/PRNewswire/ -- Sensorium Therapeutics, Inc. (Sensorium), a neuroscience therapeutics company inspired by nature and guided by human biology to transform mental health treatment, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SNTX-2643, its lead anxiety program.

/PRNewswire/ -- 受自然启发并以人类生物学为指导的神经科学治疗公司 Sensorium Therapeutics, Inc.（Sensorium）今天宣布，美国食品药品监督管理局 (FDA) 已批准其主要焦虑症项目 SNTX-2643 的研究性新药 (IND) 申请。

With IND clearance secured, Sensorium enters a new stage of operational maturity, enabling first-in-human dosing and expanding the potential for strategic partnerships and downstream value creation. First in-human dosing begins in Q3 2025..

随着IND审批的通过，Sensorium进入了运营成熟的新阶段，实现了首次人体给药，并拓展了战略合作伙伴关系和下游价值创造的潜力。首次人体给药将于2025年第三季度开始。

Sensorium's current pipeline is powered by the company's discovery platform SensAI™, which holistically integrates comprehensive biological data to identify compounds with a high probability of clinical success.

Sensorium当前的管线由该公司的发现平台SensAI™驱动，该平台全面整合了全面的生物学数据，以识别具有高临床成功概率的化合物。

'A fast-acting, well–tolerated anxiolytic would be an important innovation for the hundreds of millions worldwide living with anxiety disorders,' said

“一种快速起效、耐受性良好的抗焦虑药将为全球数亿患有焦虑症的人带来重要的创新，”

Maurizio Fava

毛里齐奥·法瓦

, MD, Scientific Advisor to Sensorium and Chair of the Mass General Brigham Academic Medical Centers Psychiatry Department. 'FDA clearance of SNTX–2643 moves us one step closer to that goal.'

医学博士，Sensorium科学顾问，麻省总布里格姆学术医疗中心精神病学系主任。 “SNTX-2643获得FDA批准使我们向这一目标迈进了一步。”

SNTX-2643 is a first-in-class precision serotonin modulator designed to treat neuropsychiatric conditions including social anxiety disorder (SAD), a leading anxiety disorder underserved by current pharmacologic treatments. Re-engineered from a natural product with a long history of human use, SNTX-2643 could overcome many critical limitations commonly associated with benzodiazepine-like drugs by enabling rapid onset of action, reducing off-target side effects, and avoiding sedation.

SNTX-2643 是一种首创的精准血清素调节剂，旨在治疗包括社交焦虑障碍 (SAD) 在内的神经精神疾病，而社交焦虑障碍是当前药物治疗未能充分满足需求的主要焦虑症之一。SNTX-2643 源自一种具有悠久人类使用历史的天然产物，并经过重新设计，可实现快速起效、减少脱靶副作用并避免镇静，从而克服与苯二氮卓类药物相关的许多关键限制。

It acts through unique pharmacology distinct from SSRIs, which are limited by delayed onset and can paradoxically increase acute anxiety in the early stages of treatment..

它通过独特的药理作用于SSRIs不同，后者因起效延迟而受限，并且在治疗早期可能会矛盾地增加急性焦虑。

Co-Founder

联合创始人

Jacob Hooker

雅各布·胡克

appointed as CEO, affirms company vision

任命为首席执行官，确认公司愿景

Sensorium has appointed Jacob Hooker, PhD—co–founder and formerly endowed Harvard Medical School professor—as Chief Executive Officer. Dr. Hooker is a world-renowned expert in chemical neuroscience, biomarker development, and CNS pharmacology. He has co-founded and advised several biotech companies, including Eikonizo Therapeutics, Delix Therapeutics, and Rocket Science Health.

Sensorium 已任命 Jacob Hooker 博士——联合创始人，前哈佛医学院终身教授——为首席执行官。Hooker 博士是化学神经科学、生物标志物开发和中枢神经系统药理学领域世界知名的专家。他曾联合创立并为多家生物技术公司提供咨询，包括 Eikonizo Therapeutics、Delix Therapeutics 和 Rocket Science Health。

Dr. Hooker succeeds .

胡克博士成功了。

Sandra Glucksmann

桑德拉·格鲁克斯曼

, PhD, who will remain on Sensorium's Board of Directors and serve as a senior advisor.

