Amisulpride

Pivotal Phase 3 NOVA-2 trial in schizophrenia ongoing, topline data expected in 2H 2027 LB-102 has potential to be the first benzamide approved for schizophrenia in the U.S. NEW YORK, April 22, 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 major depressive disorder (MDD), and other neuropsychiatric diseases, today announced the publication in the Journal of the American Medical Association (JAMA) Psychiatry of its manuscript titled “Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults with Acute Schizophrenia: A Phase 2 Randomized Clinical Trial.” LB-102, a novel, once-daily, oral investigational small molecule, is a selective antagonist of D2, D3, and 5HT-7 receptors that is being advanced as a potential first benzamide in the U.S. for the treatment of neuropsychiatric disorders. “We are pleased to publish the positive results from the Phase 2 NOVA-1 trial in this prestigious, peer-reviewed journal, which we believe underscores the potential for LB-102, if approved, to become an important new treatment option for patients with schizophrenia,” commented Anna Eramo, MD, Chief Medical Officer of LB Pharmaceuticals. “Based on LB-102’s unique mechanism and these compelling clinical results, we have advanced LB-102 into the pivotal Phase 3 NOVA-2 trial for patients with schizophrenia the Phase 2 ILLUMINATE-1 trial of LB-102 in bipolar depression and plan to initiate a Phase 2 trial in adjunctive MDD in early 2027.” The positive data from the NOVA-1 trial were first announced in early 2025. In this four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia, 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 pro 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 domains of neuropsychiatric disease. LB-102 is currently being evaluated in the pivotal Phase 3 NOVA-2 trial in patients with acute schizophrenia. NOVA-2 is a double-blind placebo-controlled trial that is 6 weeks in duration and designed to enroll approximately 460 patients across 25 sites in the United States. Topline results from NOVA-2 are anticipated in the second half of 2027 and if positive, the Company expects to hold a pre-NDA meeting with FDA thereafter. 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 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 pro 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 domains of neuropsychiatric disease. 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, the adjunctive treatment of MDD, 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 pro provides a potentially attractive alternative to branded and generic therapeutics for the treatment of schizophrenia, bipolar depression, adjunctive MDD, 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 regulatory pathway and 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, the Phase 3 NOVA-2 trial and the Phase 2 ILLUMINATE-1 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. Media and Investor Contact : Ellen Rose erose@lbpharma.us

2026精神分裂症治疗重磅突破：新药、新方案与全病程福音来袭 精神分裂症作为慢性、高复发的严重精神障碍，全球患者约2400万，我国近800万，5年内复发率超80%，长期受阳性症状（幻觉/妄想）、阴性症状（情感淡漠/社交退缩）及认知障碍困扰，且传统药物易引发体重增加、高泌乳素、心律失常等副作用，治疗依从性与预后长期受限。而2026年，我国在药物研发、治疗方案、服务体系上迎来多重历史性突破，为患者带来全新希望。 一、全新机制新药获批，70余年突破核心困境 全球70余年首个全新作用机制抗精神分裂症药物凯捷乐®（呫诺美林曲司氯铵胶囊） 于2025年12月获我国NMPA批准，2026年正式落地，彻底打破传统治疗局限。 - 核心创新：靶向M1/M4毒蕈碱受体，而非传统多巴胺/5-羟色胺通路，通过“中枢精准激活、外周协同保护”设计，兼顾疗效与安全性。 - 临床优势：同时改善阳性、阴性症状及认知功能，Ⅲ期数据显示PANSS总分较基线降低9.2分，显著优于安慰剂；无体重增加、高泌乳素、锥体外系反应等副作用，初期仅偶发一过性消化道反应。 - 指南地位：被《中国精神分裂症防治指南（2025版）》全球首次纳入国家级指南，2024年获美国FDA批准，2025年提名盖伦奖最佳药品奖，全球学界高度认可。 二、国产剂型升级，用药便捷性与依从性双提升 2026年3月，科伦药业两款新药同步获批，丰富治疗选择，解决长期漏服、依从性差的痛点。 1. 注射用阿立哌唑（怡悦安®）：采用微球技术，每月注射一次长效制剂，从根源杜绝漏服，为维持期治疗提供稳定保障，已纳入临床指南与医保。 2. 布瑞哌唑口溶膜（哌立安®）：口溶膜剂型无需用水，适合吞咽困难或居家/外出场景，提升用药便捷性，尤其适配老年或青少年患者。 此外，日本住友制药布南色林片处于审批待制证阶段，该药对阳性、阴性症状改善效果显著，且血泌乳素升高、心脏相关不良事件发生率低于已上市药品，即将为患者提供更多安全选择。 三、治疗方案优化，早期干预与难治病例迎来新突破 1. 序贯治疗新证据：2026年3月，上海精神卫生中心牵头的多中心临床试验（SMART-CAT）发表于《JAMA Psychiatry》，证实首次治疗失败后尽早使用氯氮平，有效率达62.5%，显著优于奥氮平（31.7%）与氨磺必利（44.7%），打破“仅难治病例后期使用”的传统认知，缩短治疗试错期。 2. 本土物理治疗入选指南：湘雅原创物理治疗技术写入《中国精神分裂症防治指南（2025版）**，连续10天刺激左背外侧额上回，可显著提升信息处理、语言与推理能力，疗效持续1个月以上，实现本土技术从跟跑到领跑的跨越。 四、服务体系扩容，全病程管理更可及 国家层面同步推进精神卫生服务能力建设，2026年将新增110个县提供心理门诊服务，推动精神卫生服务下沉基层，实现“小病在基层、大病转上级、康复回社区”的全病程管理格局。基层医院配备全科医生、常用药与基础检查，医保报销比例较三甲高10%-15%，降低患者就医成本；同时完善长效药物医保覆盖、规范血液监测体系，让创新治疗真正惠及每一位患者。 五、前沿研究进展，未来治愈希望持续扩容 1. 遗传机制突破：2026年1月，中科院团队在《Science Advances》发表研究，首次锁定精神分裂症遗传风险的全新“剪接开关”，阐明疾病因果链条，为精准靶向治疗奠定基础。 2. 干细胞治疗探索：基于诱导多能干细胞（iPSC）的神经修复临床试验稳步推进，通过分化补充受损神经元、重建神经环路，为难治性病例提供潜在治疗方向，目前已进入严格临床验证阶段。 六、患者与家属行动指南：抓住治疗黄金期 1. 及时就医：出现幻觉、妄想、社交退缩等症状，立即前往精神专科门诊，避免延误治疗。 2. 规范用药：优先咨询医生，根据症状类型、体质及依从性需求，选择凯捷乐®、国产长效针剂或口溶膜等合适药物，切勿自行停药。 3. 全病程管理：配合基层随访、康复训练，定期复查血常规、代谢指标，同时获得家庭与社会支持，提升治疗依从性。 结语 2026年，精神分裂症治疗迎来“新药+新方案+新体系”三重升级，从症状控制到全病程管理，从疗效优先到兼顾安全与便捷，切实破解长期临床痛点。随着创新药物可及性提升、服务体系完善，患者有望更稳定地控制症状、保留社会功能，逐步回归正常生活。