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12亿美元,艾伯维收购Gilgamesh Pharmaceuticals临床抑郁症新药

AbbVie to Acquire Gilgamesh Pharmaceuticals' Bretisilocin, a Novel, Investigational Therapy for Major Depressive Disorder, Expanding Psychiatry Pipeline

艾伯维 等信源发布 2025-08-25 21:26

可切换为仅中文


/ -- AbbVie (NYSE: ABBV) and Gilgamesh Pharmaceuticals Inc. ('Gilgamesh') today announced a definitive agreement under which AbbVie will acquire Gilgamesh's lead investigational candidate, currently in clinical development for the treatment of patients with moderate-to-severe major depressive disorder (MDD)..

/ -- 艾伯维(AbbVie,纽约证券交易所代码:ABBV)和吉尔伽美什制药公司(Gilgamesh Pharmaceuticals Inc.,“Gilgamesh”)今天宣布了一项最终协议,根据该协议,艾伯维将收购吉尔伽美什的主要在研候选药物,该药物目前正在针对中度至重度重度抑郁症(MDD)患者的治疗进行临床开发。

Psychedelic compounds, including 5-HT 2A

包括5-HT在内的迷幻化合物 2A

receptor agonists, have gained recognition as potential treatments for mental health disorders, such as MDD, because of their demonstrated rapid, robust and durable antidepressant effects. However, existing agents in this class are hampered by their long duration of psychoactive experience.

受体激动剂因具有快速、显著且持久的抗抑郁效果,已被认可为治疗重度抑郁症 (MDD) 等心理健康障碍的潜在疗法。然而,此类现有药物因其精神活性体验持续时间过长而受到限制。

Bretisilocin, a 5-HT 2A

布雷蒂西洛辛,一种5-HT 2A

receptor agonist and 5-HT releaser, is a novel, next-generation psychedelic compound designed to address development challenges observed within this class of compounds. Bretisilocin has been shown to exert a shorter duration of psychoactive experience, while retaining an extended therapeutic benefit..

受体激动剂和5-HT释放剂,是一种新型的下一代迷幻化合物,旨在解决该类化合物中观察到的开发挑战。布雷替西洛辛被证明具有较短的精神活性体验持续时间,同时保留了较长的治疗益处。

Positive topline results from a Phase 2a study of bretisilocin in MDD were recently

重度抑郁症(MDD)中布雷西洛辛的2a期研究近日取得了积极的初步结果。

, demonstrating a clinically impactful and statistically significant reduction in severity of depressive symptoms versus low dose active comparator, as measured by the

,与低剂量活性对照组相比,在抑郁症状的严重程度上表现出具有临床意义且统计学显著的减轻,这是通过以下方式衡量的:

Montgomery

蒙哥马利

-Åsberg Depression Rating Scale (MADRS) total score. At Day 14, a single dose (10mg) of bretisilocin demonstrated robust antidepressant effect with a -21.6 point change from baseline in MADRS total score compared to a -12.1 point change from baseline for the low dose (1mg) active comparator (p = 0.003).

-Åsberg抑郁评定量表(MADRS)总分。在第14天,单剂量(10毫克)的布雷蒂西洛辛显示出显著的抗抑郁效果,与低剂量(1毫克)活性对照组相比,MADRS总分从基线下降了21.6点,而对照组仅下降了12.1点(p = 0.003)。

Bretisilocin was well tolerated with no serious adverse events..

布雷蒂西洛辛耐受性良好,无严重不良事件。

'The field of psychiatry represents one of the most challenging areas in medicine, with a significant need for innovative solutions,' said

“精神病学领域是医学中最具挑战性的领域之一,对创新解决方案有着显著的需求,”

Roopal Thakkar

鲁帕尔·塔卡卡尔

, M.D., executive vice president, research and development and chief scientific officer, AbbVie. 'This acquisition underscores our commitment to broadening and enhancing psychiatric care by investing in novel treatment approaches with the potential to reach patients for whom other treatments have been ineffective.

医学博士,艾伯维执行副总裁,研发部门及首席科学官。“此次收购重申了我们通过投资具有潜力的新型治疗方法来拓宽和加强精神疾病治疗的承诺,这些治疗方法有望惠及其他疗法无效的患者。”

We look forward to advancing bretisilocin to late-stage clinical development.'.

