A Two-Part Study Investigating the Relative Bioavailability and the Potential Food Effect After a Single Oral Dose Administration of a New Formulation of SYT-510, and the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Oral Dose Administration of SYT-510 in Healthy Subjects

Part 1 aims to investigate the relative bioavailability of a new formulation and to assess potential food effects following oral administration of SYT-510. Part 1 will then guide dosing in Part 2, a multiple dose study which aims to assess safety, tolerability and pharmacokinetic of multiple SYT-510 administrations.

开始日期2024-10-30

申办/合作机构

Synendos Therapeutics AG

100 项与 SYT-510 相关的临床结果

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100 项与 SYT-510 相关的转化医学

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100 项与 SYT-510 相关的专利（医药）

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项与 SYT-510 相关的新闻（医药）

2025-09-29

·药明康德

一针起效，应答率达100%的多肽疫苗；使关键靶蛋白降解率超80%的口服小分子疗法…… | 一周盘点

本期看点 1. 用于治疗阿尔茨海默病的多肽疫苗ACI-35.030的1b/2a期临床试验结果积极，仅需1次注射即可让所有受试者产生抗磷酸化Tau（pTau）IgG抗体滴度，2周时所有剂量组的应答率达100%。 2. 口服小分子IKZF1/3蛋白降解剂cemsidomide联合地塞米松治疗复发/难治性多发性骨髓瘤（RRMM）的1期临床试验数据积极，最高剂量组的总缓解率（ORR）达50%，关键靶蛋白IKZF1的降解率＞50%，IKZF3降解率＞80%。 ACI-35.030（JNJ-2056）：公布1b/2a期临床试验数据 AC Immune公司公布了其用于治疗阿尔茨海默病的免疫疗法ACI-35.030的1b/2a期临床试验结果。ACI-35.030基于AC Immune的SupraAntigen技术平台开发，该技术将pTau肽锚定在脂质体中，同时包含非Tau T细胞表位和佐剂。试验还研究了另一种免疫疗法JACI-35.054，两种疗法针对同一靶点。临床数据显示，针对同一靶点的两种不同主动免疫疗法制剂，能在早期阿尔茨海默病患者体内诱导产生有差异的抗体反应。安全性方面，ACI-35.030和JACI-35.054均未报告任何具有临床意义的安全性或耐受性问题。ACI-35.030仅需一次注射即可使所有受试者产生抗pTau IgG抗体滴度，并在后续接种中持续提升抗体水平。在接受ACI-35.030治疗后2周时，所有剂量组的所有受试者均被认定为抗pTau IgG应答者。在两个高剂量组中，应答率在第74周时仍维持在94%至100%之间。目前，ACI-35.030已被选中推进至关键性2b期ReTain临床试验，用于治疗临床前期阶段的阿尔茨海默病。 Cemsidomide：公布1期临床试验数据 C4 Therapeutics公司公布了其在研口服小分子IKZF1/3蛋白降解剂cemsidomide联合地塞米松治疗复发/难治性多发性骨髓瘤的1期临床试验数据。截至2025年7月23日的数据，在接受过多线治疗的RRMM患者中，cemsidomide联合地塞米松展现出强劲且持久的抗肿瘤活性。最高剂量组（100 µg）患者的ORR达50%；75 µg剂量组的ORR为40%。所有剂量组的中位缓解持续时间（DOR）为9.3个月，在两个最高剂量组中，中位缓解持续时间尚未达到。药效学（PD）结果显示，cemsidomide与地塞米松联用可高效降解靶蛋白并激活T细胞，在人外周血单核细胞中，IKZF1的降解率＞50%、IKZF3降解率＞80%，且在所有剂量下均显著增强T细胞活化和IL-2等细胞因子的产生，展现出与地塞米松联用或与地塞米松+BCMA双特异性T细胞衔接器（BCMA BiTE）联用的潜力。安全性方面，没有与cemsidomide相关的停药事件，且很少有剂量减少事件（6%），为其在联合治疗方案中的广泛应用提供了有力支持。 SYT-510：公布1期临床试验数据 Synendos Therapeutics公司公布了其核心候选药物SYT-510在健康受试者中开展的1期临床试验的积极结果。SYT-510靶向内源性大麻素系统（ECS）中一个新近发现的靶点，属于新型ECS调节剂——选择性内源性大麻素再摄取抑制剂（SERIs）类别。研究结果表明，SYT-510在所有剂量下均具有良好的耐受性，安全性良好。药代动力学（PK）数据显示，SYT-510能够穿透血脑屏障，在中枢神经系统（CNS）中达到有效浓度。该药物展现出明确的脑部药效学作用，其对脑电图（EEG）的影响与成功用于控制焦虑症状的抗焦虑药物一致。 MF-300：公布1期临床试验数据 Epirium Bio公司宣布，其潜在“first-in-class”的口服15-羟基前列腺素脱氢酶（15-PGDH）抑制剂MF-300，在针对肌肉减少症的1期临床试验中取得积极结果。5-PGDH是一种能将前列腺素E2（PGE2）转化为非活性代谢物的酶。MF-300旨在可逆地结合到15-PGDH的PGE2结合位点上，阻止该酶转化PGE2。在生化试验中，MF-300能够抑制15-PGDH的活性。在临床前的细胞和动物研究中，MF-300可稳定和增加PGE2的水平。此次试验达到了主要安全性终点，所有研究剂量的MF-300总体耐受性良好，且无受试者因不良反应而退出。MF-300呈现出剂量依赖性的PD应答，该应答出现较早并随时间的推移持续存在，而安慰剂组则未观察到显著变化，表明药物成功与靶点结合并具有生物学活性。