SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology designed to leverage a patient’s own biology to deliver rare disease therapeutics, today announced that the first patient has been dosed in the company’s Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T) clinical trial to evaluate the neurological effects of EryDex in patients with Ataxia-Telangiectasia (A-T).

加利福尼亚州南旧金山（商业新闻短讯）--Quince Therapeutics，Inc.（纳斯达克：QNCX），一家开发创新药物递送技术的晚期生物技术公司，旨在利用患者自身的生物学特性来提供罕见疾病治疗剂，今天宣布，该公司的第三阶段NEAT（EryDex对a-T受试者的神经系统影响）临床试验中，第一名患者已服用该药物，以评估EryDex对共济失调毛细血管扩张症（a-T）患者的神经系统影响。

This pivotal Phase 3 study will be conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food & Drug Administration (FDA)..

这项关键的第三阶段研究将根据与美国食品和药物管理局（FDA）签订的特别协议评估（SPA）协议进行。。

“The initiation of our pivotal Phase 3 NEAT study is a major milestone for Quince, and an opportunity for patients living with the devastating effects of Ataxia-Telangiectasia to participate in research seeking to identify a beneficial therapeutic solution,” said Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer.

昆斯首席执行官兼首席医疗官德克·塞耶（Dirk Thye）医学博士说：“我们关键的第三阶段NEAT研究的启动是昆斯的一个重要里程碑，也是患有共济失调毛细血管扩张症破坏性影响的患者参与寻求有益治疗方案的研究的机会。”。

“There are currently no approved therapeutic treatments in any global market for this rare pediatric disease, and our primary corporate objective is to change that for patients with A-T and their families.”.

“目前，在全球任何市场上都没有针对这种罕见儿科疾病的经批准的治疗方法，我们的主要公司目标是改变A-T患者及其家属的治疗方法。”。

The Phase 3 NEAT clinical trial (#IEDAT-04-2022/NCT06193200) is an international, multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of EryDex in patients with A-T. The study plans to enroll approximately 86 patients with A-T ages six to nine years old (primary analysis population) and approximately 20 patients with A-T ages 10 years or older.

第三阶段NEAT临床试验（#IEDAT-04-2022/NCT06193200）是一项国际性，多中心，随机，双盲，安慰剂对照的临床试验，用于评估EryDex对A-T患者的神经系统影响。该研究计划招募大约86名6至9岁的A-T患者（主要分析人群）和大约20名10岁或以上的A-T患者。

Participants will be randomized (1:1) between EryDex or placebo and treatment will consist of six infusions scheduled every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last visit completion in rescored modified International Cooperative Ataxia Rating Scale (RmICARS).

参与者将在EryDex或安慰剂之间随机（1:1），治疗将包括每21至30天安排六次输注。主要疗效终点将通过重新评分的改良国际合作共济失调评定量表（RmICARS）从基线到最后一次就诊完成的变化来衡量。

Participants who complete the full treatment period, complete the study assessments, and provide informed consent will be eligible to transition to an open label extension (OLE) study. Quince expects to report Phase 3 NEAT topline results in the second half of 2025 with a potential New Drug Application (NDA) submission in 2026, assuming positive study results..

完成完整治疗期，完成研究评估并提供知情同意的参与者将有资格过渡到开放标签扩展（OLE）研究。Quince预计在2025年下半年报告第三阶段整洁的topline结果，并在2026年提交潜在的新药申请（NDA），假设研究结果为阳性。。

With the achievement of the first patient enrolled in this study, Quince will make a cash milestone payment of $5 million to the former EryDel shareholders. The company owes no further development related milestones to EryDel shareholders.

随着第一位参与这项研究的患者的成功，昆斯将向前埃尔德尔股东支付500万美元的现金里程碑付款。该公司不欠EryDel股东更多与发展相关的里程碑。

About Ataxia-Telangiectasia

关于共济失调毛细血管扩张

A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency.

A-T是由ATM基因突变引起的遗传性常染色体隐性神经退行性疾病和免疫缺陷疾病，负责细胞稳态和细胞分裂功能，包括但不限于双链DNA修复。通常，A-T首先在五岁之前被诊断出来，因为儿童开始改变步态并以更高的频率跌倒。

Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy.

