SAN FRANCISCO and BOSTON, March 28, 2024 /PRNewswire/ -- MapLight Therapeutics, a clinical-stage biopharmaceutical company working to develop targeted novel therapeutics to improve the lives of patients suffering from debilitating CNS disorders, today announced initiation of a Phase 1 clinical trial evaluating ML-007/PAC, MapLight's extended-release fixed-dose combination formulation of the novel, investigational muscarinic agonist ML-007 and a precision-matched peripherally active anticholinergic (PAC).

旧金山和波士顿，2024年3月28日/PRNewswire/--MapLight Therapeutics是一家临床阶段的生物制药公司，致力于开发靶向新型疗法，以改善患有衰弱性中枢神经系统疾病的患者的生活，今天宣布启动一项评估ML-007/PAC的1期临床试验，MapLight的新型研究性毒蕈碱激动剂ML-007和精确匹配的外周活性抗胆碱能药物（PAC）的缓释固定剂量组合制剂。

This trial builds upon findings from three prior Phase 1 clinical trials evaluating safety and tolerability of ML-007 co-administered with the PAC..

该试验基于之前三项评估与PAC共同给药的ML-007安全性和耐受性的1期临床试验的结果。。

This four-cohort trial will evaluate the safety, tolerability and pharmacokinetics (PK) of several dose strengths of ML-007/PAC in healthy non-elderly and elderly adults.

这项四队列试验将评估健康非老年人和老年人中几种剂量强度的ML-007/PAC的安全性，耐受性和药代动力学（PK）。

'We are pleased with the continued progress of our ML-007 clinical development program.'

“我们对ML-007临床开发计划的持续进展感到高兴。”

'We are pleased with the continued progress of our ML-007 clinical development program,' stated Christopher Kroeger, M.D., MBA, Chief Executive Officer and Founder. 'We have already evaluated the safety and tolerability profile of ML-007 dosed alone or with the PAC in three clinical trials and observed favorable tolerability results in adults, including in elderly subjects.

首席执行官兼创始人、工商管理硕士克里斯托弗·克罗格（ChristopherKroeger）表示，我们对ML-007临床开发项目的持续进展感到高兴我们已经在三项临床试验中评估了单独或与PAC一起给药的ML-007的安全性和耐受性，并观察到成人（包括老年受试者）的良好耐受性结果。

Data from this fourth Phase 1 trial will inform the ML-007/PAC dosing regimen to bring forward into our planned Phase 2 trials in schizophrenia and Alzheimer's disease psychosis. We look forward to initiating our first Phase 2 trial of ML-007/PAC in schizophrenia later this year.'

来自第四阶段1试验的数据将为ML-007/PAC给药方案提供信息，以推进我们计划的精神分裂症和阿尔茨海默病精神病的2期试验。我们期待着在今年晚些时候启动ML-007/PAC治疗精神分裂症的第一个2期临床试验。”

'There still remains a profound level of unmet need in the treatment of schizophrenia with about 60% of patients having only a partial response or no response to treatment,' said John Kane M.D., Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. 'The clinical trial evidence for muscarinic receptor agents has been very encouraging, and I believe this new class of agents has the potential to improve the overall treatment of schizophrenia.'About ML-007ML-007 is an investigational, CNS-penetrant muscarinic receptor agonist designed to target M1 and M4 muscarinic receptor subtypes with no direct activity on dopamine receptors.

霍夫斯特拉/诺思韦尔医学院（Hofstra/Northwell）的约翰·凯恩（JohnKane M.D.）、唐纳德（Donald）和芭芭拉·祖克（BarbaraZucker）医学院（School of Medicine）说：“精神分裂症的治疗仍有很大程度的需求未得到满足，大约60%的患者对治疗只有部分反应或没有反应。”毒蕈碱受体药物的临床试验证据非常令人鼓舞，我相信这类新型药物有可能改善精神分裂症的整体治疗。”关于ML-007ML-007是一种研究性的中枢神经系统渗透性毒蕈碱受体激动剂，旨在靶向M1和M4毒蕈碱受体亚型，对多巴胺受体没有直接活性。

Deficits in M1 receptors are linked to schizophrenia, and M1 receptors directly regulate neural circuits known to be important in both psychosis and cognition. M4 receptors regulate a complementary neural circuit known to be important in psychosis.About ML-007/PACML-007/PAC, also referred to as ML-007C-MA, is an extended-release fixed-dose combination of the investigational, M1/M4 muscarinic agonist, ML-007, co-formulated with a peripherally acting anticholinergic (PAC).

M1受体的缺陷与精神分裂症有关，M1受体直接调节已知在精神病和认知中都很重要的神经回路。M4受体调节已知在精神病中很重要的互补神经回路。关于ML-007/PACML-007/PAC，也称为ML-007C-MA，是研究性M1/M4毒蕈碱激动剂ML-007与外周作用抗胆碱能药物（PAC）共同配制的缓释固定剂量组合。

ML-007/PAC was specifically designed to unlock the full potential of ML-007 by pairing it with a precision-matched anticholinergic and to optimize pharmacokinetic synchronization of its agonist and antagonist components, without sacrificing activation of both M1 and M4 receptors.About SchizophreniaSchizophrenia is a serious, debilitating mental illness characterized by disturbances in perception, thinking, emotional reaction, and behavior.

ML-007/PAC专门设计用于通过将其与精确匹配的抗胆碱能药物配对来释放ML-007的全部潜力，并优化其激动剂和拮抗剂成分的药代动力学同步，而不牺牲M1和M4受体的激活。关于精神分裂症chizophrenia是一种严重的，使人衰弱的精神疾病，其特征是感知，思维，情绪反应和行为障碍。

Schizophrenia can cause people to interpret reality abnormally and includes a combination of positive, negative, and cognitive symptoms. Approximately 60% of people with schizophrenia have no response or only a partial response to the.

精神分裂症可以导致人们异常地解释现实，包括积极，消极和认知症状的组合。大约60%的精神分裂症患者对精神分裂症没有反应或只有部分反应。