National Jewish Health, Inc.

Bringing medical advances from the lab to the clinic. （点击👆，免费获取美国NIH基金资助项目大数据分析） 特应性皮炎（Atopic Dermatitis, AD） 是一种慢性、复发性、炎症性皮肤疾病，常伴有强烈瘙痒、皮肤干燥和屏障功能受损。它通常发生于儿童期，但可持续或首次发病于成人。AD 的发病机制复杂，涉及遗传易感性、免疫系统失衡（尤其是Th2介导的炎症反应）、皮肤微生物群失调以及环境因素等。该病不仅影响皮肤健康，还严重损害患者的睡眠、心理状态和生活质量。 最新研究进展 免疫通路研究与靶向治疗的突破：对Th2相关细胞因子（如IL-4、IL-13、IL-31）的深入研究推动了生物制剂的发展。代表药物**dupilumab（度普利尤单抗）**通过阻断IL-4Rα信号通路显著改善中重度AD症状，成为里程碑式疗法。新一代靶向药物（如IL-13单抗lebrikizumab、IL-31受体拮抗剂nemolizumab）正在临床试验中显示良好疗效。 小分子口服药物的崛起：Janus激酶（JAK）抑制剂（如upadacitinib、abrocitinib、baricitinib）通过调控多条细胞因子通路，快速缓解瘙痒和皮疹，已成为生物制剂之外的重要治疗选择。 皮肤屏障修复与微生物组研究：研究证实皮肤屏障蛋白（如filaggrin）突变及金黄色葡萄球菌（S. aureus）定植与AD严重程度密切相关。针对皮肤菌群重塑和屏障修复的外用新策略（益生菌霜、脂质调节制剂）正逐步进入临床。 系统性管理理念形成：从单纯皮肤病管理转向全身性炎症疾病干预，强调与哮喘、过敏性鼻炎等共病的综合管理。 亟需解决的临床痛点 早期诊断与分层不足：不同人群（儿童、成人、慢性复发型）病理特征差异显著，缺乏精准的分型与预测标志物。 治疗长期依从性差：外用药治疗需长期坚持，患者依从性与安全性监测不足。 难治性与复发性管理挑战：部分患者对生物制剂或JAK抑制剂反应有限，停药后易复发。 安全性与成本问题：长期系统性免疫调节治疗的安全性（尤其是JAK抑制剂的感染与血栓风险）及经济负担亟待优化。 心理与社会影响被低估：AD常伴焦虑、抑郁等心理共病，但心理支持体系尚未完善。 特应性皮炎的治疗正从传统的对症管理转向以免疫通路精准干预为核心的个体化治疗。未来的研究重点应聚焦于早期分型诊断、生物标志物发现、长期疗效与安全性评估，以及皮肤—免疫—微生态互作机制的深入解析，以实现更持久、更安全的疾病控制与生活质量提升。 我们仅对美国国立卫生研究院（NIH）资助的在研特应性皮炎相关项目进行梳理，希望给同仁们的选题思路提供一点启发。 2025年，以 "Atopic Dermatitis"为检索词、在题目中进行检索，美国NIH针对特应性皮炎的在研有30项。 一，谁获得了这些研究？ 1. 在研基金最多的PI： LEUNG, DONALD YM，国家犹太人健康（NATIONAL JEWISH HEALTH） NADEAU, KARI C.，哈佛大学（HARVARD UNIVERSITY） GEHA, RAIF SALIM，波士顿儿童医院（BOSTON CHILDREN'S HOSPITAL ） 2，基金最多的研究机构 NATIONAL JEWISH HEALTH 美国国家犹太健康中心 HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH 哈佛大学公共卫生学院 UNIVERSITY OF CALIFORNIA, SAN FRANCISCO 加利福尼亚大学旧金山分校 BOSTON CHILDREN'S HOSPITAL 波士顿儿童医院 WASHINGTON UNIVERSITY 华盛顿大学（圣路易斯） 二，研究热点 研究领域总览（根据关键词） 研究大的方向也包括儿童特应性皮炎（Pediatric Atopic Dermatitis）、免疫反应（Immune Responses）、金黄色葡萄球菌（S. Aureus）等。 三，借鉴与突破 我们也分享在该领域的几项课题摘要，希望对同仁们有所启发。 A，ATOPIC DERMATITIS RESEARCH NETWORK LEADERSHIP CENTER Atopic dermatitis (AD) is the most common chronic inflammatory skin disease in the general population. AD is associated with defective skin barrier function, microbial dysbiosis, as well as various cutaneous immune abnormalities including type 2 inflammation and decreased cutaneous host defense. These abnormalities translate into multiple phenotypes and endotypes that are not fully defined and therefore, effective targeted therapies, beyond type 2 immune blockade, to reverse these various subsets of AD are lacking. Beyond its effects on cutaneous defense, AD is associated with systemic inflammation and appears to be the first step in the development of other atopic conditions including food allergy and asthma. This grant application is being submitted in response to RFA-AI-19-014, Atopic Dermatitis Research Network-Leadership Center (ADRN-LC). The goal of this proposal is to create an ADRN-LC which will provide the overall scientific strategy and organizational structure to the ADRN and will interact closely with the ADRN Clinical Research Centers (ADRN-CRCs), to support the conduct of multi-site clinical studies and trials that will elucidate mechanisms of skin barrier dysfunction and cutaneous immune responses in atopic dermatitis (AD). The central hypothesis in this application is that different phenotypes and endotypes of AD are associated with distinct defects in their skin barrier, microbiome, and skin immune responses which can be characterized by novel approaches to skin sampling and open up avenues for paradigm shifting therapeutic interventions to benefit patients with severe persistent AD. We will achieve our objectives with the following Aims: · Specific Aim 1: To establish an Administrative and Clinical Research Operations Leadership Center that will be responsible for implementation, coordination, and funding of clinical trials and studies for the ADRN-LC in research areas evaluating mechanism and treatment of AD. · Specific Aim 2: To develop a Network-wide multi-center ADRN clinical trial to evaluate the long- term effects of targeted microbiome transplantation on clinical outcomes in AD as well as epithelial barrier function, microbial dysbiosis, and cutaneous immunity. · Specific Aim 3: To design a Network-wide ADRN one-year observational study to assess the stability of AD phenotypes/endotypes using a Network correlation analysis of transcriptomics (conventional and single cell RNA sequencing), skin tape proteomics, lipidomics, and microbiome over time in subjects with persistent mild vs. persistent severe AD and assessment of therapeutic responses to topical corticosteroids and Dupilumab. · Specific Aim 4: To carry out a Network-wide multi-center ADRN clinical trial to examine the effects of targeted IL-1 blockade on the clinical outcome, skin microbiome, epithelial skin barrier, and cutaneous immune response in AD patients who have an inadequate response to IL-4/IL-13 blockade using Dupilumab therapy. Accomplishment of these Specific Aims will contribute to novel and important advances in our understanding of mechanisms of host skin defense and paradigm-shifting treatments of AD. The establishment of this ADRN-LC will also provide budgetary and scientific resources for the Systems Biology of Early Atopy Birth Cohort study that is under development by the Consortium for Food Allergy Research (CoFAR). B, SEAL (Stopping Atopic dermatitis and ALlergy) Study: Prevent allergy by enhancing the skin barrier SEAL (Stopping Eczema and ALlergy) Study Food allergy (FA) is an epidemic among children in the U.S., U.K., and other countries. There is increasing evidence that epicutaneous allergen sensitization through a dysfunctional skin barrier results in allergic responses whereas early consumption of food allergens induces oral tolerance, as described by the dual allergen exposure hypothesis. In the Learning Early About Peanut LEAP and Enquiring About Tolerance (EAT) studies, dry skin and the severity and the duration of eczema or atopic dermatitis (AD) in the 1st year of life were predictors of peanut allergy (PA) and sensitization. In the SEAL study, we aim to intervene very early in a high-risk infant group, as soon they have the earliest onset of dry skin or eczema in the 1st 10 weeks of life, but before they have developed allergies. By reducing the duration and severity of eczema and preventing eczema exacerbations, we aim to prevent epicutaneous allergen sensitization and significantly reduce the incidence of FA. Our primary objective is to test if the combination of trilipid skin emollient use early in life with proactive topical steroids decreases the prevalence of FA compared to controls. We propose a randomized (1:1), controlled trial design for infants with dry skin or eczema (n=750 total) to compare the effect of proactive treatment against a reactive treatment group for the prevention of FA, by reducing dry skin, and the severity and duration of eczema in early infancy. We will test our hypothesis with the following specific aims using world-class clinical research units known for excellent recruitment and retention of patient cohorts, mechanistic testing, and state of the art research. Specific Aim 1: To determine if proactive versus reactive treatment will reduce the occurrence of FA in a prospective, randomized, and controlled intervention trial of infants with eczema. Specific Aim 2: To test whether the skin of children in the proactive treatment will show improved epithelial barrier markers with increased commensal bacteria colonization. Specific Aim 3: To determine whether proactive treatment will be associated with protective immune responses. If the aims are achieved, our proposal will make a clinical impact by providing a new, clinical strategy to prevent the occurrence of FA in young infants that present with the earliest signs of dry skin or eczema. 天下科研，唯快不破。 看了上述检索结果，对您有什么启发？赶快行动吧。 如果您需要HS提供类似的选题大数据分析，可阅读下面的推文： 应用这个“外挂”，张医生的选题思路源源不断、文章不断发表！ 关键词： #美国基金解析；#Hanson临床科研；#Healsan医路成长 作者：Amber Wang，助理：ChatGPT 美国Healsan(恒祥医学)，专长于Healsan™医学大数据分析、基于大数据的HansonCR™临床科研支持，以及MedEditing™的医学编辑服务。主要为医院科研处、生物制药公司和医生科学家提供数据分析和SCI报告，成为诸多机构的“临床科研外挂”。 网址：https://healsan.com/ 点击👆；From Bench to Bedside, Healsan Paves the Path. ▼ 支持基金申请和SCI论文发表，推动临床科研的创新与发展。 基于Healsan™文献计量大数据的系列推文，全年安排如下；目前是研究热门靶点系列。 ▲ 每年1-2月 ▲ 每年3-4月 ▲ 每年5-6月 ▲ 每年7-8月 ▲ 每年9-10月 ▲ 每年11-12月 （点击👆图片，进入自己感兴趣的专辑） ▼ 临床科研技巧及文献更新 （点击👆图片，进入自己感兴趣的专辑。或点击“资源”，浏览本公众号所有资源） 更多高质量的医学生物科研、职业发展、及赴美访学留学推文，点击左下角“阅读原文”可见；电子邮箱注册后，可以每天免费收到高质量科研推送。