PK分析显示，药物暴露量随剂量增加而上升，其半衰期支持每日一次口服给药方案。参考资料： [1] Intellia Therapeutics Announces Positive Longer-Term Phase 1 Data for Nexiguran Ziclumeran (nex-z) in Patients with Hereditary Transthyretin (ATTR) Amyloidosis with Polyneuropathy. Retrieved September 26, 2025, from https://www.globenewswire.com/news-release/2025/09/25/3156402/0/en/Intellia-Therapeutics-Announces-Positive-Longer-Term-Phase-1-Data-for-Nexiguran-Ziclumeran-nex-z-in-Patients-with-Hereditary-Transthyretin-ATTR-Amyloidosis-with-Polyneuropathy.html [2] Bambusa Therapeutics Announces Highly Positive Healthy Volunteer Results and First Atopic Dermatitis Patient Dosed in Phase I Trial of BBT001. Retrieved September 26, 2025, from https://www.prnewswire.com/news-releases/bambusa-therapeutics-announces-highly-positive-healthy-volunteer-results-and-first-atopic-dermatitis-patient-dosed-in-phase-i-trial-of-bbt001-302567230.html [3] Rallybio Completes Dosing of First Cohort in RLYB116 Phase 1 Confirmatory Pharmacokinetic/Pharmacodynamic Study. Retrieved September 26, 2025, from https://www.businesswire.com/news/home/20250924016253/en/Rallybio-Completes-Dosing-of-First-Cohort-in-RLYB116-Phase-1-Confirmatory-PharmacokineticPharmacodynamic-Study [4] uniQure Announces Positive Topline Results from Pivotal Phase I/II Study of AMT-130 in Patients with Huntington’s Disease. Retrieved September 26, 2025, from https://www.globenewswire.com/news-release/2025/09/24/3155348/0/en/uniQure-Announces-Positive-Topline-Results-from-Pivotal-Phase-I-II-Study-of-AMT-130-in-Patients-with-Huntington-s-Disease.html [5] Kyverna Therapeutics Highlights Potential of KYV-101 in Multiple Sclerosis with Data from Phase 1 Investigator-Initiated Trials to be Presented at ECTRIMS. Retrieved September 26, 2025, from https://www.globenewswire.com/news-release/2025/09/24/3155539/0/en/Kyverna-Therapeutics-Highlights-Potential-of-KYV-101-in-Multiple-Sclerosis-with-Data-from-Phase-1-Investigator-Initiated-Trials-to-be-Presented-at-ECTRIMS.html [6] Epirium Bio Announces Positive Phase 1 Clinical Trial Results Evaluating MF-300 in Healthy Volunteers, A First-In-Class, Oral 15-PGDH Enzyme Inhibitor, For the Treatment of Sarcopenia. Retrieved September 26, 2025, from https://www.businesswire.com/news/home/20250924461947/en/Epirium-Bio-Announces-Positive-Phase-1-Clinical-Trial-Results-Evaluating-MF-300-in-Healthy-Volunteers-A-First-In-Class-Oral-15-PGDH-Enzyme-Inhibitor-For-the-Treatment-of-Sarcopenia [7] Actio Biosciences Announces First Participant Dosed in Phase 1 Clinical Trial of ABS-1230, a KCNT1 Inhibitor for the Treatment of KCNT1-Related Epilepsy. Retrieved September 26, 2025, from https://actiobiosciences.com/actio-biosciences-announces-first-participant-dosed-in-phase-1-clinical-trial-of-abs-1230-a-kcnt1-inhibitor-for-the-treatment-of-kcnt1-related-epilepsy/ [8] CellProthera announces peer-reviewed publication of its Phase I/IIb results on safety and feasibility of ProtheraCytes® in patients with severe heart failure post-myocardial Infarction. Retrieved September 26, 2025, from https://www.cellprothera.com/en/cellprothera-announces-peer-reviewed-publication-of-its-phase-i-iib-results-on-safety-and-feasibility-of-protheracytes-in-patients-with-severe-heart-failure-post-myocardial-infarction/ [9] MIRA Pharmaceuticals Announces Favorable Topline Results from Phase 1 SAD Study of Oral Ketamir-2, a Next-Generation Non-Scheduled Ketamine Analog. Retrieved September 26, 2025, from https://mirapharmaceuticals.com/mira-pharmaceuticals-announces-favorable-topline-results-from-phase-1-sad-study-of-oral-ketamir-2-a-next-generation-non-scheduled-ketamine-analog/ [10] Ionis announces positive topline results from pivotal study of zilganersen in Alexander disease. Retrieved September 26, 2025, from https://secure.businesswire.com/news/home/20250922674696/en/Ionis-announces-positive-topline-results-from-pivotal-study-of-zilganersen-in-Alexander-disease [11] Skye Presents Phase 1b Data for its Peripheral CB1-inhibiting Antibody, Nimacimab, at European Association for the Study of Diabetes (EASD) Annual Meeting. Retrieved September 26, 2025, from https://www.globenewswire.com/news-release/2025/09/19/3153078/0/en/Skye-Presents-Phase-1b-Data-for-its-Peripheral-CB1-inhibiting-Antibody-Nimacimab-at-European-Association-for-the-Study-of-Diabetes-EASD-Annual-Meeting.html [12] C4 Therapeutics Presents Cemsidomide Phase 1 Multiple Myeloma Data Supporting Potential Best-in-Class Profile at the International Myeloma Society Annual Meeting. Retrieved September 26, 2025, from https://www.globenewswire.com/news-release/2025/09/20/3153507/0/en/C4-Therapeutics-Presents-Cemsidomide-Phase-1-Multiple-Myeloma-Data-Supporting-Potential-Best-in-Class-Profile-at-the-International-Myeloma-Society-Annual-Meeting.html [13] Synendos Therapeutics Reports Positive and Highly Promising Topline Results from Phase 1 Trials, Paving the Way for Phase 2 in Mental Health. Retrieved September 26, 2025, from https://www.globenewswire.com/news-release/2025/09/24/3155178/0/en/Synendos-Therapeutics-Reports-Positive-and-Highly-Promising-Topline-Results-from-Phase-1-Trials-Paving-the-Way-for-Phase-2-in-Mental-Health.html [14] Peer-reviewed results from Phase 1b/2a Trial of Anti-pTau Active Immunotherapy from AC Immune Published in eBioMedicine. Retrieved September 26, 2025, from https://www.globenewswire.com/news-release/2025/09/25/3156158/0/en/Peer-reviewed-results-from-Phase-1b-2a-Trial-of-Anti-pTau-Active-Immunotherapy-from-AC-Immune-Published-in-eBioMedicine.html 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果临床2期免疫疗法疫苗临床1期

