NEW YORK--(BUSINESS WIRE)--Olatec Therapeutics, Inc. (Olatec), a leader in the developing class of selective NLRP3 inhibitors, today announced that Cure Parkinson’s granted an award to initiate a Phase 2 clinical trial investigating the potential of oral dapansutrile to slow or stop the progression of Parkinson’s disease..

纽约--（商业新闻短讯）--开发选择性NLRP3抑制剂的领先者Olatec Therapeutics，Inc.（Olatec）今天宣布，Cure Parkinson's获得了一项奖项，以启动一项2期临床试验，研究口服达潘舒特减缓或阻止帕金森病进展的潜力。。

Parkinson’s is a complex neurodegenerative disease, which as reported by Cure Parkinson’s, is the fastest growing neurological condition in the world. The symptoms of Parkinson’s are treated with a range of medications, but despite decades of research, currently there remains a serious unmet need for a treatment to slow, stop or reverse the progression of this disease..

帕金森氏症是一种复杂的神经退行性疾病，据《治愈帕金森氏症》报道，它是世界上增长最快的神经系统疾病。帕金森氏症的症状用一系列药物治疗，但尽管进行了数十年的研究，但目前仍然存在严重的未满足治疗需求，以减缓，阻止或逆转这种疾病的进展。。

The movement-associated symptoms of Parkinson’s are mainly caused by the loss of dopamine-producing nerve cells (dopaminergic neurons) in the mid-brain called the substantia nigra which controls movement. This loss of dopaminergic neurons is associated with accumulation of a protein known as α-synuclein within neurons, which is thought to disrupt their function.

帕金森氏症的运动相关症状主要是由中脑中产生多巴胺的神经细胞（多巴胺能神经元）的丧失引起的，该神经细胞称为控制运动的黑质。多巴胺能神经元的这种丧失与神经元内一种称为α-突触核蛋白的蛋白质的积累有关，这种蛋白质被认为会破坏其功能。

There is growing scientific literature suggesting that inflammation contributes to the damage and loss of neurons in the brain in Parkinson’s patients. In particular, there is evidence that the NLRP3 inflammasome is activated within the inflammatory cells of the brain, called microglia, and this activation may be triggered by abnormal aggregates of α-synuclein protein.

越来越多的科学文献表明，炎症会导致帕金森病患者大脑神经元的损伤和丢失。特别是，有证据表明NLRP3炎性体在大脑的炎性细胞（称为小胶质细胞）内被激活，这种激活可能是由α-突触核蛋白的异常聚集体触发的。

Treatment with dapansutrile has the potential to arrest this cyclical process of cell damage thereby slowing the progression of the disease..

用达班舒利治疗有可能阻止这种细胞损伤的周期性过程，从而减缓疾病的进展。。

This investigator-initiated study entitled “Anti-inflammatory Intervention with Dapansutrile (OLT1177®) for Parkinson’s Disease Modification (DAPA-PD): A Randomised Double-Blind Placebo-Controlled Phase II Trial” is targeting to commence in mid-2024, subject to completion of all contractual agreements and regulatory authorizations.

这项由研究者发起的研究题为“达班舒利（OLT1177®）对帕金森病改良（DAPA-PD）的抗炎干预：一项随机双盲安慰剂对照II期试验”，目标是在2024年年中开始，但须完成所有合同协议和监管授权。

The trial will seek to enroll 36 participants with early Parkinson’s disease. Treatment duration will be six months with placebo control, followed by an optional, six month open-label phase. This single center study will be conducted at the John van Geest Centre for Brain Repair, Department of Clinical Neurosciences at the University of Cambridge in the UK.

该试验将寻求招募36名早期帕金森病患者。安慰剂对照组的治疗持续时间为六个月，然后是可选的六个月开放标签阶段。这项单中心研究将在英国剑桥大学临床神经科学系约翰·范·吉斯特大脑修复中心进行。

Dr. Caroline H. Williams-Gray, who leads the Cambridge Parkinson’s Disease Research Clinic, is the Principal Investigator..

剑桥帕金森病研究诊所负责人卡罗琳·威廉姆斯·格雷博士是首席研究员。。

When asked about the study, Dr. Caroline Williams-Gray, said: “There is a pressing need for a specific treatment, such as dapansutrile, which targets the most relevant aspects of the immune activation pathway in Parkinson’s without causing general immunosuppression and leading to unwanted side effects.