Independent Data Monitoring Committee (DMC) has approved continuation of trial as planned with no modifications Full study enrollment expected by end of 2025 COLUMBUS, OH, USA I June 16, 2025 I Clarametyx Biosciences, Inc . (“Clarametyx”), a clinical-stage biotechnology company developing immune-enabling therapies and vaccines to address biofilm-driven chronic respiratory diseases, announced today that it is advancing a Phase 1b/2a clinical trial evaluating its novel immune-enabling antibody therapy CMTX-101 to treat cystic fibrosis (CF)-associated pulmonary infections, based on the DMC’s approval to proceed following results of a pre-specified interim analysis. “Interim findings from this study have identified encouraging trends that support the potential benefit of CMTX-101, with no safety issues,” said Jerry Nick, MD, Professor in the Division of Pulmonary, Critical Care and Sleep Medicine at National Jewish Health, and primary investigator of the study. “The next portion of the trial will provide important insights on the potential therapeutic impact of CMTX-101 for the CF population as a novel solution to reduce the burden of chronic infections.” The ongoing randomized, double-blind, placebo-controlled clinical trial is assessing CMTX-101 as an adjunctive therapy to standard of care antibiotics in people with CF, evaluating safety and tolerability, pharmacokinetics, immunogenicity, reduction of pulmonary Pseudomonas aeruginosa burden, and additional exploratory endpoints. An interim analysis of data from the first 21 participants enrolled met the pre-specified criteria to continue the trial at both 5 and 30 mg/kg dose levels. Participants treated with CMTX-101 demonstrated a reduction in P. aeruginosa burden based on prespecified statistical criteria and CMTX-101 was shown to be present in the sputum of all treated participants. Importantly, CMTX-101 was generally well tolerated, consistent with the findings reported in a prior clinical study, and no antidrug antibodies were detected. The upcoming portion of the study will continue evaluating both doses of CMTX-101 versus placebo among approximately 20 additional participants from 23 study sites, including significant support from the Cystic Fibrosis Therapeutics Development Network. Study enrollment is expected to be complete by the end of 2025. More information on the study and participating sites is available at ClinicalTrials.gov ( http://www.clinicaltrials.gov/ ) using the identifier NCT06159725 . “We are pleased that the findings from the first 21 participants enrolled support progressing the study without modification. The full dataset, which will include exploratory endpoints such as respiratory function, inflammatory biomarkers and quality of life assessments, will help us further understand the full potential of CMTX-101 as a novel therapeutic solution to a variety of chronic respiratory conditions,” said David V. Richards, Chief Executive Officer, Clarametyx. “We extend our gratitude to the Cystic Fibrosis Therapeutics Development Network, clinical investigators, and the participants and families for their continued participation in this important research.” About CMTX-101 CMTX-101 is an investigational immune-enabling antibody therapy in development to treat chronic and recalcitrant respiratory infections. The therapy is designed to precisely and rapidly destroy the universal underlying structure of bacterial biofilms to undermine extracellular bacterial defenses and enable more effective antibiotic and immune intervention. Because the target is universally present across bacteria, the approach can be employed to treat a range of bacterial infections and pathogen types. The goal of treatment is to dramatically improve the effectiveness of antibiotic therapies and innate immune system effectors, improving the time to resolution of the infection and reducing the need for repeated courses of antibiotics. It is currently in development to treat cystic fibrosis-associated infections, with opportunities to expand to other chronic respiratory infections including nontuberculous mycobacterial (NTM) lung disease, non-CF bronchiectasis (NCFB), and chronic obstructive pulmonary disease (COPD). About Clarametyx Biosciences Clarametyx Biosciences is combating the formidable challenge of chronic, recalcitrant respiratory infections through an innovative technology platform targeting the biofilm—a protective layer around bacteria—to enable a more effective immune response and antibiotic intervention. The Columbus, Ohio-based company is building a pipeline of immune-enabling therapies and vaccines, including CMTX-101, which is in a Phase 2 study for infections associated with cystic fibrosis, and CMTX-301, which is in early development. For more information, visit us on the web or on LinkedIn . SOURCE: Clarametyx Biosciences

