SAN FRANCISCO and BOSTON, July 07, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, today announced positive 16-week data from Part A of the Phase 2 APEX clinical trial of APG777, a potential best-in-class anti-IL-13 antibody, in patients with moderate-to-severe atopic dermatitis (AD)..

旧金山和波士顿，2025年7月7日（环球新闻社）-- Apogee Therapeutics, Inc.（纳斯达克股票代码：APGE）是一家临床阶段的生物技术公司，致力于在最大的炎症和免疫学（I&I）市场中推进优化的、新型生物制品，这些生物制品具有差异化疗效和剂量潜力。该公司今日宣布了其潜在的最佳抗IL-13抗体APG777在治疗中重度特应性皮炎（AD）患者的2期APEX临床试验A部分中取得的积极16周数据。

“With two out of every three patients treated with APG777 achieving EASI-75 response at Week 16 in the Phase 2 APEX Part A trial, APG777 demonstrated the highest EASI-75 response rate both on a topline and placebo-adjusted basis for any biologic in a global study to date, reinforcing its potential best-in-class profile for patients with moderate-to-severe atopic dermatitis,” said Michael Henderson, M.D., Chief Executive Officer of Apogee.

“在二期APEX A部分试验中，每三位接受APG777治疗的患者中有两位在第16周达到了EASI-75反应，APG777在所有全球研究中的生物制剂里展现了最高的EASI-75反应率，无论是从总体数据还是安慰剂调整基础上来看，均巩固了其中重度特应性皮炎患者潜在最佳治疗选择的地位，”Apogee首席执行官迈克尔·亨德森博士表示。

“APG777 has the potential to set a new standard of care by offering improved clinical responses with transformational quarterly or better maintenance dosing — benefitting patients, providers, and payers. Today’s results bring us closer to that vision, and we believe further de-risks APG777’s path to approval.

“APG777 有望通过提供更佳的临床反应和变革性的每季度或更长周期的维持剂量，树立新的治疗标准——造福患者、医疗服务提供者和支付方。今天的结果让我们离这一愿景更近一步，我们相信这将进一步降低 APG777 获批的风险。”

In addition, I am excited for our two upcoming readouts to potentially even further improve on efficacy results — the accelerated APEX Part B testing higher exposures that is now expected to readout mid-2026, and the ongoing APG279 (IL-13 + OX40L) head-to-head trial against DUPIXENT expected to readout in the second half of 2026.”.

此外，我对即将到来的两项数据读出感到兴奋，它们有可能进一步提升疗效结果——预计在2026年年中读出的加速APEX Part B测试更高暴露量的数据，以及预计在2026年下半年读出的正在进行的APG279（IL-13 + OX40L）与DUPIXENT的头对头试验。

“Today’s results from APEX Part A demonstrate strong efficacy results across all key endpoints,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “In addition to these potentially best-in-class results, increased response rates were observed in patients with higher exposures, supporting our exposure-response hypothesis which we continue to further test in APEX Part B.

“今天来自APEX A部分的结果显示在所有关键终点上都取得了显著的疗效，”Apogee首席医疗官Carl Dambkowski博士说道。“除了这些潜在的同类最优结果外，在暴露量较高的患者中观察到更高的应答率，这支持了我们的暴露-应答假设，我们将在APEX B部分继续进一步验证这一假设。”

Combined with a favorable safety profile, these findings reinforce APG777’s potential to deliver meaningful and durable benefit to patients while significantly reducing dosing frequency compared with existing agents. On behalf of the entire Apogee team, I’d like to extend our gratitude to the patients and physicians for their support in the successful execution of this important trial.” .

结合其良好的安全性，这些研究结果进一步证实了APG777在显著减少给药频率的同时，有望为患者带来有意义且持久的益处。我谨代表Apogee全体团队，向参与这项重要试验的患者和医生表示衷心感谢，感谢他们的支持使试验得以成功完成。"

APEX Phase 2 Part A Key 16-Week Results

APEX第二阶段A部分关键16周结果

The Phase 2 APEX clinical trial is a randomized, placebo-controlled study evaluating APG777 in patients with moderate-to-severe AD. Part A of the trial enrolled 123 adult patients who were randomized 2:1 to APG777 versus placebo and received an induction regimen dosing of 720mg at Weeks 0 and 2, followed by 360mg at Weeks 4 and 12.

第二阶段的APEX临床试验是一项随机、安慰剂对照研究，评估APG777在中度至重度AD患者中的效果。试验的A部分招募了123名成年患者，按2:1的比例随机分配至APG777组或安慰剂组，并在第0周和第2周接受720mg的诱导方案剂量，随后在第4周和第12周接受360mg的剂量。

Patients benefiting from treatment continued maintenance dosing, evaluating 3- or 6-month dosing of APG777. The primary endpoint of Part A is mean percentage change in Eczema Area Severity Index (EASI) score from baseline at Week 16. Secondary endpoints include EASI-75, EASI-90, Validated Investigator Global Assessment (IGA) 0/1 and Itch Numeric Rating Scale (NRS) at Week 16..

从治疗中受益的患者继续维持剂量，评估APG777的3个月或6个月剂量。A部分的主要终点是第16周时湿疹面积和严重程度指数（EASI）评分相对于基线的平均百分比变化。次要终点包括第16周的EASI-75、EASI-90、验证的研究者整体评估（IGA）0/1以及瘙痒数字评分量表（NRS）。

Initial 16-week findings from APEX Part A include efficacy results, which compare favorably versus standard of care across endpoints as well as rapid onset of itch relief and lesion reduction, and a favorable safety profile consistent with its class:

APEX Part A的初始16周研究结果包括疗效数据，与标准治疗相比，在各个终点指标上均表现出色，同时具有快速止痒和病灶减少的效果，安全性良好，与其药物类别一致。

The trial met its primary endpoint, with APG777 showing significantly greater least squares mean percent change from baseline at Week 16 with an EASI reduction of 71.0% compared to placebo of 33.8% (p < 0.001).

