MapLight Therapeutics宣布启动其新型 M1/M4胆碱能激动剂 ML-007C-MA治疗精神分裂症的二期临床试验-动脉网

MapLight Therapeutics Announces Initiation of Phase 2 Trial of Its Novel M1/M4 Muscarinic Agonist ML-007C-MA for the Treatment of Schizophrenia

CISION 等信源发布 2025-07-07 20:00

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REDWOOD CITY, Calif.

加利福尼亚州红木城

，

July 7, 2025

2025年7月7日

/PRNewswire/ -- MapLight Therapeutics today announced the initiation of a Phase 2 study to evaluate the efficacy, safety and tolerability of ML-007C-MA, an investigational novel M

/PRNewswire/ -- MapLight Therapeutics 今日宣布启动一项二期研究，以评估 ML-007C-MA（一种新型的 M）的有效性、安全性和耐受性。

agonist, as a potential treatment for schizophrenia. The Phase 2 ZEPHYR study has been designed based on the results of an extensive Phase 1 development program that included 270 healthy volunteers.

激动剂，作为一种潜在的精神分裂症治疗方法。2期ZEPHYR研究是基于包含270名健康志愿者的广泛的1期开发项目的结果设计的。

'There is a significant need for new and innovative medicines for the treatment of schizophrenia, a disorder that impacts over 20 million people worldwide,' said

“全球有超过2000万人受到精神分裂症的影响，因此对于该疾病的新药和创新药物有着显著的需求，”他说。

Christopher Kroeger

克里斯托弗·克罗格

, M.D., M.B.A., Chief Executive Officer and Founder of MapLight. 'We are encouraged by the potential of muscarinic agonists to address the full spectrum of schizophrenia symptoms and remain committed to advancing ML-007C-MA to help meet the urgent needs of these patients.'

，医学博士，工商管理硕士，MapLight首席执行官兼创始人。“我们对毒蕈碱激动剂在解决精神分裂症全谱症状方面的潜力感到鼓舞，并将继续致力于推进ML-007C-MA，以帮助满足这些患者的迫切需求。”

The Phase 2 ZEPHYR study is a randomized, double-blind, placebo-controlled trial evaluating once- and twice-daily doses of ML-007C-MA in adults with a primary diagnosis of schizophrenia who are experiencing an acute exacerbation or relapse of symptoms. The study is expected to enroll approximately 300 patients throughout .

第二阶段的ZEPHYR研究是一项随机、双盲、安慰剂对照试验，评估ML-007C-MA每日一次和每日两次剂量，用于主要诊断为精神分裂症且正在经历急性症状恶化或复发的成人患者。该研究预计将在整个过程中招募约300名患者。

the United States

美国

. The primary endpoint of the study is the change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 5.

研究的主要终点是从基线到第5周阳性与阴性症状量表（PANSS）总分的变化。

'We are encouraged by the differentiated profile demonstrated by ML-007C-MA in Phase 1 studies, which included favorable safety and tolerability results with once- and twice-daily dosing, minimal titration requirements and no need for fasting, while achieving CSF exposures expected to be clinically relevant,' said .

“我们在第一阶段研究中受到ML-007C-MA所展示的差异化特性鼓舞，其中包括每日一次和两次给药的良好安全性和耐受性结果，几乎无需剂量调整且无需空腹，同时实现了预期具有临床意义的脑脊液暴露水平，”研究人员表示。

Erin Foff

erin foff

, M.D., Ph.D., Chief Medical Officer of MapLight. 'This Phase 2 study is designed to be adequately sized and well controlled to evaluate the efficacy, safety and tolerability profile at the doses selected.'

，医学博士，哲学博士，MapLight首席医学官。“这项二期研究的设计规模适中且控制良好，以评估所选剂量的疗效、安全性和耐受性。”

For more information about this study, visit: ClinicalTrials.gov (NCT07038876).

有关本研究的更多信息，请访问：ClinicalTrials.gov (NCT07038876)。

About ML-007/PAC

关于 ML-007/PAC

ML-007C-MA, also referred to as ML-007C/PAC, is an oral, extended-release, fixed-dose combination of the investigational M

ML-007C-MA，也被称为 ML-007C/PAC，是一种口服、缓释、固定剂量的组合，包含在研的 M 药物。

muscarinic agonist, ML-007, co-formulated with a peripherally acting anticholinergic (PAC). Potential differentiation for ML-007C-MA is driven by an optimized pharmacokinetic synchronization of its agonist and antagonist components in the periphery, without sacrificing strong activation of both M

毒蕈碱激动剂 ML-007 与外周作用抗胆碱药 (PAC) 联合配制。ML-007C-MA 的潜在差异化优势在于其在外周的激动剂和拮抗剂成分的药代动力学同步性优化，同时不削弱对 M 的强效激活。

and M

和 M

receptors in the central nervous system.

中枢神经系统中的受体。

About Schizophrenia

关于精神分裂症

Schizophrenia is a complex psychiatric disorder characterized by a range of symptoms that include positive symptoms of hallucinations, delusions, and disorganized thinking; negative symptoms of social withdrawal, decreased emotional expression, anhedonia, and apathy; and cognitive impairment, all of which are major drivers of disability due to significant impairment of social and occupational functioning.

精神分裂症是一种复杂的精神障碍，其特征是出现多种症状，包括幻觉、妄想和思维紊乱等阳性症状；社交退缩、情感表达减少、快感缺失和冷漠等阴性症状；以及认知功能损害，所有这些症状都是导致社会和职业功能严重受损的主要原因，从而造成残疾。

Schizophrenia is widely recognized as a chronic and debilitating condition, affecting approximately 3 million people in the US and 20 million globally. Schizophrenia remains one of the leading causes of disability and is associated with an increased risk for premature mortality..

精神分裂症被广泛认为是一种慢性且致残的疾病，影响美国约 300 万人和全球 2000 万人。精神分裂症仍然是导致残疾的主要原因之一，并且与过早死亡风险增加相关。

About MapLight

关于MapLight

MapLight Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders. The company was founded by globally recognized leaders in psychiatry and neuroscience research to address the lack of circuit-specific pharmacotherapies available for patients.

MapLight Therapeutics是一家临床阶段的生物制药公司，专注于改善中枢神经系统疾病患者的生活。该公司由全球公认的精神病学和神经科学研究领域的领导者创立，旨在解决目前缺乏针对特定神经回路的药物治疗的问题。

MapLight's discovery platform holds the potential to fill this void by identifying neural circuits causally linked to disease and targeting those circuits for therapeutic modulation..

MapLight的发现平台有潜力通过识别与疾病有因果关系的神经回路并针对这些回路进行治疗调节，从而填补这一空白。

Learn more at

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www.maplightrx.com

。

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