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声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。 2024年的最后一个季度将有多款候选药物的临床数据揭晓，针对适应症包括肥胖症、抑郁症、阿尔茨海默症、疼痛管理、肌萎缩症、精神分裂症和多发性硬化症。药物模态则涵盖小分子、单抗、蛋白、CAR-T、多肽，以及一种非常特殊的抗体-多肽偶联物。 安进Peptibody减肥药MariTIDE 在百舸争流的肥胖症开发领域中，安进的候选药MariTide（Maridebart Cafraglutide）非常显眼。这是因为它非常特殊的抗体-多肽偶联物（也称作Peptibody）和别具一格的作用机制。MariTide分子是将两个GLP-1受体激动剂多肽偶联到一个抗GIP（Glucose-dependent Insulinotropic Peptide，葡萄糖依赖性促胰岛素多肽，亦称“抑胃肽”）抗体之上，组成一个三部分缀合的抗体多肽偶联物。其中GLP-1受体激动剂负责激活GLP-1受体，刺激胰岛素分泌，而抗GIP抗体负责下调GIP的分泌，两股力量协同在一起，实现可控的减肥目标（图1）。 图1. MariTide分子结构以及作用机理示意图。（图片来源：Amgen） MariTide将在今年年底之前公布II期临床结果，在比较和评估3 种选定剂量的MariTide与安慰剂相比在第52 周诱导和维持体重减轻的效果，对象包括超重或肥胖但不患有糖尿病的参与者（队列A）和超重或肥胖且患有2 型糖尿病的参与者（队列B）。整个行业对此项研究结果高度关注。 诺和诺德新重磅减肥药CagriSema 诺和诺德将在今年年底前公布其减肥候选药物CagriSema 的III期研究结果。CagriSema是 GLP-1药物Semaglutide（即Ozempic和 Wegovy中的活性成分）和cagrilintide（胰淀素类似物）的组合。今年即将公布的III期研究是2.4 mg Semaglutide和2.4 mg cagrilintide剂量的疗法结果。除此之外，诺和诺德还在今年夏天开始了一项新的CagriSema III期试验，测试降低的剂量，即1.0 mg segmaglutide/1.0 mg cagrilintide和1.7 mg semaglutide/1.7 mg cagrilintide的减肥效果，给药频率为每周两次。新III期研究的结果估计将于2026年公布。 艾伯维精神分裂症药物emraclidine 百时美施贵宝的Cobenfy今年九月份成为了首个获得FDA批准的靶向大脑毒蕈碱受体的精神分裂症药物。与此同时，艾伯维正在积极开发一种同类型的竞争药物，名为emraclidine。该候选药是艾伯维去年87亿美元 收购Cerevel Therapeutics带来的，目前正在对精神分裂症和阿尔茨海默病精神病进行测试。同刚刚获批的Cobenfy一样，emraclidine也是选择性M4毒蕈碱受体正变构调节剂。与主要针对多巴胺受体拮抗作用的传统抗精神病药物不同，emraclidine调节毒蕈碱通路，可能提供抗精神病作用且副作用更少。其精神分裂症关键临床试验结果将在今年年底前完成。 脊髓性肌萎缩症单抗候选药apitegromab Scholar Rock 正在开发一种名为apitegromab的单抗药物，阻断肌生长抑制素（myostatin）的前体蛋白形式，肌生长抑制素是一种阻碍肌肉生长的蛋白质，限制骨骼肌细胞的增殖和分化，以防止肌肉过度生长。Apitegromab主要适应症是脊髓性肌萎缩症（SMA, spinal muscular atrophy）。Apitegromab的一项3 期安慰剂对照研究评估apitegromab 对2型和 3 型 无法独立行走的SMA患者的效果，该研究将于本季度公布结果。 脊髓性肌萎缩症 (SMA)是一种影响运动神经元（控制随意肌运动的神经细胞）的疾病。这些细胞位于脊髓中。由于肌肉无法对来自神经的信号作出反应，它们会因不活动而萎缩（变弱和萎缩）。每6000 名婴儿中就有一名患有SMA。它是影响幼儿的最普遍的遗传性疾病之一，也是婴儿死亡的主要原因。 Biohaven脊髓性肌萎缩症药物BHV-2000 Biohaven Pharmaceuticals 也在开发一种肌生长抑制素阻断药物taldefgrobep alfa（又名BHV-2000）。Taldefgrobep alfa (BHV-2000) 是一种完全人类重组蛋白，专门用于抑制肌生长抑制素和激活素A 的信号传导，这两种物质都是肌肉和脂肪组织的关键调节剂。Taldefgrobep可与肌生长抑制素结合，并充当激活素2b 受体拮抗剂。Taldefgrobep的新型作用机制有可能显著减少脂肪量、增加瘦肉量并改善多种代谢参数。Taldefgrobep alfa的III期结果将于年底前公布。 Vertex非阿片类止痛药期待突破 Vertex Pharmaceuticals 的下一个重大增长点可能是非阿片类止痛药suzetrigine（又名VX-548）。FDA正在审查suzetrigine用于急性疼痛的疗效，预计将于明年1 月 30日做出决定。在此之前，Vertex将在 12月公布一项针对慢性疼痛的II期研究结果，该研究针对腰骶神经根病（俗称坐骨神经痛）。 止痛药领域是相当多非阿片类药物的滑铁卢，suzetrigine如今有可能扭转这种局面。Suzetrigine的最大机遇可能在慢性疼痛，阿片类药物的效果较差，且风险较大。Vertex表示，suzetrigine的研究取得了明显的成功，它的安全性和有效性使其既可用于治疗手术性急性疼痛，也可用于治疗非手术性急性疼痛。市场分析师认为，如果获得批准，suzetrigine可能会成为一剂重磅炸弹，普遍估计到2030 年销售额可能达到15亿美元。但人们普遍认为，慢性疼痛市场更大，仅下背部疼痛就是全球致残的主要原因。鉴于过去的证据表明阿片类药物在这种情况下效果较差，并且伴有便秘、嗜睡、心率减慢和呼吸减慢等风险，suzetrigine将在这一领域超于阿片类止痛片。 