2025-09-24

·GlobeNewswire-Health Care

Synendos Therapeutics Reports Positive and Highly Promising Topline Results from Phase 1 Trials, Paving the Way for Phase 2 in Mental Health

The studies established the lead asset to be well tolerated in healthy volunteers at all doses with a good safety profileSYT-510 demonstrated penetration in the central nervous system and a pharmacodynamic effect on the brain BASEL, Switzerland, Sept. 24, 2025 (GLOBE NEWSWIRE) -- Synendos Therapeutics (“Synendos”), the clinical-stage biotech company developing breakthrough therapies for neuropsychiatric disorders, announced today topline results for its lead asset, SYT-510, a first-in-class inhibitor that modulates a newly identified drug target in the Endocannabinoid System that helps restore healthy brain functions. Synendos successfully completed its Phase 1 clinical program in healthy volunteers, following the pre-clinical development of its lead compound SYT-510, and regulatory approval received from the EMA and MHRA. Initial key findings include: 60 healthy volunteers were dosed in the Single and Multiple Ascending Dose studies with no drug-related safety concerns.Plasma and central nervous system exposure reached the anticipated pharmacological levels for activity. The effect of SYT-510 on electroencephalograms (EEG), showed an effect on the brain consistent with that seen with anxiolytic medicines used successfully to control anxiety symptoms. Dr. Andrea Chicca, Co-Founder and CEO of Synendos Therapeutics, said, “SYT-510 is the first Selective Endocannabinoid Reuptake Inhibitors (SERIs) candidate that has advanced into humans and not only demonstrated an excellent safety and tolerability profile, but also promising pharmacokinetic properties and penetration into the central nervous system. Furthermore, the EEG data provide first evidence of an effect on the brain. Overall, this clinical result is very encouraging for our upcoming Phase 2 trial where we plan to demonstrate the validity of the first-in-class SERI mode of action in patients.” The completed pre-clinical and Phase 1 studies provide a strong foundation and rationale for advancing Synendos’ clinical program to evaluate the efficacy of SERI molecules across a spectrum of symptoms commonly observed in psychiatric and neurological disorders. “Our planned Phase 2 study in anxiety symptoms represents a critical step toward unlocking the therapeutic potential of SERIs across psychiatric and neurological disorders,” said Dr. George Garibaldi, CMO at Synendos. “By rigorously evaluating both symptom reduction and the restoration of daily function, our program is designed to generate clinically meaningful evidence and address what matters most to patients: the ability to regain their lives and achieve their full potential.” Through this dual focus on innovation and real-world impact, Synendos aims to set a new benchmark in how disabling symptoms are treated and managed. About Synendos Synendos is a clinical-stage, neuroscience company developing breakthrough therapies for neuropsychiatric and other central nervous system (CNS) disorders such as anxiety disorders, PTSD and other indications. We utilize the modulation of a new drug target in the endocannabinoid system (ECS) that enables restoration of the natural functioning of the brain. Synendos’ lead drug candidate, SYT-510, belongs to a novel class of ECS modulators named Selective Endocannabinoid Reuptake Inhibitors (SERIs). SERIs represent first-in-class, new chemical entities that modulate the ECS through a self-limiting mode of action (MoA) with the potential to deliver meaningful benefits to patients. This novel MoA has the potential to combine treatment of a range of symptoms with sustained efficacy in large patient populations together with the potential to address a key unmet need, that of chronic tolerability, allowing more patients to stay on treatment and regain an improved quality of life. synendos.com About SERIsOur lead candidate, SYT-510, belongs to a novel class of ECS modulators named SERIs. SERIs are first-in-class endocannabinoid system (ECS) modulators that restore altered ECS signaling in disease conditions with a gentle and selective increase of endocannabinoid levels by inhibiting a newly identified drug target. SERIs act with a pro-homeostatic, self-limiting mechanism of action that enables a fine-tuned modulation of synaptic transmission in major neuronal circuits in the CNS. SERIs’ new mode of action represents an innovative and potentially safer therapeutic approach to multiple CNS disorders such as anxiety, mood and stress-related conditions, and others. For more information please contact: Synendos Therapeutics AGO Public Relations GmbHSimon RussellO’Patrick WilsonSimon.Russell@synendos.como@os-pr.com+41 79 138 5840+41 78 888 4332

