A Phase III Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5%, Applied Once Daily for 12 Weeks in Patients With Acne Vulgaris (GEDACNE-2)

The clinical trial aims to test a new drug for acne vulgaris. The trial is performed to answer this question "Is it possible to reduce the number of skin lesions on your face/trunk, after daily applications for 12 consecutive weeks of a new drug?". The trial aims to accurately measure the effects of the new treatment (N-Acetyl-GED-0507-34-LEVO gel 5%) and to achieve this, patients will be randomly assigned to one of the following treatments:
* Study drug 1: test item, containing active ingredient
* Study drug 2: a preparation not containing any active ingredient (vehicle) Researchers will compare active to vehicle to see if there are differences in the efficacy.
Participants will:
* Take drug or a placebo every day for 12 weeks
* Visit the site once every 4 weeks for checkups and tests (where applicable)
* Record on a diary the daily applications of the study drug at home, and record any adverse events

开始日期2024-11-19

申办/合作机构

SM2 Software & Services Management SA

NCT07384195

/ Recruiting临床3期

A Phase III Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5%, Applied Once Daily for 12 Weeks in Patients With Acne Vulgaris (GEDACNE-1)

开始日期2024-11-19

申办/合作机构

PPM Insurance Services, Inc.

EUCTR2018-003307-19-DE

/ Completed临床2期

A double-blind, randomized, vehicle-controlled clinical multi-center study to evaluate the efficacy and safety of N-Acetyl-GED-0507-34-LEVO gel, 2 and 5%, applied once daily for 12 weeks in patients with facial acne vulgaris

开始日期2019-06-27

申办/合作机构

SM2 Software & Services Management SA

100 项与 GED-0507-34 相关的临床结果

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100 项与 GED-0507-34 相关的转化医学

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100 项与 GED-0507-34 相关的专利（医药）

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项与 GED-0507-34 相关的文献（医药）

2020-12-01·Cellular & molecular immunology1区 · 医学

GED-0507 is a novel potential antifibrotic treatment option for pulmonary fibrosis

1区 · 医学

Letter

作者: Dubuquoy, Caroline ; Speca, Silvia ; Chavatte, Philippe ; Spagnolo, Paolo ; Desreumaux, Pierre ; Rousseaux, Christel

In this study, we proposed a novel therapeutic approach to lung fibrosis based on the selective PPARγ modulator (SPPARM) GED-0507 to circumvent the potential adverse effects, which are often related to the chem. structure of PPARγ agonists.GED-0507 was administered as preventive and curative treatments in a mouse model of bleomycin (BLM)-induced pulmonary fibrosis.Preventive administration of GED-0507 abolished weight loss, and the 60 mortality observed 3 wk after BLM administration, whereas Pirf did not improve the survival rate or weight loss.Consistent with the body weight loss and high mortality.BLM-treated mice showed an increased area of macroscopic pulmonary lesions.When given as a preventive treatment, GED-0507 decreased the Ashcroft score and lung hydroxyproline content by 47% and 57%, resp., in mice with BLM-induced lung fibrosis.In this context, curative administration of Pirf induced 30% body weight loss at day 21 and 100% mortality at day 24.In conclusion, in vivo studies in BLM-induced pulmonary fibrosis in mice demonstrated that GED-0507 displays beneficial effects on lung fibrosis and may represent a promising therapeutic option for pulmonary fibrosis in humans.

2016-02-01·Inflammatory bowel diseases2区 · 医学

Novel PPARγ Modulator GED-0507-34 Levo Ameliorates Inflammation-driven Intestinal Fibrosis

2区 · 医学

Article

作者: Giovanni Latella ; Ilaria Giusti ; Laurent Dubuquoy ; Christel Rousseaux ; Silvia Speca ; Antonella Vetuschi ; Benjamin Bertin ; Florian Rieder ; Roberta Sferra ; Pierre Desreumaux ; Eugenio Gaudio ; Caroline Dubuquoy

BACKGROUND:

Intestinal fibrosis is mainly associated with Crohn's disease and is defined as a progressive and excessive deposition of extracellular matrix components. No specific antifibrotic therapies are available. In this study, we evaluate the antifibrotic effect of a novel 5-ASA analog able to activate the peroxisome proliferator-activated receptor γ, named GED-0507-34 Levo.