当被问及这项研究时，卡罗琳·威廉姆斯·格雷博士说：“迫切需要一种特定的治疗方法，例如达潘舒特利，它针对帕金森氏症免疫激活途径中最相关的方面，而不会引起全身免疫抑制并导致不必要的副作用。

In this trial, we aim to determine dapansutrile’s safety and tolerability in patients with Parkinson’s, and to establish whether treatment with dapansutrile can reduce inflammation in both the brain and periphery in Parkinson’s. We will also investigate whether this results in a positive effect on clinical symptoms and disease progression.”.

在这项试验中，我们的目的是确定达潘舒利在帕金森病患者中的安全性和耐受性，并确定达潘舒利治疗是否可以减轻帕金森病患者大脑和外周的炎症。我们还将调查这是否会对临床症状和疾病进展产生积极影响。”。

Olatec’s Founder and CEO, Damaris Skouras commented: “The grant from Cure Parkinson’s and our collaboration with Dr. Williams-Gray at the University of Cambridge provides the possibility to advance dapansutrile in its first CNS indication as a potential disease modifying treatment for Parkinson’s.”

Olatec的创始人兼首席执行官Damaris Skouras评论道：“治愈帕金森氏症的资助以及我们与剑桥大学Williams Gray博士的合作提供了在其第一个中枢神经系统适应症中推进达潘舒特列的可能性，作为帕金森氏症的潜在疾病缓解治疗。”

About Parkinson’s Disease

关于帕金森氏病

Over 9 million people worldwide are living with Parkinson’s disease (mdabstracts.org, 2020). Currently, there are no therapeutics that can alter Parkinson’s disease progression. Patients initially present with complaints of changes in movement, walking and speech; worsening physical symptoms are accompanied by the development of cognitive decline as well as a range of other non-motor symptoms including mood disturbance, bladder and bowel dysfunction, sleep problems and difficulties with blood pressure control.

全世界有900多万人患有帕金森氏病（mdabstracts.org，2020）。目前，没有可以改变帕金森病进展的疗法。患者最初抱怨运动，行走和言语的变化；身体症状恶化伴随着认知能力下降以及一系列其他非运动症状的发展，包括情绪障碍，膀胱和肠道功能障碍，睡眠问题和血压控制困难。

Medications such as levodopa can improve movement symptoms but are unable to control the wide range of non-motor symptoms that affect people with Parkinson’s disease, and do not alter disease progression..

左旋多巴等药物可以改善运动症状，但无法控制影响帕金森病患者的各种非运动症状，也不会改变疾病进展。。

About Scientific Rationale for NLRP3 in Parkinson’s Disease

关于NLRP3在帕金森病中的科学依据

The movement-associated symptoms of Parkinson’s are mainly caused by the loss of dopamine-producing nerve cells (dopaminergic neurons) in an area of the midbrain called the substantia nigra which controls movement. This loss of dopaminergic neurons is associated with accumulation of a protein known as α-synuclein within neurons, which is thought to disrupt their function.

Once around half of the dopaminergic neurons in the substantia nigra are lost, typically the clinical symptoms of Parkinson’s manifest, including slowness of movement, muscle stiffness and tremor. Parkinson’s can also cause a wide range of non-movement related symptoms including anxiety, sleep disturbance, gut symptoms, cognitive problems and dementia.

一旦黑质中大约一半的多巴胺能神经元丢失，通常会出现帕金森氏症的临床症状，包括运动缓慢，肌肉僵硬和震颤。帕金森氏症还可以引起广泛的非运动相关症状，包括焦虑，睡眠障碍，肠道症状，认知问题和痴呆症。

There is growing scientific literature suggesting that inflammation contributes to the damage and loss of neurons in the brain in Parkinson’s. In particular, there is evidence that a complex of proteins called the NLRP3 inflammasome is activated within the inflammatory cells of the brain, called microglia, and this activation may be triggered by abnormal aggregates of α-synuclein protein.

越来越多的科学文献表明，炎症会导致帕金森氏症患者大脑神经元的损伤和丢失。特别是，有证据表明，称为NLRP3炎性体的蛋白质复合物在称为小胶质细胞的大脑炎性细胞内被激活，这种激活可能是由α-突触核蛋白的异常聚集体触发的。

Activation of the NLRP3 inflammasome causes microglia to produce inflammatory molecules which are damaging to dopaminergic neurons, and may promote further α-synuclein aggregation, thus leading to a cyclical process of cell damage. Olatec believes that treatment with dapansutrile has the potential to inhibit the NLRP3 dependent neuroinflammatory process and in so doing arrest this cyclical process of cell damage thereby slowing the progression of the disease..

About Dr. Caroline Williams-Gray, Principal Investigator

关于首席研究员Caroline Williams Gray博士

Dr. Caroline Williams-Gray is a leading clinician scientist specializing in Parkinson’s disease and movement disorders. She studied medicine at Cambridge University and Oxford Clinical School, graduating in 2001, and gained her PhD from Cambridge University in 2008, thereafter training in neurology in Cambridge, Norwich and Queen Square, London.

