, as well as safety and tolerability. Topline results from the trial are anticipated in the first quarter of 2028. 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 antipsychotics 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 5HT7 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 and sustained benefit, a potentially class-leading safety profile with low rates of EPS (including akathisia), minimal sedation and few GI side effects, alongside robust effects on cognition and negative symptoms. These data underscore LB‑102’s potential to address multiple dimensions of neuropsychiatric illness. LB-102 is advancing into a Phase 3 clinical trial for schizophrenia and a Phase 2 clinical trial for bipolar depression has been initiated. Additional expansion opportunities for LB-102 include major depressive disorder, predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as other neuropsychiatric diseases. About Bipolar Depression Bipolar disorder is a chronic, debilitating mood disorder in which patients alternate between manic and depressive states. There are approximately 7 million patients in the U.S. and 40 million patients worldwide suffering from bipolar disorder. Antipsychotic medications, with or without mood stabilizers, are a mainstay of therapy for bipolar depression due to their ability to control depressive symptoms while preventing the emergence of mania. Despite the availability of several branded and generic therapeutics, significant unmet needs remain including faster onset without dose titration, lower rates of adverse events (including extrapyramidal symptoms, sedation, and GI side effects), efficacy against residual symptoms (including anhedonia and cognitive deficits), as well as improved medication adherence. Approximately 60% of patients with bipolar depression experience cognitive impairment and loss of interest/enjoyment (anhedonia) despite treatment, as well as high rates of adverse events, which together contribute to high rates of medication discontinuation and increased risk of relapse. 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 balanced clinical activity and tolerability profile that provides 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 timing of clinical data readouts for the Company’s Phase 2 ILLUMINATE-1 trial in bipolar depression and Phase 3 trial in acute schizophrenia, planned trial design of the Phase 2 ILLUMINATE-1 trial, clinical development and regulatory pathway and therapeutic benefits of LB-102 and 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 section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 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. Media and Investor Contact: Ellen Roseerose@lbpharma.us