CAMBRIDGE, Mass. & SEOUL, South Korea--(BUSINESS WIRE)--Shaperon, Inc. (Kosdaq: 378800), a biotechnology company developing innovative immune drugs, announced the enrollment of the first patient in the Phase 2 clinical trial for Nugel, its therapy for Atopic Dermatitis. This milestone marks the start of a crucial phase in Shaperon’s effort to advance treatment for patients globally..

麻省剑桥和韩国首尔——（商业新闻短讯）——开发创新免疫药物的生物技术公司Shaperon，Inc.（Kosdaq:378800）宣布招募第一名患者参加Nugel的2期临床试验，Nugel治疗特应性皮炎。这一里程碑标志着Shaperon努力推进全球患者治疗的关键阶段的开始。。

With FDA approval secured for the Global Phase 2 Clinical Trials (IND) of Nugel in September 2023, Shaperon is dedicated to evaluating its efficacy in improving the Eczema Area Severity Index (EASI) across a diverse cohort of 210 patients with mild to moderate atopic dermatitis. Employing a rigorous double-blind, placebo-controlled methodology, the trial is anticipated to conclude by the first half of 2026..

2023年9月，随着FDA批准Nugel的全球2期临床试验（IND），Shaperon致力于评估其在210名轻度至中度特应性皮炎患者中改善湿疹面积严重程度指数（EASI）的疗效。该试验采用严格的双盲安慰剂对照方法，预计将于2026年上半年结束。。

Market research forecasts indicate a robust growth of over 8.7%, projecting the global atopic dermatitis market to reach $19.1 billion by 2030. Presently, patients rely on steroids and FDA-approved medications, yet there remains a pressing need for novel drugs due to their adverse effects and limited efficacy..

市场研究预测显示，增长强劲，超过8.7%，预计到2030年，全球特应性皮炎市场将达到191亿美元。目前，患者依赖类固醇和FDA批准的药物，但由于其不良反应和疗效有限，仍然迫切需要新药。。

Of particular note, more than 70% of patients exhibit positive responses to the biomarker discovered during Shaperon's phase 2 clinical trials in Korea, categorized as 'A type A atopic patients.' This treatment, distinguished by its superior safety and efficacy compared to existing JAK inhibitors or PDE4 inhibitors in the market, has garnered attention at U.S.

特别值得注意的是，超过70%的患者对Shaperon在韩国进行的2期临床试验中发现的生物标志物表现出阳性反应，被归类为“A型特应性患者”与市场上现有的JAK抑制剂或PDE4抑制剂相比，这种治疗以其优越的安全性和有效性而著称，已引起美国的关注。

and European forums. Shaperon has already initiated patent applications for this biomarker, enabling tailored treatments for patients showing exceptional responses to Nugel..

和欧洲论坛。Shaperon已经启动了这种生物标志物的专利申请，为对Nugel表现出异常反应的患者提供了量身定制的治疗。。

Nugel represents a paradigm shift in atopic dermatitis therapy as the world's first inflammation control drug targeting 'GPCR19' action. Its unique mechanism of action, exclusive to immune-related cells, offers minimal side effects while effectively addressing inflammatory pathways. Beyond atopic dermatitis, Nugel holds promise for treating a spectrum of skin conditions, further underscoring its potential impact on global healthcare..

Nugel作为世界上第一种针对“GPCR19”作用的炎症控制药物，代表了特应性皮炎治疗的范式转变。其独特的作用机制，免疫相关细胞独有，提供最小的副作用，同时有效解决炎症途径。除特应性皮炎外，Nugel有望治疗一系列皮肤病，进一步突显其对全球医疗保健的潜在影响。。

Dr. Seung-Yong Seong, CEO of Shaperon, reaffirms Shaperon's commitment to advancing Nugel's global presence and facilitating technology transfer through the Phase 2 clinical trials. Leveraging innovative approaches such as a smartwatch-based AI medication management system demonstrates Shaperon's dedication to optimizing patient outcomes and data reliability.

Shaperon首席执行官Seung Yong Seong博士重申，Shaperon致力于推进Nugel的全球影响力，并通过第二阶段临床试验促进技术转让。利用基于智能手表的人工智能药物管理系统等创新方法，证明了Shaperon致力于优化患者结果和数据可靠性。

The establishment of Hudson Therapeutics, Shaperon's U.S.-based subsidiary, reinforces its strategic vision for global expansion and technology exports..

哈德逊治疗公司（Hudson Therapeutics）是Shaperon在美国的子公司，该公司的成立强化了其全球扩张和技术出口的战略愿景。。

ABOUT SHAPERON

关于SHAPERON

Shaperon is a clinical stage biotech company developing novel inflammasome inhibitors. Its unique mechanism of action of GPCR19-P2X7 modulation suppresses a broad spectrum of inflammatory cytokines including IL-1β, IL-18, IL-6, and TNF-α by controlling both priming and activation phase of inflammasome, whereas conventional approaches are designed to suppress only the activation phase.

Shaperon是一家开发新型炎性体抑制剂的临床阶段生物技术公司。它独特的GPCR19-P2X7调节作用机制通过控制炎性体的启动和激活阶段来抑制包括IL-1β，IL-18，IL-6和TNF-α在内的广谱炎性细胞因子，而常规方法旨在仅抑制激活阶段。

With this unique and novel modality which is best suited to address complex immune-mediated inflammatory disorders, Shaperon is currently developing multiple clinical programs in atopic dermatitis, cytokine release syndrome, Alzheimer’s disease, Obesity and MASH..

Shaperon目前正在开发特应性皮炎，细胞因子释放综合征，阿尔茨海默病，肥胖症和MASH的多种临床项目，这种独特而新颖的方式最适合解决复杂的免疫介导的炎症性疾病。。

ABOUT Hudson Therapeutics

关于Hudson Therapeutics

Hudson Therapeutics, a US subsidiary of Shaperon, was founded in 2023 to lead global clinical trials and business development of assets from Shaperon. Hudson’s pipeline includes immunology clinical assets in Atopic Dermatitis, Covid-19, Alzheimer’s Disease and preclinical programs focused in Obesity and other indications, combined with their nanobody platform..

Hudson Therapeutics是Shaperon的美国子公司，成立于2023年，负责领导Shaperon资产的全球临床试验和业务开发。哈德逊的管道包括特应性皮炎，新型冠状病毒肺炎，阿尔茨海默病的免疫学临床资产，以及专注于肥胖和其他适应症的临床前计划，并结合其纳米体平台。。