Annual Awards Program Recognizes Breakthrough Life Sciences & Biotechnology Innovation

年度奖项计划表彰生命科学与生物技术领域的突破性创新

Around the World

环游世界

LOS ANGELES

洛杉矶

,

，

Nov. 5, 2026

2026年11月5日

/PRNewswire/ --

/美通社/ --

Spinogenix, Inc.

Spinogenix公司

, a clinical-stage biopharmaceutical company developing first-in-class synaptic regenerative and corrective therapeutics, today announced it has been awarded 'Regenerative Therapeutics Company of the Year' in the sixth annual BioTech Breakthrough Awards program conducted by

，一家处于临床阶段、致力于开发首创类突触再生与矫正疗法的生物制药公司，今日宣布其在由主办的第六届年度“BioTech Breakthrough Awards”评选中荣获“年度再生疗法公司”奖项。

BioTech Breakthrough

生物科技突破

, a leading independent market intelligence organization that evaluates and recognizes standout life sciences and biotechnology companies, products and services around the globe.

，一家领先的独立市场情报机构，负责评估和认可全球杰出的生命科学和生物技术公司、产品及服务。

Spinogenix is pioneering first-in-class, investigational therapeutics that have the potential to serve as restorative medicine for some of the most devastating neurological conditions, helping restore brain synapses to improve the lives of patients worldwide. This is done by developing small-molecule oral therapeutics that can penetrate the blood-brain barrier to actively regenerate lost synapses or correct synaptic dysfunction in the brain.

Spinogenix 正在开创同类首创的在研疗法，这些疗法有望成为某些最具破坏性神经系统疾病的修复性药物，通过恢复大脑突触来改善全球患者的生活。该公司致力于开发能够穿透血脑屏障的小分子口服疗法，以主动再生丢失的突触或纠正大脑中的突触功能障碍。

Spinogenix's lead candidate, tazbentetol (SPG302), is a first-in-class Transient Activator of Glutamatergic Synaptogenesis (TAGS). Its second clinical program, codabakalner (SPG601), is a first-in-class synaptic corrective therapy targeting BK channels for Fragile X syndrome (FXS) and autism. Spinogenix has also shown cross-indication activity throughout its pipeline, demonstrating that active synaptic regeneration and correction can lead to tangible functional recovery:.

Spinogenix 的首要候选药物 tazbentetol（SPG302）是首个谷氨酸能突触发生瞬时激活剂（TAGS）。其第二项临床项目 codabakalner（SPG601）是首个针对脆性 X 综合征（FXS）和自闭症的 BK 通道靶向突触矫正疗法。Spinogenix 还在其产品管线中展示了跨适应症的活性，表明活跃的突触再生和矫正能够带来切实的功能恢复。

In Alzheimer's Disease, a Phase 2a trial showed tazbentetol producing rapid cognitive improvements within four weeks that also lasted through a 24-week open-label extension. Long-term data have shown continued cognitive benefits, and patients experienced real-world improvements, such as regaining the ability to read.

在阿尔茨海默病的一项2a期临床试验中，tazbentetol在四周内显示出快速的认知改善，并且这种效果持续到了24周的开放标签扩展阶段。长期数据显示持续的认知益处，患者在实际生活中也取得了改善，例如重新获得了阅读能力。

In a Phase 2a trial, 82% of Amyotrophic Lateral Sclerosis (ALS) patients have shown a stable or improved rate of decline, with improvements in brain activity biomarkers. An FDA-authorized Expanded Access Program has been launched for patients ineligible for trials, which the FDA has since authorized to expand to 400 patients..