该试验达到了主要终点，APG777在第16周时相较于基线的最小二乘均值百分比变化显著更大，EASI评分减少71.0%，而安慰剂组为33.8%（p < 0.001）。

Highest absolute and placebo-adjusted EASI-75 of any biologic with 66.9% of participants treated with APG777 achieving EASI-75 compared to 24.6% on placebo (p < 0.001)

任何生物制剂中最高的绝对和安慰剂校正的EASI-75，66.9%的接受APG777治疗的参与者达到EASI-75，而安慰剂组为24.6%（p < 0.001）。

Pre-specified sensitivity analysis showed consistent results in both moderate and severe patients

预先指定的敏感性分析显示，在中度和重度患者中结果一致。

Additionally, an exposure-response relationship was observed, with patients in the two highest quartiles of exposures achieving the highest EASI-75 response at Week 16, 83.3% for quartile three and 89.5% for quartile four

此外，还观察到一种暴露-反应关系，暴露量最高的两个四分位数的患者在第16周达到了最高的EASI-75反应率，第三个四分位数为83.3%，第四个四分位数为89.5%。

APEX Part B is testing a higher dose of APG777, which is projected to achieve average exposures in line with the highest quartile of exposures from Part A

APEX B部分正在测试更高剂量的APG777，预计将达到与A部分最高四分位数相当的平均暴露水平。

Serious treatment-emergent adverse events (TEAEs) were rare for APG777-exposed patients (1.2% vs. 2.4% in placebo)

APG777暴露的患者中，严重的治疗相关不良事件（TEAEs）很少见（1.2% vs. 安慰剂组2.4%）。

Discontinuation rate due to AEs was low for APG777-exposed patients (2.4%)

因不良事件导致的停药率在APG777暴露的患者中较低（2.4%）

The most common TEAEs (occurring in ≥5% of patients in either treatment group) were non-infective conjunctivitis, upper respiratory tract infection, and nasopharyngitis, the latter two numerically lower in APG777 treated patients

最常见的治疗期间出现的不良事件（TEAEs，发生在任一治疗组中≥5%的患者）为非感染性结膜炎、上呼吸道感染和鼻咽炎，其中后两者在APG777治疗的患者中数值较低。

There were 0 injection site reactions in the APG777 group

APG777组未出现注射部位反应。

“The Phase 2 Part A results are exciting, with APG777 demonstrating promising efficacy results from only four injection days over the initial 16-week induction period,” said Emma Guttman-Yassky, M.D., Ph.D., Waldman Professor of Dermatology and Immunology and Health System Chair of the Kimberly and Eric J.

“第二阶段A部分的结果令人兴奋，APG777在最初的16周诱导期内仅通过四次注射就展示了良好的疗效，”皮肤病学和免疫学教授、医学博士Emma Guttman-Yassky以及Kimberly和Eric J.健康系统主席表示。

Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City. “Despite meaningful advances in atopic dermatitis treatment, there remains a significant unmet need to reduce the injection burden for patients while continuing to improve patient outcomes. I look forward to seeing the first half-life extended antibody in AD progress and I am excited about Apogee’s studies that are bringing this therapy closer to patients.”.

纽约市西奈山伊坎医学院沃尔德曼皮肤科系。“尽管在特应性皮炎治疗方面取得了有意义的进展，但仍然存在一个重要的未满足需求，即在继续改善患者疗效的同时减少患者的注射负担。我期待看到首个半衰期延长的抗体在特应性皮炎中的进展，并对Apogee公司让这种疗法更接近患者的研究感到兴奋。”

APEX Part B is a placebo-controlled dose optimization with approximately 280 patients randomized 1:1:1:1 to high, medium, or low dose APG777 versus placebo. Part B continues to enroll participants with readout expected in mid-2026. Data readout from the maintenance phase of APEX Part A, testing 3- and 6-month maintenance dosing, is expected in the first half of 2026..

APEX B部分是一项安慰剂对照的剂量优化研究，约280名患者以1:1:1:1的比例随机分配至高、中、低剂量APG777或安慰剂组。B部分继续招募参与者，预计在2026年年中获得结果。APEX A部分维持阶段的数据读出，测试3个月和6个月的维持剂量，预计在2026年上半年获得。

About Apogee

关于Apogee

Apogee Therapeutics is a clinical-stage biotechnology company advancing optimized, novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of Atopic Dermatitis (AD), asthma, Chronic Obstructive Pulmonary Disease (COPD), Eosinophilic Esophagitis (EoE) and other I&I indications.

Apogee Therapeutics 是一家临床阶段的生物技术公司，致力于推进优化的、新型生物制剂，在最大的炎症和免疫（I&I）市场中具有差异化疗效和剂量潜力，包括用于治疗特应性皮炎（AD）、哮喘、慢性阻塞性肺病（COPD）、嗜酸性粒细胞性食管炎（EoE）以及其他炎症和免疫相关适应症。

Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the Company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets.

Apogee的抗体项目旨在通过针对成熟的机制和结合先进的抗体工程技术来克服现有疗法的局限性，从而优化半衰期及其他特性。公司最先进的项目APG777最初正在开发用于治疗阿尔茨海默病（AD），这是最大且渗透率最低的炎症与免疫市场之一。

With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the Company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care.

凭借其产品组合中的四个已验证靶点，Apogee 旨在通过其新型抗体的单药疗法和联合疗法实现同类最佳的疗效和剂量。基于广泛的管线和深厚的专业知识，公司相信能够为那些目前标准治疗未能满足需求的患者带来价值和显著益处。