BASEL, Switzerland, April 22, 2025 / Biotech Newswire / --

瑞士巴塞尔，2025年4月22日 /生物技术新闻社/ --

EsoCap AG

埃索卡普股份公司

today announced the highly anticipated presentation of data from the ACESO Phase II study at Digestive Disease Week (DDW) 2025, taking place May 3–6 in San Diego, USA. The oral presentation, delivered by Prof. Evan Dellon of the University of North Carolina at Chapel Hill, will highlight key findings on the safety, adherence, and satisfaction associated with EsoCap’s novel drug delivery system for eosinophilic esophagitis (EoE).

今天宣布了在2025年5月3日至6日于美国圣地亚哥举行的消化疾病周（DDW）上，备受期待的ACESO二期研究数据的展示。北卡罗来纳大学教堂山分校的埃文·德拉隆教授将进行口头报告，重点介绍与EsoCap用于嗜酸性食管炎（EoE）的新型药物递送系统相关的安全性、依从性和满意度的关键发现。

This presentation is scheduled for May 3, 2025, from 4:00 to 5:30 pm in the session titled “What’s New in Eosinophilic Esophagitis?”.

本次演讲计划于 2025 年 5 月 3 日下午 4:00 至 5:30，在题为“嗜酸性食管炎的新进展”的会议中进行。

Advancing Targeted Therapies for EoE with ESO-101

通过ESO-101推进EoE的靶向治疗

EoE is a chronic, immune-mediated esophageal disease marked by debilitating symptoms such as dysphagia (difficulty swallowing), food impaction, heartburn, and vomiting. The ACESO study, a randomized, placebo-controlled, double-blind Phase II clinical trial, evaluated the safety, tolerability, and efficacy of ESO-101—EsoCap’s innovative esophageal drug delivery system featuring a mucoadhesive film containing the anti-inflammatory corticosteroid mometasone furoate..

EoE是一种慢性免疫介导的食管疾病，其特征是出现诸如吞咽困难、食物嵌塞、胃灼热和呕吐等令人虚弱的症状。ACESO研究是一项随机、安慰剂对照、双盲的II期临床试验，评估了ESO-101的安全性、耐受性和有效性。ESO-101是EsoCap公司创新的食管药物递送系统，包含一种含有抗炎皮质类固醇糠酸莫米松的粘膜粘附薄膜。

Conducted at 14 medical centers across five European countries, the trial enrolled 43 adult patients with active EoE (≥15 eosinophils per high-power field). Participants were randomized in a 2:1 ratio to receive ESO-101 or placebo once daily for 28 days.

在欧洲五个国家的14个医疗中心进行的试验中，纳入了43名活动性嗜酸性食管炎（每高倍视野≥15个嗜酸性粒细胞）的成年患者。参与者以2:1的比例随机分配，接受ESO-101或安慰剂，每日一次，持续28天。

Compelling Clinical Outcomes

引人注目的临床结果

The ACESO trial met its primary endpoint, demonstrating a statistically significant reduction in peak eosinophil counts from baseline. ESO-101 achieved a mean reduction of 49.1 ± 88.4 eosinophils/hpf (p=0.0318). Notably, while no patients in the placebo group reached histological remission, 48% and 44% of those receiving ESO-101 achieved <15 and <6 eosinophils/hpf, respectively (p=0.0028 and p=0.0035)..

ACESO 试验达到了主要终点，显示出与基线相比嗜酸性粒细胞峰值计数的统计学显著降低。ESO-101 实现了平均减少 49.1 ± 88.4 个嗜酸性粒细胞/hpf（p=0.0318）。值得注意的是，安慰剂组中无患者达到组织学缓解，而接受 ESO-101 的患者中分别有 48% 和 44% 达到 <15 和 <6 个嗜酸性粒细胞/hpf（p=0.0028 和 p=0.0035）。

Furthermore, ESO-101 treatment yielded significant reductions in eosinophilic esophagitis endoscopic reference scores (EREFS), suggesting a promising remodeling effect on esophageal tissue. Despite a short 28-day treatment period, ESO-101 also demonstrated a meaningful improvement in dysphagia symptoms, supporting its potential for long-term efficacy in future trials(1)..

此外，ESO-101 治疗显著降低了嗜酸性食管炎内镜参考评分 (EREFS)，表明其对食管组织具有良好的重塑作用。尽管治疗周期仅为 28 天，ESO-101 仍显示出吞咽困难症状的显著改善，为其在未来的长期疗效试验中提供了支持(1)。

Exceptional Safety, Adherence, and Patient Satisfaction

卓越的安全性、依从性和患者满意度

Critically, ESO-101 exhibited an outstanding safety and tolerability profile, with no cases of oral, oropharyngeal, or esophageal candidiasis—common adverse effects associated with topical corticosteroid treatments. Patient compliance was remarkably high at 100% in the ESO-101 group and 93% in the placebo group.