在一项2a期临床试验中，82%的肌萎缩侧索硬化症（ALS）患者表现出病情恶化速率稳定或改善，且脑部活动生物标志物有所好转。针对不符合试验入组条件的患者，已启动一项获美国食品药品监督管理局（FDA）批准的扩大访问计划，此后FDA已批准将该计划扩展至400名患者。

In addition, a Phase 2 trial for Schizophrenia patients has shown that tazbentetol can achieve greater PANSS symptom reductions over placebo. A 'triple-action' mechanism targets glutamatergic synapse loss and addresses positive, negative, and cognitive symptoms simultaneously. Spinogenix has also applied its candidate to Ophthalmology, publishing preclinical evidence demonstrating that tazbentetol preserves retinal ganglion cells and synaptic connectivity, protects the optic nerve, and reverses decreases in Pattern Electroretinogram amplitude in both glaucoma and diabetic retinopathy mouse models.

此外，一项针对精神分裂症患者的II期临床试验显示，与他莫昔芬相比，tazbentetol能够更显著地降低PANSS症状评分。其“三重作用”机制靶向谷氨酸能突触丢失，同时改善阳性、阴性和认知症状。Spinogenix还将该候选药物应用于眼科领域，并发表了临床前研究证据，表明tazbentetol在青光眼和糖尿病视网膜病变小鼠模型中均能保护视网膜神经节细胞及突触连接性，保护视神经，并逆转模式视网膜电图振幅的下降。

Tazbentetol may offer a new approach to preserving or restoring visual function..

Tazbentetol 可能为保护或恢复视觉功能提供一种新方法。

Codabakalner, a novel, oral investigational small molecule, is the first positive modulator of BK channels to be clinically evaluated in patients with FXS, the leading inherited cause of intellectual disability and a leading known genetic cause of autism. In a Phase 2a study published in Scientific Reports, codabakalner reduced elevated gamma-band EEG power in adult men with FXS, alongside improvements in executive function and selective attention.

Codabakalner 是一种新型的口服在研小分子药物，是首个在脆性 X 综合征（FXS）患者中进行临床评估的 BK 通道正向变构调节剂；FXS 是遗传性智力障碍的首要病因，也是已知的自闭症主要遗传成因之一。在《科学报告》（Scientific Reports）发表的一项 IIa 期研究中，Codabakalner 降低了成年男性 FXS 患者升高的伽马频段脑电图功率，并改善了执行功能和选择性注意力。

Codabakalner is now being evaluated in CLARITY (NCT07439510), an adaptive Phase 2b/3 basket trial in FXS supported by grant funding from the FRAXA Research Foundation. In October 2026, Spinogenix expanded CLARITY to include its first study in idiopathic autism spectrum disorder, a Phase 2b study that uses EEG screening to enroll participants who share the elevated gamma-band signature seen in Fragile X.

Codabakalner 目前正在 CLARITY 研究（NCT07439510）中接受评估，这是一项针对脆性 X 综合征（FXS）的适应性 IIb/III 期篮子试验，由 FRAXA 研究基金会的资助支持。2026 年 10 月，Spinogenix 扩大了 CLARITY 研究的范围，将其首次扩展至特发性自闭症谱系障碍领域，开展一项 IIb 期研究，该研究利用脑电图（EEG）筛查来招募具有与脆性 X 综合征所见相似的 gamma 频段特征升高的受试者。

Codabakalner has received FDA Orphan Drug and Fast Track designations and EMA orphan designation for FXS..

Codabakalner 已获得美国食品药品监督管理局（FDA）针对脆性X综合征（FXS）的孤儿药资格和快速通道资格，以及欧洲药品管理局（EMA）的孤儿药资格认定。

'For decades, neurological drug development has achieved only slowing disease decline. Our cross-indication clinical success shows progress towards changing the treatment paradigm from managed decline to structural recovery in neurological conditions, and the development of a novel regenerative therapy,' said Dr.

“数十年来，神经类药物研发仅能延缓疾病恶化。我们在跨适应症临床试验中取得的成功，表明我们正朝着将神经系统疾病的治疗范式从‘控制性衰退’转变为‘结构性恢复’的方向迈进，并推动一种新型再生疗法的开发。”博士说。

Stella Sarraf, CEO and Founder of Spinogenix. 'It's a great honor to accept this recognition from BioTech Breakthrough. When I founded Spinogenix, restoring synaptic connections in the brain was a bold idea few believed was possible. Doing right by patients has been our moral compass from day one, and it drives every decision we make, from expanding access to tazbentetol for people living with ALS to using brain-wave screening to identify the people with autism most likely to benefit from codabakalner.