ALTO重度抑郁症口服药II期读数 Cobenfy的批准为精神疾病领域的药物开发带来了新气象。Alto Neuroscience的口服重度抑郁症(MDD) 候选药ALTO-100的安慰剂对照IIb研究也将迎来关键读数。 ALTO-100，以前称为NSI-189 (最初由NeuralStem开发)是一种海马体神经发生刺激剂和间接脑源性神经营养因子(BDNF) 调节剂，目前正在开发用于治疗重度抑郁症、双相抑郁症和创伤后应激障碍(PTSD)，还可能用于治疗认知障碍和神经退行性疾病感兴趣。。ALTO-100是2021年Alto Neuroscience以490万美元的价格从NeuralStem合并后的公司Palisade Bio购买的资产。 阿尔茨海默病新机制单抗药物AL002 II期结果即将出炉 Alector 的阿尔茨海默病候选药AL002即将揭晓安慰剂对照的II期研究结果。AL002是Alector与艾伯维联合开发的。AL002是一种人源化单克隆IgG1 抗体，靶向髓系细胞2 上表达的触发受体(TREM2)，这是散发性阿尔茨海默病的重要遗传风险因素。TREM2是一种跨膜受体，在先天免疫细胞亚群上表达，并选择性地在构成大脑免疫系统的小胶质细胞上表达。TREM2功能降低可能导致阿尔茨海默病和其他形式的痴呆症。AL002通过激活 TREM2信号传导来抵消这种功能下降，从而提高细胞存活率和增殖率以及小胶质细胞活性，并减缓痴呆症的进展。小胶质细胞（microglia）是中枢神经系统中的主要免疫细胞，类似于外周免疫系统中的巨噬细胞。它们在大脑和脊髓中发挥着多种重要的免疫和支持功能。 Cassava争议药物III期结果即将问世 最近令Cassava Sciences陷入丑闻漩涡的阿尔茨海默病候选药simufilam的一项III期研究也将于今年12月完成。 Cassava Sciences两位前高管日前因涉及Simufilam的误导性声明，遭到了美国证券交易委员会（SEC）的指控。SEC指控Cassava前CEO Remi Barbier和前神经科学高级副总裁Lindsay Burns在2020年9月有关Simufilam的中期试验中作出多项误导性声明。他们删减了临床试验中40%受试者的数据，从而使得药物的效果看起来更好。公司和高管发布了关于2期试验的误导性结果，声称Simufilam对改善阿尔茨海默症患者的认知功能有效，实际上，完整数据表明药物并未改善患者的“情景记忆”。对此，Cassava同意支付4000万美元民事罚款，而Barbier和Burns分别支付17.5万和8.5万美元罚款，并接受董事和高管职位的禁令。与其合作的City University of New York教授Hoau-Yan Wang支付5万美元罚款。 该事件进一步加剧了要求暂停Simufilam晚期试验的呼声。专家们质疑该药物的疗效，并发现相关研究存在数据操纵的证据。在这种情况下，simufilam于12月完成的一项III期试验就格外令人关注。 多发性骨髓瘤CAR-T疗法anito-cel ArCellx 与吉利德共同开发的靶向BMCA的CAR-T疗法anito-cel，针对多发性骨髓瘤，将于11 月初在美国血液学会年会公布其II期临床iMMagine-1结果。Anito-cel已获得FDA的快速通道、孤儿药和再生医学先进疗法称号。去年，FDA在一名参与者死亡后部分暂停了iMMagine-1试验，但几个月后，试验修改被解除，旨在预防和管理不良事件的风险。如果anito-cel能够在多发性骨髓瘤领域获得最终的成功，它将对BMS的CAR-T疗法Abecma发起挑战。 Ref. Karlsson, C. D. Novo Nordisk initiates new phase 3 trial with Wegovy successor. Med Watch. 18. 09. 2024. Incorvaia, D. AbbVie's dopamine-focused Parkinson's treatment reduces disease burden in phase 3 trial. Fierce Biotech. 26. 09. 2024. Wosen, J. Vertex pain drug results met with measured optimism — and questions — by observers and experts. STAT. 30. 01. 2023. Alector Announces Completion of Enrollment in the INVOKE-2 Phase 2 Clinical Trial of AL002, a TREM2 Monoclonal Antibody, in Individuals With Early Alzheimer’s Disease. Alector Press Release. 07. 09. 2023. Piller, C. Company misled investors on possible Alzheimer’s drug, SEC charges. Science. 30. 09. 2024. Wexler, M. CAR T-cell therapy anito-cel set for Phase 3 trial in multiple myeloma. Myeloma Research News. 14. 05. 2024. Feuerstein, A. The biotech scorecard for the fourth quarter: 14 stock-moving events to watch. STAT. 02. 10. 2024. -END- 药事纵横投稿须知：稿费已上调，欢迎投稿 各位朋友好，觉得本文对您有帮助，请随手点一下下方的在看，以便让你的朋友也能看到哦。