关键的是，ESO-101表现出卓越的安全性和耐受性，没有出现口腔、口咽或食道念珠菌病的病例——这些是与局部皮质类固醇治疗相关的常见不良反应。ESO-101组患者依从性高达100%，而安慰剂组为93%。

Additionally, patient-reported satisfaction underscored the ease of use and user-friendly design of the ESO-101 delivery system. Overall, a majority of patients reported being satisfied or very satisfied, with 85% in the ESO-101 group and 75% in the placebo group, based on responses to all questionnaire items..

此外，患者报告的满意度强调了ESO-101递送系统的易用性和用户友好的设计。总体而言，大多数患者报告感到满意或非常满意，其中ESO-101组有85%，安慰剂组有75%，这是基于对所有问卷项目的回答。

“The ACESO trial provides compelling evidence of ESO-101’s ability to deliver sustained, targeted therapy directly to the esophageal mucosa,”

“ACESO 试验提供了令人信服的证据，证明 ESO-101 能够将持续、靶向的治疗直接递送到食管黏膜。”

said Prof. Evan Dellon, University of North Carolina at Chapel Hill, USA.

美国北卡罗来纳大学教堂山分校的埃文·戴隆教授说。

“These results highlight its potential as a breakthrough treatment in EoE, leading to a high adherence with a user-friendly drug delivery system.”

“这些结果突显了它作为EoE突破性治疗的潜力，得益于用户友好的药物递送系统，具有很高的依从性。”

Isabelle Racamier, CEO of EsoCap, expressed enthusiasm for the study’s impact:

EsoCap首席执行官伊莎贝尔·拉卡米埃对这项研究的影响表示热情：

“We are thrilled that the ACESO Phase II clinical data will be showcased at DDW 2025 by Prof. Dr. Evan Dellon, a leading expert in EoE research. The significant reduction in peak eosinophil count, coupled with ESO-101’s excellent safety, adherence, and patient satisfaction, marks a major milestone in the advancement of esophageal drug delivery.”.

“我们非常高兴ACESO二期临床数据将由嗜酸性食管炎研究领域的权威专家埃文·德拉顿教授在2025年DDW会议上展示。峰值嗜酸性粒细胞计数显著减少，加上ESO-101出色的安全性、依从性和患者满意度，标志着食管药物递送领域的一个重要里程碑。”

About eosinophilic esophagitis

关于嗜酸性食管炎

Eosinophilic esophagitis (EoE) is an increasingly recognized, chronic, local immune-mediated esophageal disease, characterized clinically by symptoms related to esophageal dysfunction and histologically by eosinophil-predominant inflammation. The symptoms of EoE include swallowing disorders, food impaction, vomiting, and heartburn.

嗜酸性粒细胞性食管炎（EoE）是一种日益受到关注的慢性局部免疫介导的食管疾病，临床上以食管功能障碍相关症状为特征，组织学上表现为以嗜酸性粒细胞为主的炎症。EoE的症状包括吞咽障碍、食物嵌顿、呕吐和烧心。

EoE is the leading cause of dysphagia and food impaction in children and young adults..

嗜酸性食管炎是导致儿童和年轻人吞咽困难和食物嵌塞的主要原因。

The only treatment options for the condition are extremely strict diets, off-label treatment with steroids or proton pump inhibitors, an orodispersible budesonide tablet available only in limited territories, or an oral suspension of budesonide approved exclusively in the USA for a short treatment duration.

该疾病唯一的治疗选择包括极其严格的饮食、标签外使用的类固醇或质子泵抑制剂、仅在有限地区可用的口腔分散型布地奈德片剂，或仅在美国获批用于短期治疗的布地奈德口服混悬液。

These treatment options remain suboptimal for the vast majority of affected patients. A monoclonal antibody targeting Th2 cell-released cytokines such as interleukin-4 (IL-4) and interleukin-13 (IL-13) was approved to treat EoE globally for steroid resistant patients. Currently, about 500,000 patients worldwide suffer from this disease.

这些治疗选项对于绝大多数受影响的患者来说仍然不够理想。一种针对 Th2 细胞释放的细胞因子（如白介素-4 (IL-4) 和白介素-13 (IL-13)）的单克隆抗体已被批准用于全球类固醇抵抗性嗜酸性食管炎 (EoE) 患者的治疗。目前，全球约有 50 万名患者受此疾病困扰。

The prevalence of EoE is over 6 in 10,000. The current incidence is estimated to exceed 5 cases per 100,000. The incidence of EoE increases with age and peaks at 30-50 years of age..