CHICAGO, June 05, 2025 (GLOBE NEWSWIRE) -- The Foundation for Sarcoidosis Research (FSR) and the American Thoracic Society (ATS) are pleased to announce that Mark Mallozzi, MD, MPH has been selected to receive the 2025 ATS/FSR Partner Grant, awarded to support innovative research in sarcoidosis and advance patient care. The FSR/ATS Partner Grant, a cornerstone of both organizations’ commitment to fostering early-career investigators, provides $100,000 in funding—$50,000 per year over two years—to support groundbreaking research projects that have the potential to significantly impact the understanding and treatment of sarcoidosis. Since 2005, this partnership has funded over $1 million in sarcoidosis research, catalyzing further advancements in the field. “Dr. Mallozzi’s grant will provide the scientific community with valuable insight into the environmental causes of sarcoidosis,” said Mary McGowan, President and CEO of FSR. “We are pleased to partner with the American Thoracic Society to support dedicated investigators like Dr. Mallozzi who are committed to increasing the understanding of this complex disease.” This year’s awardee, Mark Mallozzi, MD, MPH from National Jewish Health was selected for his project titled “Association of PM2.5 exposure with sarcoidosis outcomes at baseline and longitudinal follow-up”. This study will look at a possible link between air pollution and sarcoidosis. “This grant will be essential in advancing my career as a physician-scientist focusing on sarcoidosis and environmental exposures,” said Mark Mallozzi MD. “Through this project, I will advance my research skills and scientific writing and presenting, build a network of collaborators, and produce foundational data for future projects. This project is a meaningful step in my goal of securing a National Institutes of Health Research Career Development Award (K).” “We are immensely grateful to our non-profit partners for their continued collaboration and for their support of the young researchers who are contributing to greatly-improved outcomes for patients across the spectrum of respiratory health,” said Kamran Atabai, MD, chair of the ATS Scientific Grant Review Committee. For more information about the FSR research funding programs, visit https://www.stopsarcoidosis.org/fsr-grants . About Sarcoidosis Sarcoidosis is a rare inflammatory disease characterized by granulomas—tiny clumps of inflammatory cells—that can form in one or more organs. 90% of patients living with sarcoidosis have lung involvement. Despite advances in research, sarcoidosis remains challenging to diagnose, with limited treatment options and no known cure. Approximately 175,000 people live with sarcoidosis in the United States. About the Foundation for Sarcoidosis Research The Foundation for Sarcoidosis Research (FSR) is the leading international organization dedicated to finding a cure for sarcoidosis and improving care for those living with the disease through research, education, and support. For more information about FSR and its community programs, visit: www.stopsarcoidosis.org . About the ATS Foundation Since its inception, the ATS Foundation Research Program has awarded more than $24 million in early career researchers has leveraged well over $880 million in NIH funding and breakthroughs in respiratory medicine. You can learn more about our most recent awardees here . Media Contact: Cathi Davis, Director of Communications and Marketing Foundation for Sarcoidosis Research 312-341-0500 cathi@stopsarcoidosis.org A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/46aa564f-1606-4532-bb78-57eb14158704 Mark Mallozzi, MD, MPH FSR/ATS Partner Grant Awardee Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.