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Evecxia Therapeutics and Quotient Sciences完成新型抑郁症治疗的I期临床里程碑

Evecxia Therapeutics and Quotient Sciences Complete Phase I Clinical Milestone for New Depression Treatment

CISION 等信源发布 2023-09-21 22:00

可切换为仅中文


Quotient Sciences' modified release capabilities enhance performance of EVX-101

Quotients Sciences的改进发布功能可增强EVX-101的性能

NOTTINGHAM, England, Sept. 21, 2023 /PRNewswire/ -- A drug development partnership between Evecxia Therapeutics and Quotient Sciences has resulted in the successful delivery of a Phase 1 clinical testing program for Evecxia's drug candidate EVX-101, which is in development for major depressive disorder (MDD)..

英格兰诺丁汉,2023年9月21日/PRNewswire/-Evecxia Therapeutics和Quotiences之间的药物开发合作伙伴关系已成功实施Evecxia候选药物EVX-101的1期临床试验计划,该计划正在开发中用于重度抑郁症(MDD)。。

Quotient Sciences' Translational Pharmaceutics® platform was used to develop and optimize the drug delivery mechanism of the EVX-101 technology and was a driving force behind the success of the clinical testing program.

Quotiences的TranslationalPharmaceutics®平台用于开发和优化EVX-101技术的药物输送机制,并且是临床测试计划成功背后的推动力。

Evecxia is the first company dedicated to realizing the therapeutic potential of amplifying serotonin synthesis to treat brain disorders like MDD. MDD is a major global health issue that affects 280 million people worldwide.

Evecxia是第一家致力于实现放大5-羟色胺合成治疗MDD等脑部疾病的治疗潜力的公司。MDD是影响全球2.8亿人的主要全球健康问题。

As part of its work, Evecxia is currently developing EVX-101 as an adjunctive treatment for MDD because many patients experience an inadequate response to first-line antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).

作为其工作的一部分,Evecxia目前正在开发EVX-101作为MDD的辅助治疗,因为许多患者对一线抗抑郁药如选择性5-羟色胺再摄取抑制剂(SSRIs)或5-羟色胺-去甲肾上腺素再摄取抑制剂(SNRIs)的反应不足。

EVX-101 is a novel, proprietary, gastro-retentive, sustained-release tablet formulation of 5-hydroxytryptophan (5-HTP), the natural precursor to serotonin, and low-dose carbidopa. 5-HTP is the active compound and carbidopa functions as an absorption enhancer for 5-HTP.

EVX-101是5-羟色氨酸(5-HTP)(血清素的天然前体)和低剂量卡比多巴的新型专有,胃保留,缓释片剂制剂。5-HTP是活性化合物,卡比多巴作为5-HTP的吸收增强剂起作用。

Drug development and manufacturing accelerator, Quotient Sciences, has extensive expertise in developing modified release technologies that can transform the drug properties of active compounds otherwise limited by restricted oral bioavailability and/or rapid elimination from the body. These technologies help balance therapeutic needs, manage adverse event profiles, and reduce dosing frequency, which contributes to improved patient compliance and often clinical effectiveness..

药物开发和制造加速器,商科学,在开发可以改变活性化合物的药物性质的改性释放技术方面具有广泛的专业知识,否则受到限制的口服生物利用度和/或从体内快速消除的限制。这些技术有助于平衡治疗需求,管理不良事件概况并减少给药频率,这有助于改善患者依从性和临床效果。。

Quotient Sciences' Translational Pharmaceutics® platform integrates formulation development and real-time manufacturing with clinical testing using an adaptive clinical study design, reducing timelines and costs, and helping to get new medicines to patients faster.

Quotiences的TranslationalPharmaceutics®平台将配方开发和实时制造与临床测试相结合,采用适应性临床研究设计,缩短时间表和成本,并帮助更快地为患者获取新药。

Using Translational Pharmaceutics, the optimized EVX-101 formulation was further validated in Phase 1 single- and multiple-ascending-dose clinical trial in healthy volunteers taking the SSRI escitalopram and demonstrated favorable safety and tolerability, as well as pharmacokinetic and pharmacodynamic data..

使用转化药剂学,优化的EVX-101制剂在服用SSRI依他普仑的健康志愿者的1期单次和多次递增剂量临床试验中得到进一步验证,并证明了有利的安全性和耐受性,以及药代动力学和药效学数据。。

Evecxia will now take the new EVX-101 drug candidate into a Phase 2 adjunctive treatment study in patients with MDD who are responding inadequately to a first-line SSRI/SNRI antidepressant.