卡罗琳·威廉姆斯·格雷博士是一位领先的临床科学家，专门研究帕金森氏病和运动障碍。她于2001年毕业于剑桥大学和牛津临床学院学习医学，并于2008年获得剑桥大学博士学位，随后在剑桥、诺里奇和伦敦皇后广场接受神经病学培训。

Dr. Williams-Gray leads the Cambridge Parkinson’s Disease Research Clinic. Dr. Williams-Gray’s work focuses on the theory that the immune system is a significant player in mediating the clinical variability of Parkinson’s disease and its progression; and in particular that peripheral immune activation plays a critical role through exacerbating microglial activation and neuronal damage in the brain..

威廉姆斯·格雷博士领导剑桥帕金森病研究诊所。Williams Gray博士的工作集中在以下理论上：免疫系统在调节帕金森氏病的临床变异性及其进展方面起着重要作用；特别是外周免疫激活通过加剧大脑中的小胶质细胞激活和神经元损伤而发挥关键作用。。

About Cure Parkinson’s

关于治疗帕金森氏症

Cure Parkinson’s, a UK-registered foundation, funds, facilitates and encourages research aiming to find a cure for Parkinson’s, with urgency, for people currently living with Parkinson’s. It was founded in 2005 by people living with Parkinson’s, who set out to find a cure. It focuses on research projects investigating disease-modifying therapies, with the potential to slow, stop or reverse the progression of Parkinson’s.

英国注册基金会“治愈帕金森氏症”资助、促进和鼓励旨在为目前帕金森氏症患者找到治疗帕金森氏症的紧急方法的研究。它是由帕金森病患者于2005年建立的，他们着手寻找治疗方法。它专注于研究疾病缓解疗法的研究项目，这些疗法有可能减缓、阻止或逆转帕金森氏症的进展。

Cure Parkinson’s partners with Van Andel Institute (VAI) and the John Black Charitable Foundation (JBCF) to fund an International Linked Clinical Trials (iLCT) initiative aiming to develop new, potentially disease-modifying Parkinson’s therapies. Together, they have directly funded, or secured funding from donors and fundraisers, for over £75 million supporting clinical trials searching for a cure for Parkinson’s and have pledged a total of USD $6.75 million to Parkinson’s research, over three years.

Cure Parkinson's与Van Andel Institute（VAI）和John Black慈善基金会（JBCF）合作，资助一项国际关联临床试验（iLCT）倡议，旨在开发新的，可能改变疾病的帕金森病疗法。他们共同直接资助或从捐赠者和募捐者那里获得了超过7500万英镑的资金，用于支持寻找帕金森病治疗方法的临床试验，并承诺在三年内为帕金森病研究提供总计675万美元的资金。

Under its iLCT program, Cure Parkinson’s supports clinical trials based on a drug prioritization process conducted by a committee of world-leading experts. Over the last decade, the iLCT program has completed 13 trials and currently has 16 ongoing studies investigating 15 molecules..

根据其iLCT计划，Cure Parkinson's支持由世界领先专家委员会进行的基于药物优先顺序的临床试验。在过去的十年中，iLCT计划已经完成了13项试验，目前有16项正在进行的研究调查了15种分子。。

About Dapansutrile

关于Dapansutrile

Dapansutrile (lab code: OLT1177®) is an investigational small molecule, new chemical entity that specifically binds to and blocks NLRP3 (nucleotide-binding and oligomerization domain [NOD]‑, leucine rich repeat-, pyrin domain-containing 3), the sensor molecule integral in the formation of the NLRP3 inflammasome.

Dapansutrile（实验室代码：OLT1177®）是一种研究性小分子，新的化学实体，可特异性结合并阻断NLRP3（核苷酸结合和寡聚化结构域[NOD]-，富含亮氨酸的重复序列，含有吡啶结构域3），NLRP3炎性体形成过程中不可或缺的传感器分子。

Inflammasomes are multiprotein complexes involved in intracellular surveillance of danger signals that trigger an intense inflammatory response, via generation of bioactive IL-1β and IL-18 through caspase-1 activation. Dapansutrile has been shown to prevent the formation of the NLRP3 inflammasome, which in turn inhibits the production of IL-1β and IL‑18.