METHODS:

Colonic fibrosis was induced in 110 C57BL/6 mice by 3 cycles of 2.5% (wt/vol) dextran sulfate sodium administration for 6 weeks. The preventive effects of oral daily GED (30 mg · kg(-1) · d(-1)) administration were evaluated using a macroscopic and histological score and also through biological endpoints. Expression of main markers of myofibroblasts activation was determined in transforming growth factor (TGF-β)-stimulated intestinal fibroblasts and epithelial cells.

RESULTS:

GED improved macroscopic and microscopic intestinal lesions in dextran sulfate sodium-treated animals and reduced the profibrotic gene expression of Acta2, COL1a1, and Fn1 by 1.48-folds (P < 0.05), 1.93-folds (P < 0.005), and 1.03-fold (P < 0.05), respectively. It reduced protein levels of main markers of fibrosis (α-SMA and Collagen I-II) and the main TGF-β/Smad pathway components. GED also decreased the interleukin-13 and connective tissue growth factor expression by 1.89-folds (P < 0.05) and 2.2-folds (P < 0.005), respectively. GED inhibited TGF-β-induced activation of both fibroblast and intestinal epithelial cell lines, by regulating mRNA expression of α-SMA and fibronectin, and restoring the TGF-β-induced loss of intestinal epithelial cell markers. GED treatment also reduced the TGF-β and ACTA1 expression in primary human intestinal fibroblasts from ulcerative colitis patients.

CONCLUSIONS:

GED ameliorates intestinal fibrosis in dextran sulfate sodium-induced chronic colitis in mice and regulates major profibrotic cellular and molecular mechanisms.

2014-04-01·The Journal of investigative dermatology1区 · 医学

Preclinical Studies of a Specific PPARγ Modulator in the Control of Skin Inflammation

1区 · 医学

Article

作者: Chavatte, Philippe ; Monteleone, Giovanni ; Bastonini, Emanuela ; Sarra, Massimiliano ; Aspite, Nicaela ; Camera, Emanuela ; Cardinali, Giorgia ; Kovacs, Daniela ; Picardo, Mauro ; Mastrofrancesco, Arianna ; Desreumaux, Pierre

Peroxisome proliferator-activated receptor γ (PPARγ) antagonizes inflammatory signals by interfering with NF-κB nuclear translocation. Consistently, PPARγ agonists have been proposed in various inflammatory skin disorders, but their wide use has been limited by severe side effects. Classes of compounds with specific PPARγ agonism have been designed to selectively target inflammatory pathways. Among these compounds, GED-0507-34L has been developed and recently used in phase II clinical trials for inflammatory bowel diseases. This study was aimed at assessing the role of GED-0507-34L in preclinical models of inflammatory skin diseases. The compound modulated PPARγ function and suppressed the inflammatory process inhibiting NF-κB nuclear translocation with the consequent reduction of inflammatory cytokines expression, such as IL-6, IL-8, IL-12, IL-21, IL-23, tumor necrosis factor-α (TNF-α), and cyclooxygenase-2 (COX-2) in normal human keratinocytes and lymphocytes treated with lipopolysaccharide (LPS) or TNF-α. Moreover, an altered proliferation and expression of differentiation markers induced by TNF-α were also counteracted. In psoriasis-like skin lesions elicited in mice by IL-21, topical application of GED-0507-34L reduced cellular infiltrate and epidermal hyperplasia, normalizing the differentiation process. The results indicate that GED-0507-34L possesses anti-inflammatory properties useful for the management of patients with inflammatory skin diseases including psoriasis. Phase I trial on patients is ongoing.