Evecxia现在将把新的EVX-101候选药物纳入对一线SSRI/SNRI抗抑郁药反应不足的MDD患者的2期辅助治疗研究。

Commenting on the collaborative work, Jacob Jacobsen, Ph.D., CEO of Evecxia, said: 'Quotient Sciences' expertise in developing and optimizing modified release formulations coupled with their ability to integrate rapid clinical assessments allowed us to produce a new drug candidate, EVX-101, in a highly condensed time frame.' .

Evecxia首席执行官Jacob Jacobsen博士在评论这项合作工作时说:“商科学在开发和优化改良释放制剂方面的专业知识,加上其整合快速临床评估的能力,使我们能够生产出一种新的候选药物,EVX-101,在一个高度浓缩的时间框架内“ .

'We are very pleased with the outcome of this partnership and appreciate the collaboration between both organizations to aid in the advancement of EVX-101 towards helping patients who are suffering from the life-limiting effects of MDD.'

“我们对这种伙伴关系的成果非常满意,并感谢两个组织之间的合作,以帮助推动EVX-101的发展,帮助患有MDD生命限制效应的患者。”

Mark Egerton, Ph.D., CEO of Quotient Sciences, added: 'Our partnership with Evecxia has greatly accelerated the development timeline of their EVX-101 program. Improving mental health is a global goal and the industry must work hard to get treatments to patients more quickly.'

商科学首席执行官Mark Egerton博士补充说:“我们与Evecxia的合作大大加快了EVX-101计划的开发时间表。改善心理健康是一个全球性目标,业界必须努力更快地为患者提供治疗。”

'We are proud that this collaboration and our expertise has enabled Evecxia to successfully progress EVX-101 onward into Phase 2 studies to provide patients who are suffering from MDD with new treatment options.'

“我们很自豪,这次合作和我们的专业知识使Evecxia能够成功地将EVX-101推进到第二阶段研究,为患有MDD的患者提供新的治疗选择。”

About Quotient Sciences

关于商科学

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast.

Quotiences Sciences是一种药物开发和制造加速器,可在整个开发途径中提供综合计划和量身定制的服务。跨越一系列药物开发能力,我们为患者获取药物节省了宝贵的时间和金钱。我们为客户所做的一切都是由一种坚定的信念驱动的,即思想需要成为解决方案,分子需要快速治愈。

Because humanity needs solutions, fast. For more information, please visit quotientsciences.com..

因为人类需要解决方案,所以快速。欲了解更多信息,请访问quotientsciences.com。。

About Evecxia Therapeutics

关于Evecxia疗法

Evecxia's mission is to help patients suffering from disabling neuropsychiatric conditions for which current therapies are inadequate. Evecxia is the first company dedicated to realizing the therapeutic potential of amplifying serotonin synthesis to treat brain disorders.

Evecxia的使命是帮助患有当前治疗不足的神经精神疾病的患者。Evecxia是第一家致力于实现放大血清素合成治疗脑部疾病的治疗潜力的公司。

Serotonin synthesis amplification is distinct from targeting serotonin transporters (e.g., SSRIs) and receptors (e.g., psilocybin). Evecxia deploys 5-HTP, the natural serotonin precursor, delivered via proprietary drug delivery technologies to achieve sustained serotonin synthesis amplification. Evecxia has two Phase 2 clinical-stage drug candidates in development.

5-羟色胺合成扩增不同于靶向5-羟色胺转运蛋白(例如SSRI)和受体(例如裸盖菇素)。Evecxia部署5-HTP,天然5-羟色胺前体,通过专有的药物输送技术提供,以实现持续的5-羟色胺合成扩增。Evecxia有两个2期临床阶段候选药物正在开发中。

EVX-101 is being developed as an adjunctive treatment for depression when first-line SSRI/SNRI antidepressants alone are inadequate. EVX-301 is being developed as a rescue therapy for patients in acute suicidal ideation crises..

当单独的一线SSRI/SNRI抗抑郁药不足时,EVX-101正在开发作为抑郁症的辅助治疗。EVX-301正在开发为急性自杀意念危机患者的救援疗法。。

Evecxia holds a comprehensive portfolio of issued and pending patents on the 5-HTP sustained-release/serotonin amplification method, doses, formulations, and related technologies. For additional information about Evecxia, please visit www.evecxia.com.

Evecxia拥有5-HTP缓释/5-羟色胺扩增方法,剂量,配方和相关技术的已发布和未决专利的全面组合。有关Evecxia的更多信息,请访问www.Evecxia.com。

SOURCE Quotient Sciences

来源商科学