，博士，他将继续留在Sensorium董事会并担任高级顾问。

'Leading Sensorium is a once-in-a-lifetime opportunity to change the course of neuropsychiatry that can't be realized through research alone,' said Dr. Hooker. 'We will help people living with mental health conditions by exploring nature's rich goldmine of medicinal compounds to discover and develop innovative therapies.

胡克博士说：“领导Sensorium是一个千载难逢的机会，可以改变神经精神病学的进程，而这仅靠研究是无法实现的。我们将通过探索大自然丰富的药用化合物宝库，帮助那些生活在心理健康问题中的人们，发现并开发创新疗法。”

Our approach starts with chemistry that co–evolved with humans, validates insights with modern neuroscience, and accelerates opportunities with AI. That combination can reshape how we treat brain and mental health conditions on a global scale.'.

我们的方法始于与人类共同进化的化学，通过现代神经科学验证见解，并利用人工智能加速机会。这种组合可以重塑我们在全球范围内治疗大脑和心理健康问题的方式。

Simba Gill named Sensorium Executive Chairman

Simba Gill 被任命为 Sensorium 执行主席

Simba Gill

辛巴·吉尔

, PhD, a current Board member, has been appointed Executive Chairman of Sensorium's Board of Directors. Dr. Gill has built and led multiple category–defining biotech companies, adding deep expertise in financing, business development, and commercialization to Sensorium's board. 'Jacob and the founding team's brilliance and track record, combined with Sensorium's data–rich platform, position the company for rapid value inflection,' said Dr. Gill..

，博士，现任董事会成员，已被任命为Sensorium董事会的执行主席。吉尔博士曾创建并领导多家定义类别的生物技术公司，为Sensorium董事会带来了在融资、业务发展和商业化方面的深厚专业知识。“雅各布和创始团队的才华与过往成就，结合Sensorium的数据丰富平台，使公司处于快速价值提升的有利位置，”吉尔博士表示。

'Sensorium is exactly the kind of company we are excited to back at this pivotal stage,' said Kevin Lalande, Founder & Managing Partner at Santé Ventures, adding, 'With an IND in hand, a differentiated platform, additional programs in epilepsy and Alzheimer's disease advancing quickly, and brilliant leadership, the company will illuminate new paths to safer, more effective mental health medications for millions globally.'.

“Sensorium正是我们在这一关键阶段非常乐意支持的公司，”Santé Ventures创始人兼管理合伙人凯文·拉兰德表示，并补充道：“凭借在手的IND、差异化的平台、快速推进的癫痫和阿尔茨海默病项目，以及卓越的领导团队，该公司将为全球数百万人开辟更安全、更有效的心理健康药物的新路径。”

Sensorium's current pipeline, powered by the company's SensAI™ discovery platform, is illustrated above. The platform mines natural bioactive materials with ethnobotanical records and applies rigorous neuroscientific and chemical analysis to identify broader and de-risked starting points for CNS drug discovery..

Sensorium当前的管线由该公司的SensAI™发现平台驱动，如上图所示。该平台挖掘具有民族植物学记录的天然生物活性材料，并运用严格的神经科学和化学分析，以确定更广泛且风险较低的中枢神经系统（CNS）药物发现起点。

About Sensorium

关于 Sensorium

Sensorium Therapeutics is a clinical–stage biotechnology company developing brain and mental health treatments that are derived from nature, mechanistically driven, clinically precise, and designed to help people thrive. Its proprietary SensAI platform integrates artificial intelligence, chemistry, and neuroscience to mine more than 50 million curated relationships across biology, pharmacology, clinical outcomes, and human experience to unlock broader and derisked starting points for CNS drug discovery. SensAI has already produced three differentiated programs in under three years—led by SNTX–2643, a first-in-class treatment for anxiety—and built a robust IP estate extending into the 2040s..

Sensorium Therapeutics是一家临床阶段的生物技术公司，致力于开发源自自然、机制驱动、临床精准且旨在帮助人们茁壮成长的脑部和心理健康治疗方法。其专有的SensAI平台整合了人工智能、化学和神经科学，挖掘生物学、药理学、临床结果和人类体验之间超过5000万条精心整理的关系，为中枢神经系统药物发现提供更广泛且降低风险的起点。在不到三年的时间里，SensAI已经产出了三个差异化项目——其中由SNTX-2643主导，这是一种用于治疗焦虑症的首创药物——并建立了一个延续至2040年代的强大知识产权资产。