项与 GED-0507-34 相关的新闻（医药）

2026-01-09

·优麦医生服务号

痤疮诊疗十年：临床医生需要关注的要点

前言寻常痤疮（acne vulgaris）是一种累及毛囊皮脂腺单位的慢性炎症性皮肤病，是全球最常见的皮肤疾病之一。全球总体患病率约为9.4% 1，在青少年群体中高达80%–90%2。虽然痤疮常见于青春期，但并非青少年专属，近年来成人痤疮的发病率逐渐增加，尤其女性患者受到激素水平波动、妊娠和多囊卵巢综合征等因素影响，25岁以上女性的发病率可达12%–22%，而男性约为3%–5%3,4 。在中国，流行病学调查显示总体患病率约为8.1%5，基于多中心社区研究，青少年高峰年龄段的患病率接近一半6。全球疾病负担研究（GBD 2021）提示，1990年至2021年间，青少年痤疮新发病例数由每 10 万人口 8563.4 例上升至每 10 万人口 9790.5 例，痤疮的公共健康负担不断加重 7。痤疮虽然不危及生命，却因面部累及及慢性病程带来显著心理、社会和经济影响。患者常伴随焦虑、自卑和抑郁，严重影响生活质量8 。在经济层面，美国每年痤疮治疗相关支出超过12亿美元 9，在欧洲和中国，患者的就诊和药物花费也逐年增加。由此可见，痤疮不仅是临床最常见的皮肤病之一，更是亟待关注的重要公共卫生问题。背景概述在过去十年中，痤疮的诊断、分型及治疗理念经历了显著的演变。诊断方面，痤疮的典型皮损特征已得到广泛认可，但严重程度分级方法始终未能统一。目前常用的分级工具包括全球痤疮分级系统（GAGS）、研究者总体评估（IGA）以及法国的GEA系统等10 。这些工具在临床和研究中均有应用，但缺乏统一的“金标准”，限制了跨研究的数据比较和循证证据的累积。近年来，随着人工智能技术的引入，影像学辅助诊断逐渐应用于痤疮分级与疗效监测，可通过自动识别病灶实现更客观的评估11。指南的不断更新反映了治疗理念的演变与趋同。美国皮肤科学会（AAD）在2016年发布了循证指南，并于2024年进行了修订12,13；欧洲S3循证指南在2016年完成更新 14；中国也在2019年发布了新版指南5。总体而言，各国指南在分型分级治疗的核心原则上已形成共识：轻中度患者以外用药物为主，首选维甲酸类、过氧化苯甲酰及必要时联合抗生素；重度患者则推荐系统治疗，其中口服异维A酸依然是公认的“金标准”，但使用剂量、疗程等和以往有所不同，逐渐淡化了累积剂量，更加强调低剂量长疗程治疗，最大程度减少不良反应发生。尽管如此，不同地区在细节上仍存在差异。中国指南在强调药物治疗的同时，更突出生活方式和皮肤护理干预，包括饮食、作息和护肤教育，而欧美指南对此的着墨相对较少。近十年来，痤疮研究逐渐从传统的病因学探讨转向多组学整合与新型干预探索。遗传学和多族裔 GWAS 鉴定出新的易感位点，提示皮肤屏障与免疫调控在痤疮中的核心作用 15。微生物组研究揭示痤疮丙酸杆菌亚株在致病性上的差异，强化了“功能失衡而非数量增加”的观点，并推动了噬菌体与微生物移植等创新策略的探索16。单细胞和空间组学进一步证实 NLRP3–IL-1β–Th17 轴在早期病灶中的激活17。与此同时，人工智能在病灶识别与疗效评估中展现出临床价值18，新型递药方式（纳米载体、可溶性微针）及免疫调节剂也不断涌现，为精准与个体化治疗奠定了基础。在治疗手段方面，传统的维甲酸类、过氧化苯甲酰和抗生素仍然是基础，但新型药物不断出现。Trifarotene 作为首个选择性 RAR-γ 激动剂在疗效和耐受性方面表现出优势19；Clascoterone 作为外用雄激素受体拮抗剂，尽管疗效上仍未达到理想目标，但为油脂驱动型痤疮提供了新的治疗机制和思路20；4%米诺环素泡沫剂（FMX101）是一种新型外用抗生素制剂，已在美国和中国获批上市，Ⅲ期随机对照试验证实其在中重度痤疮患者中具有良好的疗效与耐受性，可显著减少炎性及非炎性皮损21。与此同时，光动力疗法、能量设备以及新型经皮递药技术正在被探索用于难治性或伴瘢痕的痤疮患者。尽管取得了进展，痤疮的诊治仍面临诸多挑战。严重程度分级和疗效评价体系尚未统一，影响了多中心研究结果的整合与推广。抗生素耐药问题日益严峻，部分地区痤疮丙酸杆菌对红霉素和克林霉素的耐药率已超过 80%22 。个体化治疗依然不足，缺乏能够预测疗效和复发风险的生物标志物。此外，痤疮后瘢痕与炎症后色素沉着依然是长期困扰患者的重要结局。总体来看，国际研究重点正在从传统的经验管理逐步过渡到精准医学。未来，建立统一的分级体系、加强耐药性管理、推动新药研发并注重长期结局改善，将是痤疮研究和管理的重要方向。热点聚焦过去十年，随着分子生物学、微生物组学、免疫学和药物递送技术的发展，痤疮的发病机制研究及治疗策略取得了重要突破。这些进展推动痤疮治疗进入精准化时代，为难治性患者提供更多选择。 1.痤疮发病机制的新认识 ① 全基因组关联分析（GWAS）在过去十年中极大推进了我们对痤疮遗传基础的理解。2014年，何黎教授团队通过对数千例重度痤疮患者进行GWAS研究，首次鉴定了SELL（选择素L）和DDB2（DNA损伤结合蛋白2）等重型痤疮易感基因位点(23)。这些基因分别参与雄激素代谢、炎症反应及疤痕形成等病理过程。其中，SELL基因编码的L-选择素作为中性粒细胞黏附迁移的关键调控因子，其功能变异可能导致炎症细胞在毛囊皮脂腺单元的异常聚集23。CRELD2、TIMP4和SEMA4B被确认为风险基因，而SLC22A5、SLC22A4、PDGFB、DEXI 和 PDLIM4则表现出显著的保护效应24。基于这些发现，研究者提出SLC22A5激动剂和CRELD2抑制剂可能成为新型靶向治疗策略，为精准医疗提供了理论依据24。 ② 微生物组学研究领域也取得突破性进展。通过全基因组测序和系统发育分析，痤疮丙酸杆菌被重新划分为Ⅰ型（含A1、A2、B、C亚型）、Ⅱ型和Ⅲ型。值得注意的是，Ⅰ型菌株与痤疮病变显著相关，而Ⅱ型则主要定植于健康皮肤25。