炎性体是多蛋白复合物，参与细胞内监测危险信号，通过caspase-1激活产生生物活性IL-1β和IL-18，引发强烈的炎症反应。已显示达潘糖可以阻止NLRP3炎性体的形成，从而抑制IL-1β和IL-18的产生。

Dapansutrile has been well tolerated and shown to improve clinical outcomes in patients with acute gout flare (see The Lancet Rheumatology) and heart failure (see Journal of Cardiovascular Pharmacology). Dapansutrile has also been observed to have anti-inflammatory properties and other promising activity in a broad spectrum of over 20 preclinical animal models including arthritis, asthma, acute myocardial infarction (AMI), heart failure, contact dermatitis, multiple sclerosis, melanoma, pancreatic and breast cancers, spinal cord injury (SCI), Parkinson’s and Alzheimer’s disease.

达潘舒特耐受性良好，可改善急性痛风发作（见柳叶刀风湿病）和心力衰竭（见心血管药理学杂志）患者的临床结局。在包括关节炎、哮喘、急性心肌梗死（AMI）、心力衰竭、接触性皮炎、多发性硬化症、黑色素瘤、胰腺癌和乳腺癌、脊髓损伤（SCI）、帕金森病和阿尔茨海默病在内的20多种临床前动物模型中，达潘苏特列也被观察到具有抗炎特性和其他有希望的活性。

For a complete list of Olatec’s original publications on dapansutrile in various preclinical and clinical disease areas, please refer to Olatec’s publication page, here..

有关Olatec在各种临床前和临床疾病领域关于达潘苏特利的原始出版物的完整列表，请参阅此处的Olatec出版物页面。。

About Olatec Therapeutics, Inc.

关于Olatec Therapeutics，Inc。

Olatec is a privately held, clinical-stage biopharmaceutical company developing a platform of oral NLRP3 inhibitors to treat and prevent a broad spectrum of acute and chronic inflammatory diseases known to be mediated by IL-1. Clinical trials include gout and diseases of aging such as type 2 diabetes, heart failure and cancer (see list of clinical trials to-date, here).

Olatec是一家私营的临床阶段生物制药公司，开发了一种口服NLRP3抑制剂平台，用于治疗和预防已知由IL-1介导的广泛急性和慢性炎症性疾病。临床试验包括痛风和衰老疾病，如2型糖尿病、心力衰竭和癌症（请参阅迄今为止的临床试验清单）。

In addition to the lead compound, dapansutrile, Olatec’s platform of proprietary compounds includes approximately 40 analogues (OLT Analogues) being screened as viable drug candidates. A portfolio of intellectual property registrations protecting Olatec’s compounds consists of over 150 patents granted.

除了先导化合物dapansutrile之外，Olatec的专有化合物平台还包括大约40种类似物（OLT类似物）被筛选为可行的候选药物。保护Olatec化合物的知识产权注册组合包括150多项授予的专利。

Olatec’s drug development team is comprised of experienced management and international experts in translational medicine with unparalleled expertise in inflammation and immunology and has been involved in the discovery and development of first-line inflammation treatments in the market today. For more information, please visit http://www.olatec.com.

Olatec的药物开发团队由经验丰富的管理人员和国际转化医学专家组成，在炎症和免疫学方面具有无与伦比的专业知识，并参与了当今市场上一线炎症治疗的发现和开发。有关更多信息，请访问http://www.olatec.com.

Disclaimer & Forward-looking Statement

免责声明和前瞻性声明

This press release is not an offer to sell and is not soliciting an offer to buy any equity interests in the Company. The information contained herein is being provided for information purposes only. The Company makes no express or implied representation or warranty as to the completeness of this information.

本新闻稿不是出售要约，也不是征求购买公司任何股权的要约。此处包含的信息仅供参考。本公司对本信息的完整性不作任何明示或暗示的陈述或保证。

Any forward-looking statements contained in this release are based on assumptions made by Olatec at the time this Press Release was prepared. Any forward-looking statement contained in this Press Release is subject to known and unknown risks, uncertainties and other factors that may be materially different from those contemplated in such forward-looking statements.

本新闻稿中包含的任何前瞻性声明均基于OLETC在编写本新闻稿时所做的假设。本新闻稿中包含的任何前瞻性声明都会受到已知和未知风险、不确定性和其他因素的影响，这些因素可能与此类前瞻性声明中预期的因素存在重大差异。

All information with respect to industry data has been obtained from sources believed to be reliable and current, but the accuracy thereof cannot be guaranteed by the Company. Olatec does not undertake any obligation to update or revise the forward-looking statements contained in this Press Release to reflect events or circumstances occurring after the date this Press Release was prepared, or to reflect the occurrence of unanticipated events..

有关行业数据的所有信息均来自可靠且最新的来源，但公司无法保证其准确性。OLETC没有义务更新或修改本新闻稿中包含的前瞻性声明，以反映本新闻稿编制日期后发生的事件或情况，或反映意外事件的发生。。