Spinogenix 首席执行官兼创始人 Stella Sarraf 表示：“荣获 BioTech Breakthrough 的认可，我深感荣幸。在创立 Spinogenix 时，恢复大脑突触连接是一个大胆的想法，当时很少有人相信其可行性。始终以患者利益为重是我们自成立之初就秉持的道德准则，它驱动着我们做出的每一项决策，从扩大肌萎缩侧索硬化症（ALS）患者获取 tazbentetol 的渠道，到利用脑电波筛查技术识别最有可能从 codabakalner 治疗中获益的自闭症人群。”

This recognition belongs to the patients, families and clinicians who have trusted us with this work.'.

这份荣誉属于信任我们开展这项工作的患者、家属和临床医生。

The life sciences and biotechnology sector is rapidly redefining how diseases are discovered, diagnosed and treated, transforming one of the world's most critical industries. From genomics and gene editing to AI-powered drug discovery, cell and gene therapies, and advanced bioprocessing, biotechnology is delivering faster breakthroughs, more personalized care and better outcomes for patients around the world..

生命科学和生物技术领域正在迅速重新定义疾病的发现、诊断和治疗方式，从而变革全球最关键的行业之一。从基因组学和基因编辑到人工智能驱动的药物研发、细胞与基因疗法以及先进生物工艺，生物技术正为全球患者带来更快速的突破、更个性化的护理以及更好的治疗结果。

The mission of the annual BioTech Breakthrough Awards program is to recognize the innovators transforming the global biotechnology and life sciences landscape with breakthrough technology. The program conducts a comprehensive analysis of the companies redefining how therapies are researched, developed, manufactured and delivered.

年度“生物科技突破奖”项目旨在表彰那些凭借突破性技术重塑全球生物科技与生命科学格局的创新者。该项目对重新定义疗法研发、生产及交付方式的企业进行全面分析。

From AI-driven drug discovery platforms and precision medicine to synthetic biology, bioinformatics, and next-generation diagnostics and biomanufacturing, these innovations are enabling life sciences organizations to accelerate research, reduce development costs, bring life-changing treatments to market faster, and shape the future of human health..

从人工智能驱动的药物发现平台和精准医疗，到合成生物学、生物信息学以及下一代诊断和生物制造，这些创新正在使生命科学组织能够加速研究、降低开发成本、更快地将改变生命的治疗方案推向市场，并塑造人类健康的未来。

'Spinogenix represents a paradigm shift in regenerative therapeutics. Synapse loss is the unifying root cause behind motor, cognitive, and sensory decline across multiple devastating neurodegenerative and neuropsychiatric conditions. The regenerative field has historically focused on complex stem cell therapies, gene editing, and invasive tissue engineering rather than targeting actual neural circuit repair,' said Bryan Vaughn, Managing Director, BioTech Breakthrough.

“Spinogenix 代表了再生疗法领域的范式转变。突触丢失是导致多种毁灭性神经退行性疾病和神经精神疾病中运动、认知和感觉功能衰退的共同根本原因。再生医学领域历来专注于复杂的干细胞疗法、基因编辑和侵入性组织工程，而非针对实际的神经环路修复，”BioTech Breakthrough 执行董事布莱恩·沃恩（Bryan Vaughn）表示。

'By restoring physical synaptic connectivity, rather than merely slowing disease progression or managing symptoms, Spinogenix is redefining the boundaries of restorative medicine for some of the most devastating neurological conditions. We're awarding them with 'Regenerative Therapeutics Company of the Year.''.