最新研究揭示，皮肤疾病（特应性皮炎和痤疮）和身体部位决定了痤疮丙酸杆菌基因组的差异，这种致病性差异源于水平基因转移和适应性进化：与金黄色葡萄球菌相比，痤疮丙酸杆菌虽具有相对稳定的基因组和较少的毒力因子，但其在皮脂富集环境中可激活角质形成细胞的炎症通路26。痤疮丙酸杆菌存在显著的体部位定植特异性，这种生态位适应可能为开发部位特异性微生态制剂指明方向。此外，作为皮肤正常菌群，微生物不再简单的认为是痤疮发生的致病因素，可能在调节皮肤尤其是毛囊稳态中发挥重要作用，甚至可能参与调节了毛囊皮脂腺的稳态27,28。近年研究显示口服益生菌有助于痤疮治疗，痤疮患者使用健康型痤疮丙酸杆菌活菌作为外用益生菌治疗后皮肤中c痤疮丙酸杆菌分型多样性增加，非炎症性粉刺数量减少29,30。 ③ 在炎症机制研究方面，2024年免疫学期刊发表的成果证实，NLRP3炎症小体与NETosis（中性粒细胞胞外诱捕网介导的细胞死亡）形成正反馈循环，共同加剧痤疮炎症级联反应31。通过靶向抑制NETosis可显著减轻痤疮丙酸杆菌诱导的皮肤炎症，这为临床治疗提供了新思路。此外，皮脂腺细胞的多重功能被重新定义：除传统认知的皮脂分泌外，它们还能通过分泌趋化因子招募中性粒细胞、单核细胞等免疫细胞，并促进Th17细胞分化32。最新动物实验还发现，痤疮丙酸杆菌可诱导真皮成纤维细胞启动脂肪生成程序，分化为具有抗菌功能的前脂肪细胞，这一发现为理解皮肤免疫-代谢交互作用开辟了新视角33。 ④ 毛囊皮脂腺导管的角化方面，突破了传统的脂质和炎症因子的诱导角化的观点，越来越多的研究显示毛囊皮脂腺干细胞分化在调节毛囊角化和皮脂腺分化上存在平衡，相关因素引起平衡的破坏与毛囊角化和脂质分泌密切相关，未来调节毛囊皮脂腺干细胞分化的方向是治疗痤疮尤其是轻中度痤疮前景方向34,35。展望未来，痤疮研究将向多维度纵深发展：在遗传层面，单细胞测序技术有望解析易感基因的细胞特异性表达模式；微生物组研究需建立菌株-宿主互作的全景图谱，推动噬菌体疗法的临床转化；炎症机制方面，针对NETosis-NLRP3轴的双靶点抑制剂开发或将成为治疗突破点。随着类器官和器官芯片等技术的应用，下一代研究或将揭示痤疮发病的时空动态规律，最终实现从基础研究到个性化治疗的跨越。 2.治疗领域的重大进展 2019年，Trifarotene（Aklief）作为首个选择性靶向γ型维A酸受体（RAR-γ）的外用药问世，在维持抗炎效果的同时显著降低皮肤刺激发生率。同年，FDA批准4%米诺环素泡沫剂用于治疗9岁以上非结节性中重度痤疮患者的炎症性病变，我国III期临床试验进一步证实其可显著减少炎性和非炎性皮损21。此外，NAC-GED（选择性PPARγ调节剂）的Ⅱ期试验显示，5% NAC-GED凝胶可改善研究者整体评分（IGA）并减少总皮损数，疗效优于对照组36。在传统药物优化方面，2021年获批的Twyneo乳膏通过创新的微囊化缓释技术，成功解决了维A酸和过氧化苯甲酰（BPO）的配伍难题。临床研究显示，这种复方制剂可显著减少炎性皮损并减少不良反应。微胶囊化技术不仅提高了药物稳定性，还实现了活性成分的梯度释放。此外，微胶囊化过氧化苯甲酰及克林霉素+维A酸复方制剂可提高疗效并减少耐药性。 Clascoterone（Winlevi）的获批开创了局部抗雄激素治疗的新纪元。其独特的作用机制直接靶向皮脂腺雄激素受体，临床数据显示其可减少炎性喝非炎性皮损数量，且无系统性激素影响20。新型递药系统（如纳米颗粒、外泌体载体、微针等）的发展提高了药物靶向性，减少全身副作用37,38。光动力疗法（PDT）在难治性痤疮中展现出潜力39,40，而激素皮损内注射可作为辅助治疗。对于痤疮瘢痕和炎症后红斑，激光（Nd:YAG）也可起到良好改善效果41。系统治疗方面，异维A酸仍是痤疮治疗的"金标准"，近年来提出的低剂量异维a酸疗法可在不降低疗效的同时，显著减少皮肤干燥等副作用。2018年FDA批准了Seysara（sarecycline），用于治疗9岁及以上患者的非结节性中度至重度寻常痤疮的炎症性病变，该药对痤疮丙酸杆菌更具针对性，且对肠道菌群影响较小，安全性更优。为应对耐药性问题，新型疗法不断涌现。研究发现1A1型菌株高表达促炎因子CAMP2，注射于皮损部位的靶向CAMP的疫苗有望成为新的治疗方法42,43。除此之外，基于CRISPR-Cas的微生物组精准编辑技术通过噬菌体递送系统，或可选择性清除皮肤微生物组中的特定致病菌株。该技术利用核酸酶特异性识别并切割目标细菌的基因组序列，可精准清除致病菌株而不影响共生菌群。这种创新方法为痤疮治疗提供了微生物组层面的精准调控策略，既可治疗现有炎症症状，又能从根源上预防疾病发生。对于特殊人群，锌制剂可用于孕妇痤疮的抗炎治疗，而女性患者可选择复方口服避孕药，其疗效与口服抗生素相当，有助于减少抗生素滥用44。专家简介鞠强主任医师上海交通大学医学院附属仁济医院主任医师、博士生导师上海交通大学医学院附属仁济医院皮肤科主任上海市医学会皮肤科分会副主任委员中国医师协会皮肤科医师分会常务委员兼痤疮学组组长中国研究型医院学会皮肤科学专业委员会副主任委员中国人体健康促进会皮肤科分会秘书长中国康复学会皮肤科分会副会长兼痤疮学组组长中国中西医结合学会皮肤性病专业委员会常务委员中国非公医疗机构协会皮肤科分会常务委员兼痤疮学组组长中国整形协会皮肤美容分会常务委员上海市卫生系统优秀学科带头人“新百人” Dermatology助理编委，中华皮肤科杂志、实用皮肤科杂志及中国中西医结合皮肤病杂志编委。参考文献 1.Tan JKL, Bhate K. 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Efficacy and safety of topical minocycline foam (FMX101 4%) in treatment of Chinese subjects with moderate-to-severe facial acne vulgaris: A phase 3, multi-centre, randomized, double-blind, vehicle-controlled study. J Eur Acad Dermatol Venereol. 