EoE的患病率超过万分之六，当前发病率估计超过每10万人5例。EoE的发病率随年龄增长而增加，并在30-50岁之间达到高峰。

About the ACESO Phase II trial

关于ACESO二期试验

The ACESO trial was a multicenter, randomized, double-blinded, placebo-controlled clinical Phase II trial evaluating the efficacy, tolerability, and safety of ESO-101 in adult patients with active EoE. Patients were treated once daily for 28 days.

ACESO 试验是一项多中心、随机、双盲、安慰剂对照的 II 期临床试验，评估了 ESO-101 在活动性嗜酸性食管炎成年患者中的疗效、耐受性和安全性。患者每日一次接受治疗，持续 28 天。

The trial’s primary objective was to evaluate efficacy based on histological response. Secondary objectives included efficacy based on 1) histological response and clinical symptoms, 2) clinical response assessed by patient-reported outcomes, and 3) endoscopic response; patient-reported treatment satisfaction; as well as evaluation of tolerability and safety..

该试验的主要目的是基于组织学反应评估疗效。次要目的包括基于以下方面的疗效：1）组织学反应和临床症状，2）由患者报告结果评估的临床反应，3）内镜反应；患者报告的治疗满意度；以及对耐受性和安全性的评估。

About ESO-101

关于ESO-101

The EsoCap system is a unique drug delivery system for the upper gastrointestinal tract, consisting of a capsule holder containing a hard gelatin capsule, with a rolled, thin mucoadhesive film, a sinker, and a soluble retainer. The capsule holder is screwed onto the lid of a drinking cup to facilitate swallowing while drinking from the cup.

EsoCap系统是一种独特的上消化道给药系统，由一个含有硬明胶胶囊的胶囊支架组成，胶囊内含卷起的薄型粘膜粘附膜、沉降器和可溶性固定器。胶囊支架旋紧在饮水杯的杯盖上，以便在饮水时帮助吞咽。

Upon swallowing, the film unrolls and sticks to the esophageal mucosa, where it dissolves, with a contact time of 15 minutes(1,2), significantly longer than the mucosal contact time of pharmaceutical dosage forms, such as orodispersible tablets (less than one minute)(4)..

吞咽后，薄膜展开并粘附在食道粘膜上，溶解时间长达15分钟(1,2)，显著长于药物剂型（如口崩片）与粘膜接触的时间（不到一分钟）(4)。

The use of mometasone furoate as a swallowed aerosol formulation has been studied previously in several trials assessing its effect on EoE in adults. In these trials, mometasone furoate was shown to significantly decrease esophageal eosinophilic inflammation and improve clinical symptoms.

之前已有数项试验研究了糠酸莫米松作为吸入型气雾剂对成人嗜酸性粒细胞性食管炎 (EoE) 的影响。在这些试验中，糠酸莫米松被证明能显著减轻食管嗜酸性炎症并改善临床症状。

ESO-101 was designed as a locoregional, esophagus-adjusted drug formulation and novel delivery system to optimize mucosal contact time and maximize esophageal deposition of mometasone furoate. ESO-101 has the potential to provide significant clinical benefits to EoE patients.

ESO-101 被设计为一种局部区域、针对食管调整的药物配方和新型递送系统，以优化粘膜接触时间并最大化糠酸莫米松在食管中的沉积。ESO-101 有可能为嗜酸性粒细胞性食管炎 (EoE) 患者提供显著的临床益处。

About

关于

EsoCap

EsoCap

EsoCap AG, a privately funded company based in Basel, Switzerland, has developed a breakthrough targeted drug delivery platform for upper gastrointestinal diseases. Conventional esophageal treatments are hindered by an ultra-short drug contact time of just 45 seconds. EsoCap’s innovative technology overcomes this limitation, enabling prolonged mucosal contact and controlled drug release—key factors in enhancing treatment efficacy and patient outcomes..

EsoCap AG是一家总部位于瑞士巴塞尔的私人资助公司，开发了一种用于上消化道疾病的突破性靶向药物递送平台。传统的食管治疗受到仅45秒的超短药物接触时间的限制。EsoCap的创新技术克服了这一局限性，实现了延长的黏膜接触和可控的药物释放，这是提升治疗效果和患者预后的关键因素。

The Phase II ACESO study, a double-blind, randomized, placebo-controlled trial conducted across five countries, demonstrated that ESO-101, paired with mometasone, achieved a statistically significant reduction in peak eosinophil counts (p=0.0318) in eosinophilic esophagitis (EoE). Additionally, 48% and 44% of patients achieved <15 and <6 eosinophils/hpf, respectively (p=0.0028 and p=0.0035), with an excellent safety profile—most notably, no cases of candidiasis..