“Spinogenix 通过恢复物理突触连接，而非仅仅延缓疾病进展或控制症状，正在重新定义针对某些最具破坏性神经系统疾病的再生医学边界。我们授予其‘年度再生疗法公司’奖项。”

About Spinogenix

关于 Spinogenix

Spinogenix, Inc. is a clinical-stage biopharmaceutical company developing first-in-class synaptic regenerative and corrective therapeutics for neurodegenerative, neuropsychiatric and neurodevelopmental diseases. Its pipeline includes codabakalner for Fragile X syndrome and autism, and tazbentetol for ALS, Alzheimer's disease and schizophrenia.

Spinogenix, Inc. 是一家处于临床阶段的生物制药公司，致力于开发用于神经退行性疾病、神经精神疾病和神经发育疾病的同类首创突触再生与矫正疗法。其产品管线包括用于治疗脆性X综合征和自闭症的codabakalner，以及用于治疗肌萎缩侧索硬化症（ALS）、阿尔茨海默病和精神分裂症的tazbentetol。

Learn more at .

了解更多，请访问。

spinogenix.com

spinogenix.com

.

。

Forward-Looking Statements

前瞻性陈述

This press release contains forward-looking statements, including statements about the design, enrollment, timing and potential outcomes of Spinogenix's clinical trials, including the CLARITY trial; the potential of EEG-based enrichment; the Expanded Access Program for tazbentetol; and the therapeutic potential of tazbentetol and codabakalner.

本新闻稿包含前瞻性陈述，包括有关Spinogenix临床试验（包括CLARITY试验）的设计、入组、时间安排及潜在结果的陈述；基于脑电图（EEG）的富集策略的潜力；他扎苯托尔的扩大 access 计划；以及他扎苯托尔和codabakalner的治疗潜力。

These statements are subject to risks and uncertainties that could cause actual results to differ materially. Tazbentetol and codabakalner are investigational and have not been approved by any regulatory authority. Spinogenix undertakes no obligation to update these statements except as required by law..

这些陈述受风险和不确定性的影响，可能导致实际结果出现重大差异。Tazbentetol 和 codabakalner 均为研究性药物，尚未获得任何监管机构的批准。除非法律另有要求，Spinogenix 不承担更新这些陈述的义务。

About BioTech Breakthrough

关于生物科技突破

Part of

部分

Tech Breakthrough

技术突破

, a leading market intelligence and recognition platform for global technology innovation and leadership, the BioTech Breakthrough Awards program is devoted to honoring excellence in life science and biotechnology solutions, services and companies. The BioTech Breakthrough Awards provide public recognition for the achievements of biotechnology companies and products in categories including BioPharma, Genomics, Therapeutics, Immunology, Food Science and BioAgriculture, and more.

作为全球技术创新与领导力的领先市场情报和认可平台，“生物科技突破奖”项目致力于表彰生命科学和生物技术解决方案、服务及公司的卓越成就。该奖项对生物科技公司在生物制药、基因组学、治疗学、免疫学、食品科学和生物农业等类别中的成就给予公众认可。

For more information visit .

更多信息请访问。

BioTechBreakthroughAwards.com

BioTechBreakthroughAwards.com

Tech Breakthrough LLC does not endorse any vendor, product or service depicted in our recognition programs, and does not advise technology users to select only those vendors with award designations. Tech Breakthrough LLC recognition consists of the opinions of the Tech Breakthrough LLC organization and should not be construed as statements of fact.

Tech Breakthrough LLC 不背书其认可计划中展示的任何供应商、产品或服务，也不建议技术用户仅选择那些获得奖项认定的供应商。Tech Breakthrough LLC 的认可代表该组织的观点，不应被解读为事实陈述。

Tech Breakthrough LLC disclaims all warranties, expressed or implied, with respect to this recognition program, including any warranties of merchantability or fitness for a particular purpose..

Tech Breakthrough LLC 就本认可计划不承担任何明示或暗示的担保，包括任何适销性或特定用途适用性的担保。

Investor Contact

投资者联系

Sasha Damouni Ellis

萨莎·达穆尼·埃利斯

Head of Investor Relations, Spinogenix

Spinogenix 投资者关系主管

ir@spinogenix.com

ir@spinogenix.com

SOURCE Spinogenix

来源：Spinogenix