2025 May;39(5):967–75. 22. Zhu C, Wei B, Li Y, Wang C. Antibiotic resistance rates in Cutibacterium acnes isolated from patients with acne vulgaris: a systematic review and meta-analysis. Front Microbiol. 2025;16:1565111. 23. He L, Wu WJ, Yang JK, Cheng H, Zuo XB, Lai W, et al. Two new susceptibility loci 1q24.2 and 11p11.2 confer risk to severe acne. Nat Commun. 2014;5:2870. 24. Qiu X, Feng Y, Mo X, Ju Q. Multi-omics Analysis Identifies Genetic Mechanisms and Therapeutic Targets for Acne Vulgaris. J Invest Dermatol. 2025 May 19;S0022-202X(25)00487-7. 25. Tomida S, Nguyen L, Chiu BH, Liu J, Sodergren E, Weinstock GM, et al. Pan-genome and comparative genome analyses of propionibacterium acnes reveal its genomic diversity in the healthy and diseased human skin microbiome. mBio. 2013 Apr 30;4(3):e00003-00013. 26. T Y, X X, Y L, X W, S W, Z Q, et al. Multi-omics signatures reveal genomic and functional heterogeneity of Cutibacterium acnes in normal and diseased skin. Cell host & microbe [Internet]. 2024 Oct 7 [cited 2025 Sept 10];32(7). Available from: https://pubmed.ncbi.nlm.nih.gov/38936370/ 27. 毛囊皮脂腺微生态与痤疮. 实用皮肤病学杂志. 2019;(02 vo 12):94-97+101. 28. Almoughrabie S, Cau L, Cavagnero K, O’Neill AM, Li F, Roso-Mares A, et al. Commensal Cutibacterium acnes induce epidermal lipid synthesis important for skin barrier function. Sci Adv. 2023 Aug 18;9(33):eadg6262. 29. Goodarzi A, Mozafarpoor S, Bodaghabadi M, Mohamadi M. The potential of probiotics for treating acne vulgaris: A review of literature on acne and microbiota. Dermatol Ther. 2020 May;33(3):e13279. 30. Karoglan A, Paetzold B, Pereira de Lima J, Brüggemann H, Tüting T, Schanze D, et al. Safety and Efficacy of Topically Applied Selected Cutibacterium acnes Strains over Five Weeks in Patients with Acne Vulgaris: An Open-label, Pilot Study. Acta Derm Venereol. 2019 Dec 1;99(13):1253–7. 31. Kim HJ, Lee YS, Lee BS, Han CH, Kim SG, Kim CH. NLRP3 inflammasome activation and NETosis positively regulate each other and exacerbate proinflammatory responses: implications of NETosis inhibition for acne skin inflammation treatment. Cell Mol Immunol. 2024 May;21(5):466–78. 32. Mattii M, Lovászi M, Garzorz N, Atenhan A, Quaranta M, Lauffer F, et al. Sebocytes contribute to skin inflammation by promoting the differentiation of T helper 17 cells. Br J Dermatol. 2018 Mar;178(3):722–30. 