。A-T患者的青少年时期通常以反复感染，肺损伤和恶性肿瘤为特征。中位寿命约为25至30岁，因感染和恶性肿瘤而死亡。

Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the U.S. Quince estimates that there are approximately 5,000 patients with A-T in the U.K. and EU4 countries. There are currently no approved therapeutic treatments in any global market for A-T..

根据IQVIA Medical Claims（Dx），PharmetricsPlus（P+）和IQVIA Analytics信息，美国约有4600名确诊的A-T患者。Quince估计，英国和欧盟4个国家约有5000名A-T患者。目前，全球任何A-T市场都没有批准的治疗方法。。

About EryDex for A-T

关于A-T的EryDex

EryDex is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient’s own red blood cells. DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. EryDex is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment..

EryDex由包裹在患者自身红细胞中的地塞米松磷酸钠（DSP）组成。DSP是一种皮质类固醇，因其抗炎特性以及肾上腺抑制引起的剂量限制性毒性而闻名。EryDex旨在提供皮质类固醇的功效，并减少或消除长期使用皮质类固醇治疗带来的重大不良反应。。

EryDex leverages Quince’s proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient’s own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life.

EryDex利用Quince专有的自体细胞内药物封装或AIDE技术平台，这是一种新型药物/设备组合，使用自动化过程将药物封装到患者自己的红细胞中。红细胞具有几个特征，使其成为药物递送的潜在有效载体，包括潜在更好的耐受性，增强的组织分布，降低的免疫原性和延长循环半衰期。

Quince’s AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response..

Quince的AIDE技术旨在利用这些优势，允许长期服用由于毒性，生物分布不良，药代动力学不理想或免疫反应而受到限制的药物。。

About Quince Therapeutics

关于Quince Therapeutics

Quince Therapeutics (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the potential of a patient’s own biology to deliver innovative and life-changing therapeutics to those living with rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince Therapeutics on social media platforms LinkedIn, Facebook, and Twitter/X..

Quince Therapeutics（纳斯达克股票代码：QNCX）是一家晚期生物技术公司，致力于挖掘患者自身生物学的潜力，为患有罕见疾病的患者提供创新和改变生命的疗法。有关该公司及其最新消息的更多信息，请访问www.quincetx.com，并在社交媒体平台LinkedIn、Facebook和Twitter/X上关注Quince Therapeutics。。

Forward-looking Statements

前瞻性声明

Statements in this news release contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections.

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All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as “believe,” “may,” “should,” “expect,” “anticipate,” “plan,” “believe,” “estimated,” “potential,” “intend,” “will,” “can,” “seek,” or other similar words.

除历史事实陈述外，所有陈述都可能是前瞻性陈述。本新闻稿中包含的前瞻性陈述可以通过使用“相信”、“可能”、“应该”、“期望”、“预期”、“计划”、“相信”、“估计”、“潜在”、“打算”、“将会”、“可以”、“寻求”或其他类似词语来识别。

Examples of forward-looking statements include, among others, statements relating to current and future clinical development of EryDex, including a pivotal trial for Ataxia-Telangiectasia, potential commercial-stage inflection point for EryDex, and expansion of the company’s proprietary Autologous Intracellular Drug Encapsulation (AIDE) technology for treatment of other rare diseases; the strategic development path for EryDex; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; the timing and success of the clinical trials and related data, including plans and the ability to initiate, conduct, and/or complete current and additional studies; the company’s future development plans and related timing; the company’s focus, objectives, plans, and strategies; and the company’s market opportunity.

前瞻性声明的例子包括与EryDex当前和未来临床开发有关的声明，包括共济失调毛细血管扩张的关键试验，EryDex潜在的商业阶段拐点，以及公司专有自体细胞内药物包封（AIDE）技术的扩展，用于治疗其他罕见疾病；EryDex的战略发展路径；计划的监管机构提交和临床试验以及时间表，前景和里程碑预期；；公司未来发展计划及相关时间安排；公司的重点、目标、计划和战略；以及公司的市场机会。

Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the compan.

前瞻性陈述基于Quince当前的预期，并受到难以预测的固有不确定性、风险和假设的影响，并可能导致实际结果与公司的实际结果产生重大差异。