临床2期临床1期临床结果

2024-01-18

·PRNewswire

Synendos Therapeutics AG Granted EMA Clinical Trial Authorisation for first-in-class Endocannabinoid System modulator, SYT-510

Synendos Therapeutics transitions to a clinical-stage biotech company developing innovative Endocannabinoid System (ECS) treatments for neuropsychiatric, neuroinflammatory and other Central Nervous System (CNS) disorders Clinical Trial will investigate the safety, tolerability and pharmacokinetics of Synendos' first-in-class ECS modulator BASEL, Switzerland, Jan. 18, 2024 /PRNewswire/ -- Synendos Therapeutics AG (Synendos), a world leader in innovative Endocannabinoid System (ECS) treatments, today announces that it has received approval from the European Medicines Agency (EMA) to commence the Phase 1 'first-in-human' clinical trial of its lead asset, SYT-510, a first-in-class inhibitor that modulates a newly identified drug target in the Endocannabinoid System to restore healthy brain physiology. The randomized, double-blind, placebo-controlled study will investigate the safety, tolerability and pharmacokinetics of single-ascending doses of SYT-510 in healthy adult participants. Synendos is developing selective endocannabinoid reuptake inhibitors (SERIs) that influence the balance of the ECS in a novel mode of action. The ECS is a key neuromodulator system in the CNS which plays a significant role in how the body responds to stress. By rebalancing and restoring endogenous cannabinoid levels that are dysregulated in certain pathological conditions, this new mode of action has the potential to rebalance brain function in a holistic and pro-homeostatic way to treat neuropsychiatric disorders such as Post-Traumatic Stress Disorder (PTSD). Dr Andrea Chicca, Co-Founder and Chief Executive Officer of Synendos, commented: "The transition to a clinical stage company marks a significant milestone and step forward for Synendos and for SYT-510, the first candidate in our new class of SERI molecules. More than a decade of research resulted in our identification of a completely new mechanism for treating complex neuropsychiatric conditions, and this has already demonstrated very promising pre-clinical results. With no new treatments available in this area for over 25 years, advances are desperately needed. By addressing this unmet need with our novel technology, we have the potential to offer those struggling with anxiety, mood and stress-related disorders a differentiated, safe and effective way to alleviate symptoms through the holistic rebalancing of brain physiology." Notes to Editors: About Synendos Therapeutics AG Synendos Therapeutics AG (Synendos) is a biopharmaceutical company developing first-in-class therapies to restore the healthy balance of brain physiology and meet the growing need for holistic and safe treatments for neuropsychiatric, neuroinflammatory and other Central Nervous System (CNS) disorders. A world leader in innovative Endocannabinoid System (ECS) treatments, Synendos is developing a new class of small molecules – selective endocannabinoid reuptake inhibitors (SERIs) – aimed at restoring the natural functioning of the ECS in the brain with the potential for treating a wide range of CNS disorders. Spun out of the University of Bern and incorporated in April 2019, the Company's novel technology stems from more than 10 years of solid research on endocannabinoid biology and pharmacology carried out by co-founders, Professor Jürg Gertsch and Dr. Andrea Chicca. For more information, please visit . About SERIs Selective Endocannabinoid Reuptake Inhibitors (SERIs) are first-in-class endocannabinoid system modulators that mildly and selectively increase endogenous cannabinoids levels by inhibiting a newly identified drug target. SERIs act with a pro-homeostatic, self-limiting mechanism of action that enables a fine-tuned modulation of synaptic transmission in major neuronal circuits in the CNS. SERIs' new mode of action represents an innovative and potentially safer therapeutic approach to CNS disorders associated with anxiety, mood and stress-related conditions. SOURCE Synendos Therapeutics

临床1期

100 项与 SYT-510 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
神经精神综合征	临床申请批准	欧盟	Synendos Therapeutics AG	2024-01-18
创伤后应激障碍	临床前	瑞士	University of Bern	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06670950 (GlobeNewswire) 人工标引	临床1期	-	60	SYT-510	齋獵觸鹹鹹糧製廠糧襯(夢觸夢選願簾製鑰鏇鹹) = none 襯廠鑰簾網窪鹽鬱壓襯 (範築選衊鑰蓋積製築壓 )	积极	2025-09-24