33. O’Neill AM, Liggins MC, Seidman JS, Do TH, Li F, Cavagnero KJ, et al. Antimicrobial production by perifollicular dermal preadipocytes is essential to the pathophysiology of acne. Sci Transl Med. 2022 Feb 16;14(632):eabh1478. 34. Cao K, Chen G, Chen W, Hou X, Hu T, Lu L, et al. Formalin-killed Propionibacterium acnes activates the aryl hydrocarbon receptor and modifies differentiation of SZ95 sebocytes in vitro. Eur J Dermatol. 2021 Feb 1;31(1):32–40. 35. 鞠强, 李嘉祺. 寻常痤疮再认识：从发病机制到治疗策略. 中华皮肤科杂志. 2024 Apr 15;57(04):289–94. 36. Picardo M, Cardinali C, La Placa M, Lewartowska-Białek A, Lora V, Micali G, et al. Efficacy and safety of N-acetyl-GED-0507-34-LEVO gel in patients with moderate-to severe facial acne vulgaris: a phase IIb randomized double-blind, vehicle-controlled trial. Br J Dermatol. 2022 Oct;187(4):507–14. 37. Cao W yu, Zhao H qing, Gu X, Shao W jun, Zheng L jie, Zeng Q ya, et al. Light-responsive antibacterial dissolving microneedles loaded with 5-aminolevulinic acid and silver nanoparticles for the treatment of acne. International Journal of Pharmaceutics. 2024 Dec 25;667:124961. 38. Xiang Y, Lu J, Mao C, Zhu Y, Wang C, Wu J, et al. Ultrasound-triggered interfacial engineering-based microneedle for bacterial infection acne treatment. Sci Adv. 9(10):eadf0854. 39. Pariser DM, Eichenfield LF, Bukhalo M, Waterman G, Jarratt M, PDT Study Group. Photodynamic therapy with methyl aminolaevulinate 80 mg g(-1) for severe facial acne vulgaris: a randomized vehicle-controlled study. Br J Dermatol. 2016 Apr;174(4):770–7. 40. Zhang L, Yang Y, Wang B, Zhao Y, Wang P, Liu J, et al. Modified red light 5-aminolevulinic acid photodynamic therapy versus low-dose isotretinoin therapy for moderate to severe acne vulgaris: A prospective, randomized, multicenter study. J Am Acad Dermatol. 2023 Dec;89(6):1141–8. 41. Panchaprateep R, Munavalli G. Low-fluence 585 nm Q-switched Nd:YAG laser: a novel laser treatment for post-acne erythema. Lasers Surg Med. 2015 Feb;47(2):148–55. 42. Valanne S, McDowell A, Ramage G, Tunney MM, Einarsson GG, O’Hagan S, et al. CAMP factor homologues in Propionibacterium acnes: a new protein family differentially expressed by types I and II. Microbiology (Reading). 2005 May;151(Pt 5):1369–79. 43. Wang Y, Hata TR, Tong YL, Kao MS, Zouboulis CC, Gallo RL, et al. The Anti-Inflammatory Activities of Propionibacterium acnes CAMP Factor-Targeted Acne Vaccines. J Invest Dermatol. 2018 Nov;138(11):2355–64. 44. Dréno B. [The treatment of acne]. Presse Med. 2005 Apr 9;34(7):540–3. 撰稿丨阮丹丹、杨雪帆、邱欣澜审校丨鞠强排版丨叶子点击“阅读原文” 解锁您的“优麦拾光纪念册”

