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Gilgamesh's lead asset, bretisilocin (GM-2505), is a potential best-in-class psychedelic compound currently in Phase 2 development for the treatment of major depressive disorder (MDD).
吉尔伽美什的主要资产布雷西洛辛(GM-2505)是一种潜在的同类最佳迷幻化合物,目前正处于治疗重度抑郁症(MDD)的二期开发阶段。
Bretisilocin is a novel, short-acting serotonin (5-HT)2A receptor agonist and 5-HT releaser.
布雷蒂西洛辛是一种新型的、短效的血清素(5-HT)2A受体激动剂和5-HT释放剂。
NORTH CHICAGO, Ill.
伊利诺伊州北芝加哥
and
和
NEW YORK
纽约
,
,
Aug. 25, 2025
2025年8月25日
/PRNewswire/ -- AbbVie (NYSE:
/PRNewswire/ -- 艾伯维 (NYSE:
ABBV
艾伯维
) 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).
)和吉尔伽美什制药公司(“Gilgamesh”)今天宣布了一项最终协议,根据该协议,AbbVie将收购Gilgamesh的主要研究候选药物,该药物目前正在临床开发中,用于治疗中度至重度重度抑郁症(MDD)患者。
Psychedelic compounds, including 5-HT
致幻化合物,包括5-HT
2A
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,已被认可为潜在的治疗心理健康障碍(如重度抑郁症MDD)的方法。然而,现有此类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
布雷蒂西洛辛,一种5-HT
2A
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,旨在应对这类化合物中观察到的开发挑战。布雷替西洛辛被证明能产生较短的精神活性体验,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
布雷西洛辛在重度抑郁症(MDD)的2a期研究中取得了积极的初步结果。
announced
宣布
, 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,这一结果由以下指标衡量:
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).
蒙哥马利-奥斯伯格抑郁评定量表 (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总分从基线降低了21.6点,而对照组仅降低了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,”他表示。
Roopal Thakkar
鲁帕尔·塔卡尔
, 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晚期临床开发。
'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进创新治疗的承诺使他们成为推动布雷蒂西洛辛快速发展的理想合作伙伴,同时也使Gilgamesh能够继续追求我们开发针对复杂心理健康和神经疾病的新颖、变革性疗法的更广泛使命,”该公司表示。
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 .
,其中包括首付款和发展里程碑付款。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)、心脏安全性ibogaine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,Centerview Partners LLC担任独家财务顾问,Ropes & Gray LLP担任法律顾问。
About AbbVie
关于艾伯维
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.
艾伯维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,并应对未来的医疗挑战。我们努力在包括免疫学、肿瘤学、神经科学和眼科护理在内的几个关键治疗领域对人们的生活产生显著影响,同时也在我们的艾尔建美学产品和服务组合中发挥重要作用。
For more information about AbbVie, please visit us at .
欲了解有关艾伯维的更多信息,请访问我们的网站 。
www.abbvie.com
www.abbvie.com
. Follow @abbvie on
关注 @abbvie
LinkedIn,
LinkedIn,
,
,
,
,
X (formerly Twitter)
X(前称Twitter)
and
和
YouTube.
YouTube。
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,以转变精神疾病治疗模式,从症状管理转向速效且持久的疗法。吉尔伽美什设计通过既有机制发挥作用的疗法,这些疗法在安全性、有效性和患者可及性方面均经过优化。
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。欲了解该公司的治疗产品线更多信息,请访问。
https://www.gilgameshpharmaceutical.com/
https://www.gilgameshpharmaceutical.com/
. Follow Gilgamesh Pharmaceuticals on
关注吉尔伽美什制药公司
领英
and
和
X
X
.
。
Forward-Looking Statements
前瞻性声明
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words 'believe,' 'expect,' 'anticipate,' 'project' and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements.
本新闻稿中的某些陈述,或可能被视为1995年《私人证券诉讼改革法案》所指的前瞻性陈述。 “相信”、“预期”、“预计”、“预测”等词语及其相似表达和未来或条件动词的使用,通常用于识别前瞻性陈述。
AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations.
AbbVie提醒,这些前瞻性陈述受到可能导致实际结果与前瞻性陈述中明示或暗示的结果存在重大差异的风险和不确定性的约束。这些风险和不确定性包括但不限于知识产权方面的挑战、来自其他产品的竞争、研发过程中固有的困难、不利的诉讼或政府行为、适用于我们行业的法律法规的变化、全球宏观经济因素的影响(如经济衰退或不确定性、国际冲突、贸易争端和关税),以及与全球业务运营相关的其他不确定性和风险。
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, 'Risk Factors,' of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information.
有关可能影响艾伯维公司运营的经济、竞争、政府、技术及其他因素的更多信息,请参阅艾伯维公司2024年Form 10-K年度报告第1A项“风险因素”,该报告已提交给美国证券交易委员会,并通过其Form 10-Q季度报告及艾伯维随后向美国证券交易委员会提交的其他文件进行更新、补充或取代。
AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law..
艾伯维没有义务,也明确拒绝因后续事件或发展而公开发布对前瞻性声明的任何修订,除非法律要求。
AbbVie Media:
艾伯维媒体:
Liz Tang, Ph.D.
唐莉兹,博士
Liz.Tang@abbvie.com
丽兹·唐@艾伯维.com
Gligamesh Media:
吉尔伽美什媒体:
media@gilgameshpharmaceutical.com
媒体@gilgameshpharmaceutical.com
AbbVie Investors:
艾伯维投资者:
Liz Shea
莉兹·谢伊
Liz.Shea@abbvie.com
丽兹·谢伊@abbvie.com
Gilgamesh Investors:
吉尔伽美什投资者:
Laszlo Kiss, Ph.D.
拉斯洛·基斯,博士
laszlo@gilgameshpharmaceutical.com
拉斯洛@吉尔伽美什制药公司.com
SOURCE AbbVie
来源:艾伯维
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