– Company completes dosing of first and second cohorts in Phase 1 clinical trial, ENTR-601-44-101 –

-公司在第一阶段临床试验ENTR-601-44-101中完成第一组和第二组的剂量

– ENTR-601-44 clinical development program remains on track with data readout expected in second half of 2024 –

–ENTR-601-44临床开发计划仍在跟踪中，预计2024年下半年将读取数据–

– U.S. FDA clinical hold on IND application remains in effect –

-美国FDA对IND申请的临床持有仍然有效–

– Cash runway expected through 2025 –

-预计到2025年的现金跑道-

BOSTON, Nov. 22, 2023 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA), a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new class of medicines, today announced the completion of dosing for the first and second cohorts of its Phase 1 clinical trial, ENTR-601-44-101.

2023年11月22日，波士顿（GLOBE NEWSWIRE）-Entrada Therapeutics，Inc.（纳斯达克股票代码：TRDA），一家临床阶段的生物制药公司，旨在通过建立细胞内内体逃逸载体（EEV）来改变患者的生活™)-therapeutics作为一类新药物，今天宣布完成其1期临床试验ENTR-601-44-101的第一和第二队列的给药。

Entrada plans to announce data from ENTR-601-44-101 in the second half of 2024..

Entrada计划在2024年下半年公布ENTR-601-44-101的数据。。

“Our strategy has always been to run a single Phase 1 clinical trial for ENTR-601-44 and, notably, that trial is progressing in the United Kingdom. We are pleased to have completed dosing of the first and second cohorts of participants,” said Dipal Doshi, President and Chief Executive Officer at Entrada Therapeutics.

“我们的策略一直是为ENTR-601-44进行单一的1期临床试验，特别是该试验正在英国进行，我们很高兴已经完成了第一批和第二批参与者的剂量，”Entrada Therapeutics总裁兼首席执行官Dipal Doshi说。

“In parallel with the Phase 1 clinical trial, we continue to plan for the global development of ENTR-601-44 which will include clinical trials in patients with Duchenne who are exon 44 skipping amenable.”.

“在第一阶段临床试验的同时，我们继续计划ENTR-601-44的全球发展，其中将包括Duchenne患者的临床试验，这些患者的第44外显子可以跳过。

The primary objective of Entrada’s double-blind, single ascending dose Phase 1 clinical trial, which is expected to enroll approximately 40 participants, is to evaluate the safety and tolerability of a single dose of ENTR-601-44 in healthy male volunteers. ENTR-601-44-101 will also evaluate pharmacokinetics and target engagement, as measured by exon skipping in the skeletal muscle..

Entrada的双盲，单次递增剂量1期临床试验的主要目标是评估单剂量ENTR-601-44在健康男性志愿者中的安全性和耐受性。ENTR-601-44-101还将评估药代动力学和靶标参与度，通过骨骼肌中外显子跳跃来衡量。。

Update on ENTR-601-44 Investigational New Drug (IND) Application

ENTR-601-44研究性新药（IND）申请更新

Entrada was previously notified by the FDA that the IND for the Phase 1 clinical trial of ENTR-601-44 had been placed on clinical hold. Despite providing additional information to the FDA, the Company was informed that the Agency declined to lift the clinical hold. Importantly, the information that was submitted to the FDA supported the initiation of the Phase 1 clinical trial in the United Kingdom in September 2023..

Entrada之前已被FDA通知ENTR-601-44的1期临床试验的IND已被临床搁置。尽管向FDA提供了更多信息，但该公司被告知该机构拒绝提升临床保留。重要的是，提交给FDA的信息支持2023年9月在英国启动1期临床试验。。

“We are disappointed that the U.S. clinical hold has not been lifted, especially given the strength of the data package submitted to the FDA. It’s important to emphasize that the ongoing ENTR-601-44 development program continues to progress, with ENTR-601-44-101 clinical data expected in the second half of 2024.

“我们感到失望的是，美国的临床保留尚未取消，特别是考虑到提交给FDA的数据包的强度，重要的是要强调正在进行的ENTR-601-44开发计划继续取得进展，ENTR-601-44-101临床数据预计在2024年下半年。

We will re-engage the FDA to discuss next steps in due course,” concluded Mr. Doshi..

Doshi先生总结说，我们将重新聘请FDA在适当的时候讨论下一步。。

About ENTR-601-44

关于ENTR-601-44

ENTR-601-44, a proprietary Endosomal Escape Vehicle (EEV™)-conjugated phosphorodiamidate morpholino oligomer (PMO), is the lead product candidate within Entrada’s Duchenne muscular dystrophy franchise from its growing pipeline of EEV-therapeutics. Each EEV-PMO therapeutic candidate has an oligonucleotide sequence designed and optimized for the specific subpopulation of interest.

ENTR-601-44，专有的内体逃逸载体（EEV™)-共轭磷二酰胺吗啉代低聚物（PMO）是Entrada从其不断增长的EEV therapeutics渠道经营的Duchenne肌营养不良症特许经营权中的主要候选产品。每个EEV-PMO治疗候选物具有针对感兴趣的特定亚群设计和优化的寡核苷酸序列。

ENTR-601-44 is designed to address the underlying cause of Duchenne due to mutated or missing exons in the DMD gene. ENTR-601-44, an investigational therapy for the potential treatment of people living with Duchenne who are exon 44 skipping amenable, is being evaluated for its potential to restore the mRNA reading frame and allow for the translation of dystrophin protein that is slightly shortened but still functional..

