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神经疾病治疗药物开发商Ceruvia筹集800万美元融资,以完成其专有非致幻LSD类似物治疗丛集性头痛的综合1/2期临床试验

Ceruvia Raises $8 Million to Complete Integrated Phase 1/2 Trial of Proprietary Non-Hallucinogenic LSD Analog for Cluster Headache

CISION 等信源发布 2026-08-03 22:00

可切换为仅中文


Founder-backed investment supports accelerated clinical development through a fully funded Phase 1/2 program

创始人支持的投资通过全额资助的1/2期临床试验项目,加速临床开发进程

GREENWICH, Conn.

康涅狄格州格林威治

,

Aug. 3, 2026

2026年8月3日

/PRNewswire/ -- Ceruvia Lifesciences, a leading neurotransformational biopharmaceutical company, today announced an $8 million investment to advance the clinical development of BOL-148, using its proprietary non-hallucinogenic LSD analog for the treatment of cluster headache. The investment fully funds this next stage of clinical development for BOL-148.

/美通社/ -- 领先的神经转型生物制药公司Ceruvia Lifesciences今日宣布获得800万美元投资,用于推进BOL-148的临床开发。该药物利用其专有的非致幻LSD类似物,用于治疗丛集性头痛。这笔投资将全额资助BOL-148下一阶段的临床开发。

The company will conduct an integrated Phase 1/2 clinical study designed to efficiently bridge from healthy volunteer dose escalation into proof-of-concept evaluation in patients with cluster headache within a single clinical study..

该公司将开展一项整合的1/2期临床研究,旨在通过单一临床试验,高效地将健康志愿者的剂量递增研究过渡至丛集性头痛患者的概念验证评估。

Part 1 of the study will be a standard Phase 1 single ascending dose evaluation of Ceruvia's drug candidate in healthy adults.  Part 2 is designed as a randomized, placebo-controlled Phase 2 study in patients with cluster headache meant to demonstrate the safety and efficacy of BOL-148 in this population, while also exploring dose response and durability of effect..

该研究的第一部分将在健康成年人中对Ceruvia的候选药物进行标准的I期单次递增剂量评估。第二部分设计为一项针对丛集性头痛患者的随机、安慰剂对照II期研究,旨在证明BOL-148在该人群中的安全性和有效性,同时探索剂量反应关系及疗效的持久性。

Ceruvia expects to submit its Clinical Trial Application (CTA) in Germany in September 2026, with first participant enrollment expected in the fourth quarter of 2026. The Phase 1 portion of the study is expected to generate top-line data during the second quarter of 2027 at which time it will progress to the Phase 2 proof-of-concept portion of the study.

Ceruvia预计将于2026年9月在德国提交临床试验申请(CTA),并预计于2026年第四季度启动首位受试者入组。该研究的I期部分预计将在2027年第二季度产生初步数据,届时将进入研究的II期概念验证阶段。

Results of this trial will support the design and execution of a phase 3 pivotal trial in both the US and EU..

本试验的结果将为在美国和欧盟开展的关键性III期临床试验的设计与实施提供支持。

'We've reached an important milestone in the evolution of the BOL-148 program,' said Carey Turnbull, Founder and CEO of Ceruvia Lifesciences. 'Over the past two years we've refined both the science and the development strategy behind this program. By committing the capital required to complete this integrated Phase 1/2 study, we're now in a position to evaluate both the safety and therapeutic potential of BOL-148 within a single clinical study.'.

“我们在BOL-148项目的演进过程中达到了一个重要的里程碑,”Ceruvia Lifesciences的创始人兼首席执行官Carey Turnbull表示。“在过去两年中,我们完善了该项目背后的科学基础和发展策略。通过投入完成这项整合性1/2期临床试验所需的资金,我们现在能够在单一的临床研究中评估BOL-148的安全性和治疗潜力。”

NYPRG-101 (BOL-148) is a proprietary, non-hallucinogenic LSD analog being developed as a potential treatment for cluster headache. The program builds on encouraging preliminary clinical observations reported in a trial conducted by Harvard Medical School in which patients with chronic cluster headache achieved complete and durable response, as well as Ceruvia's own Phase 1 safety experience in healthy volunteers..

NYPRG-101(BOL-148)是一种专有的、非致幻的LSD类似物,正在开发作为丛集性头痛的潜在治疗方法。该计划基于哈佛大学医学院进行的一项试验中报告的令人鼓舞的初步临床观察结果,在该试验中,患有慢性丛集性头痛的患者实现了完全且持久的反应,以及Ceruvia自身在健康志愿者中的第一阶段安全性经验。

Cluster headache is one of the most severe neurological pain disorders, often referred to as the 'suicide headache' because of its extreme severity. Current treatment options remain limited, particularly for chronic cluster headache, where there are no FDA-approved preventive therapies. Ceruvia believes NYPRG-101 has the potential to offer a differentiated treatment capable of producing durable remission following a short course of therapy..

丛集性头痛是最严重的神经性疼痛疾病之一,因其极度剧烈而常被称为“自杀性头痛”。目前的治疗选择仍然有限,尤其是对于慢性丛集性头痛,尚无任何获得美国食品药品监督管理局(FDA)批准的预防性疗法。Ceruvia 认为,NYPRG-101 有望提供一种差异化的治疗方案,在短期疗程后实现持久的缓解。

About Ceruvia Lifesciences

关于 Ceruvia 生命科学公司

Founded in 2017, Ceruvia Lifesciences is a clinical-stage biopharmaceutical company with a mission to improve the lives of underserved patients suffering from neurological and psychiatric disorders. Founded by Carey Turnbull, Ceruvia is relentlessly focused on the development and commercialization of neurotransformational medicines to deliver meaningful relief to patients suffering from hard-to-treat headache disorders, OCD and substance abuse disorder.

Ceruvia Lifesciences 成立于2017年,是一家处于临床阶段的生物制药公司,其使命是改善患有神经和精神疾病且医疗资源不足患者的生活。由 Carey Turnbull 创立的 Ceruvia 始终致力于开发和商业化神经转化药物,为患有难治性头痛疾病、强迫症(OCD)和物质滥用障碍的患者提供有意义的缓解。

For too long, these communities have been poorly understood and under-served. At Ceruvia, we believe they no longer have to live this way. With a long history of partnership with leading researchers at Yale University School of Medicine, NYU School of Medicine and Harvard Medical School, Ceruvia is undertaking clinical research in order to help patients return to living their lives to the fullest..

长期以来,这些社区一直被误解且服务不足。在Ceruvia,我们相信他们不再需要这样生活。凭借与耶鲁大学医学院、纽约大学医学院和哈佛医学院的领先研究人员长期合作的历史,Ceruvia正在进行临床研究,以帮助患者重新过上充实的生活。

For more information, please visit

更多信息,请访问

www.ceruvialifesciences.com

www.ceruvialifesciences.com

Media contact:

媒体联系人:

Chris Koddermann

克里斯·科德曼

Tel: +41 (79) 434 25 78

电话:+41 (79) 434 25 78

E-mail:

电子邮件:

[email protected]

[email protected]

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SOURCE Ceruvia Lifesciences

来源:Ceruvia Lifesciences

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