我们期待将布雷蒂西洛辛推进到后期临床开发。

'AbbVie's leadership in neuroscience and commitment to advancing innovative treatments make them the ideal partner to advance bretisilocin rapidly forward while enabling Gilgamesh to continue pursuing our broader mission of developing novel, transformative therapies for complex mental health and neurological conditions,' said .

“AbbVie在神经科学领域的领导地位和推动创新治疗的承诺使他们成为快速推进布雷替西林的理想合作伙伴,同时也使Gilgamesh能够继续追求我们更广泛的使命,即为复杂的心理健康和神经系统疾病开发新颖、变革性的疗法,”他表示。

Jonathan Sporn

乔纳森·斯波恩

, M.D., chief executive officer at Gilgamesh Pharmaceuticals.

医学博士,Gilgamesh Pharmaceuticals首席执行官。

Under the terms of the agreement, AbbVie will acquire Gilgamesh's bretisilocin program for up to

根据协议条款,AbbVie将收购Gilgamesh的布雷替索辛项目,金额高达

$1.2 billion

12亿美元

, inclusive of an upfront payment and development milestones. Additionally, as part of the transaction, Gilgamesh will spin off a new entity that will operate under the name Gilgamesh Pharma Inc. to hold its employees and other programs, including its oral NMDA receptor antagonist blixeprodil (GM-1020), cardio-safe ibogaine analog, M1/M4 agonist program and existing .

,其中包括预付款和发展里程碑。此外,作为交易的一部分,Gilgamesh将分拆出一个新实体,该实体将使用Gilgamesh Pharma Inc.的名称运营,持有其员工和其他项目,包括其口服NMDA受体拮抗剂blixeprodil(GM-1020)、心脏安全的伊博格碱类似物、M1/M4激动剂项目以及现有的 。

collaboration

协作

with AbbVie. The transaction is subject to customary closing conditions.

与艾伯维公司。该交易需符合惯例的交割条件。

This transaction builds upon AbbVie and Gilgamesh's 2024 collaboration and option-to-license agreement to advance the development of next-generation therapies for the treatment of psychiatric disorders. This option-to-license remains in effect and will be transferred to Gilgamesh Pharma Inc. in connection with the spin-out..

此项交易基于艾伯维和吉尔伽美什2024年的合作及选择权许可协议,旨在推动针对精神疾病治疗的下一代疗法的开发。该选择权许可协议仍然有效,并将在分拆过程中转让给吉尔伽美什制药公司。

Advisors

顾问

For AbbVie, Covington & Burling LLP is acting as legal counsel. For Gilgamesh, Centerview Partners LLC is acting as exclusive financial advisor and Ropes & Gray LLP is acting as legal counsel.

对于艾伯维,科文顿·柏灵律师事务所担任法律顾问。对于吉尔伽美什,森特维尔合伙人有限公司担任独家财务顾问,罗普斯·格雷律师事务所担任法律顾问。

About AbbVie

关于AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio.

AbbVie的使命是发现并提供创新药物和解决方案,以解决当今严重的健康问题,并应对未来的医学挑战。我们力求在包括免疫学、肿瘤学、神经科学和眼科在内的几个关键治疗领域,以及我们Allergan Aesthetics产品组合中的产品和服务,对人们的生活产生显著影响。

About Gilgamesh Pharmaceuticals

关于吉尔伽美什制药公司

Gilgamesh Pharmaceuticals is a clinical-stage neuroscience biotech developing innovative, best-in-class new chemical entities that transform the treatment paradigm of psychiatric diseases, moving away from symptom management towards rapid-acting and durable therapies. Gilgamesh designs therapies acting through precedented mechanisms, which are optimized for safety, efficacy, and patient access.

吉尔伽美什制药是一家临床阶段的神经科学生物技术公司,致力于开发创新的、同类最佳的新化学实体,这些实体将改变精神疾病治疗模式,从症状管理转向速效且持久的疗法。吉尔伽美什设计的治疗方法通过成熟的机制发挥作用,并在安全性、有效性和患者可及性方面进行了优化。

Gilgamesh is advancing a diverse portfolio of programs, including blixeprodil (GM-1020), an oral NMDA receptor antagonist that is completing a Phase 2a study in Major Depressive Disorder in 2025. Learn more about the company's therapeutic pipeline at .

Gilgamesh正在推进多样化的项目组合,包括blixeprodil(GM-1020),这是一种口服NMDA受体拮抗剂,将于2025年完成针对重度抑郁症的二期a阶段研究。更多关于公司治疗管线的信息,请访问。