第二阶段的ACESO研究是一项在五个国家进行的双盲、随机、安慰剂对照试验，结果显示，ESO-101与莫米松联合使用，在嗜酸性粒细胞性食管炎（EoE）中显著降低了嗜酸性粒细胞峰值计数（p=0.0318）。此外，分别有48%和44%的患者达到了<15和<6个嗜酸性粒细胞/高倍视野（hpf）的目标（p=0.0028和p=0.0035），且安全性表现优异——最显著的是未出现念珠菌病病例。

ESO-101 has received Orphan Drug Designation from the U.S. FDA for the treatment of EoE, underscoring its potential as a transformative therapy in this underserved patient population.

ESO-101 已获得美国 FDA 授予的孤儿药资格，用于治疗嗜酸性食管炎 (EoE)，凸显了其在这一服务不足的患者群体中作为变革性疗法的潜力。

For more information, please visit

欲了解更多信息，请访问

www.esocapbiotech.com

www.esocapbiotech.com

and follow EsoCap on

并关注 EsoCap 的

LinkedIn

领英

.

。

Contact

联系人

EsoCap AG

埃索卡普股份公司

Isabelle Racamier, CEO

伊莎贝尔·拉卡米耶，首席执行官

Malzgasse 9

麦尔兹加瑟街9号

4052 Basel, Switzerland

瑞士巴塞尔，邮编4052

This email address is being protected from spambots. You need JavaScript enabled to view it.

该电子邮件地址正受到防垃圾邮件机器人的保护。您需要启用 JavaScript 才能查看它。

1 Lucendo AJ, el al. Clinical trial: Safety and efficacy of a novel oesophageal delivery system for topical corticosteroids versus placebo in the treatment of eosinophilic oesophagitis. Aliment Pharmacol Ther 2025;

1 Lucendo AJ，等。临床试验：新型食管递送系统局部使用皮质类固醇与安慰剂治疗嗜酸性食管炎的安全性和有效性。《胃肠药理学与治疗学》2025；

https://doi.org/10.1111/apt.18443

https://doi.org/10.1111/apt.18443

2 C Rosenbaum et al, 2021.

C·罗森鲍姆等，2021年。

Functionality and Acceptance of the EsoCap System—A Novel Film-Based Drug Delivery Technology: Results of an In Vivo Study.

EsoCap系统——一种新型的基于薄膜的药物递送技术的功能性和接受性：一项活体研究的结果。

Pharmaceutics, 13 (6): 828.

药剂学，13（6）：828。

3 Krause et al., 2020.

3 Krause 等，2020。

The EsoCap-system – An innovative platform to drug targeting in the esophagus. Journal of controlled release

EsoCap系统——一种创新的食管药物靶向平台。《控制释放杂志》

,

，

327:1–7.

327:1–7。

4 Burton et al., 1995.

4 Burton 等，1995。

Intragastric Distribution of Ion-exchange Resins: a Drug Delivery System for the Topical Treatment of the Gastric Mucosa.

胃内离子交换树脂的分布：一种用于胃黏膜局部治疗的药物递送系统。

J. of Pharmacy and Pharmacology, 47: 901-906.

药学与药理学杂志，47卷：901-906页。

Keywords: Clinical Trials, Phase II as Topic; Drug Delivery Systems; Eosinophilic Esophagitis; Deglutition Disorders; Mometasone Furoate; Heartburn; Eosinophils; Deglutition; Eosinophilic enteropathy; Adrenal Cortex Hormones; Vomiting; Anti-Inflammatory Agents; Inflammation; EsoCap; ESO-101; Mucoadhesive film; ACESO trial; Phase II study; Digestive Disease Week; DDW 2025; Clinical trial; Esophageal mucosa; Esophageal inflammation; Endoscopic response; Dysphagia; Esophageal lining; Clinical efficacy; Local immune-mediated disease; Orphan Drug Designation; Basel; Switzerland; University of North Carolina; Prof.

关键词：临床试验，II期主题；药物递送系统；嗜酸性粒细胞性食管炎；吞咽障碍；糠酸莫米松；胃灼热；嗜酸性粒细胞；吞咽；嗜酸性胃肠病；肾上腺皮质激素；呕吐；抗炎药；炎症；EsoCap；ESO-101；粘附膜；ACESO试验；II期研究；消化疾病周；DDW 2025；临床试验；食管黏膜；食管炎症；内镜反应；吞咽困难；食管内壁；临床疗效；局部免疫介导疾病；孤儿药资格；巴塞尔；瑞士；北卡罗来纳大学；教授。

Evan Dellon; Controlled drug release.

埃文·德拉恩；药物控释。

Source: Biotech Newswire

来源：生物技术新闻社