ENTR-601-44旨在解决DMD基因中外显子突变或缺失导致Duchenne的根本原因。ENTR-601-44是一项研究性疗法，用于治疗Duchenne患者的潜在治疗方法，他们的第44外显子可以跳过，目前正在评估其恢复mRNA阅读框架的潜力，并允许肌营养不良蛋白的翻译，这种翻译稍微缩短但仍然有功能。。

About Entrada Therapeutics

关于Entrada疗法

Entrada Therapeutics is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines, Endosomal Escape Vehicle (EEV™)-therapeutics, to engage intracellular targets that have long been considered inaccessible and undruggable. The Company’s EEV therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index.

Entrada Therapeutics是一家临床阶段的生物制药公司，旨在通过建立一类新的药物-内体逃逸载体（EEV）来改变患者的生活™)-治疗学，以参与长期以来被认为难以接近和不可摧毁的细胞内靶标。该公司的EEV therapeutics旨在使多种治疗剂有效地细胞内递送到各种器官和组织中，从而提高治疗指数。

Through its proprietary, highly versatile and modular EEV platform, Entrada is building a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, immunological, ocular and metabolic diseases, among others. The Company’s lead oligonucleotide programs include ENTR-601-44, ENTR-601-45 and ENTR-601-50 for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable, respectively, as well as our partnered candidate ENTR-701 for myotonic dystrophy type 1..

通过其专有的，高度通用的模块化EEV平台，Entrada正在建立一个强大的基于RNA，抗体和酶的程序开发组合，用于潜在治疗神经肌肉，免疫，眼部和代谢疾病等。该公司的主要寡核苷酸项目包括ENTR-601-44，ENTR-601-45和ENTR-601-50，用于分别治疗Duchenne外显子44,45和50可跳过的人，以及我们的合作候选人ENTR-701用于1型肌强直性营养不良。。

For more information about Entrada, please visit our website, www.entradatx.com, and follow us on LinkedIn.

有关Entrada的更多信息，请访问我们的网站www.entradatx.com，并在LinkedIn上关注我们。

Forward-Looking Statements

前瞻性声明

This news release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this news release, including statements regarding Entrada’s strategy, future operations, prospects and plans, objectives of management, Entrada’s ability to continue to recruit for and complete its ENTR-601-44-101 Phase 1 clinical trial in the United Kingdom, expectations regarding the announcement of data from its ENTR-601-44-101 clinical trial in the second half of 2024, express or implied statements regarding the clinical hold on the IND for ENTR-601-44, Entrada’s ability to address the FDA’s concerns regarding ENTR-601-44, Entrada’s ability to initiate and recruit for potential global clinical trials for ENTR-601-44 in patients with Duchenne muscular dystrophy (DMD) who are exon 44 skipping amenable, expectations regarding the safety and therapeutic benefits of ENTR-601-44, the continued development and advancement of ENTR-601-44, ENTR-601-45 and ENTR-601-50 for the treatment of DMD, and ENTR-701 for the treatment of myotonic dystrophy type 1 (DM1), the ability to develop additional therapeutic programs, including further exon skipping programs, the potential therapeutic benefits of its EEV candidates, and the sufficiency of its cash resources through 2025, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.

本新闻稿包含涉及重大风险和不确定性的前瞻性声明。本新闻稿中包含的所有陈述，除历史事实陈述外，包括有关Entrada战略，未来运营，前景和计划，管理目标，Entrada继续招募并完成其ENTR-601-44-101的能力的陈述。英国的1期临床试验，对2024年下半年ENTR-601-44-101临床试验数据公布的期望，关于ENTR-601-44 IND临床保留的明示或暗示声明，Entrada能够解决FDA的担忧关于ENTR-601-44，Entrada能够启动和招募ENTR-601-44潜在的全球临床试验，用于Duchenne型肌营养不良症（DMD）患者，他们是外显子44跳过顺从的，对ENTR-601-44的安全性和治疗益处的期望，ENTR-601-44，ENTR-601-45和ENTR-601-50用于治疗DMD的持续发展和进步，和ENTR-701治疗肌强直性营养不良1型（DM1），开发额外治疗方案的能力，包括进一步的外显子跳跃方案，其EEV候选人的潜在治疗益处，以及到2025年其现金资源的充足性，构成1995年“私人证券诉讼改革法”含义内的前瞻性陈述。

The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all for.

“预期”，“相信”，“继续”，“可以”，“估计”，“期望”，“意图”，“可以”，“可能”，“客观”，“正在进行”，“计划”，“预测”，“项目”，“潜力”，“应该”或“将会”或这些术语或其他可比较的术语的否定之处旨在确定前瞻性陈述，尽管并非全部。

Investor and Media Contact

投资者和媒体联系

Karla MacDonald

卡拉·麦克唐纳

Chief Corporate Affairs Officer

首席公司事务官员

kmacdonald@entradatx.com

kmacdonald@entradatx.com