PALO ALTO, Calif., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that it has received the Drug Distributor Accreditation from the National Association of Boards of Pharmacy® (NABP®). Scilex has satisfied all the drug distributor criteria set in place by the NABP. The NABP® is a 501(c)(3) nonprofit organization founded in 1904. Working with their members – the state boards of pharmacy – they help support patient and prescription drug safety, through examinations that assess pharmacist competency, pharmacist licensure transfer and verification services, and various pharmacy accreditation programs. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Semnur Pharmaceuticals, refer to www.semnurpharma.com For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022. Scilex Holding Company is headquartered in Palo Alto, California. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s long-term objectives and commercialization plans, future opportunities for Scilex, Scilex’s future business strategies and Scilex’s current and prospective product candidates. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with the unpredictability of trading markets; general economic, political and business conditions; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to Scilex Holding Company to use the registered trademark. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2024 Scilex Holding Company All Rights Reserved.

PALO ALTO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that Jaisim Shah, Chief Executive Officer and President of Scilex will present at the 26th Annual H.C. Wainwright Global Investment Conference taking place September 9-11, 2024 in New York City. Details on the presentation: H.C. Wainwright 26th Annual Global Investment Conference Location: Lotte NY Palace Hotel, New York CityDate: September 11, 2024Time: 8-8:30am ET For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXATM” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022. Scilex Holding Company is headquartered in Palo Alto, California. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s long-term objectives and commercialization plans, future opportunities for Scilex, Scilex’s future business strategies and Scilex’s current and prospective product candidates. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with the unpredictability of trading markets; general economic, political and business conditions; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to Scilex Holding Company to use the registered trademark. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2024 Scilex Holding Company All Rights Reserved.