临床研究

2023-01-26

·BioSpace

Nogra Pharma announces out-licensing agreement with Torii Pharmaceutical for Japan for New Chemical Entity topical acne treatment

Nogra Pharma announces out-licensing agreement with Torii Pharmaceutical for Japan for New Chemical Entity topical acne treatment NAC-GED-0507 is aPhase III-ready New Chemical Entity (NCE), potentialfirst-in-class treatment, selective PPARγ modulator for topical treatment of acne Phase IIb trial demonstrated a superior safety and efficacy profile compared to standard of care. Results were published in the British Journal of Dermatology in October 2022 Dublin, Ireland, 26 January 2023, Nogra Pharma (“Nogra” or “the Company”), a clinical stage biotechnology company developing innovative therapeutics for immune-inflammatory-mediated diseases, today announces it has entered into an out-licensing agreement with Torii Pharmaceutical Co., Ltd. (Torii) (TSE:4551), to further develop and commercialise NAC-GED-0507 in Japan for the treatment of acne vulgaris. Under the agreement, [for which financial terms are not being disclosed], Torii Pharmaceuticals will gain exclusive development and commercialisation rights for NAC-GED-0507 in Japan. NAC-GED-0507 is an IP protected, Phase III-ready, small molecule selective modulator of the peroxisome proliferation-activated receptor γ (PPARγ), which has been developed by Nogra Pharma in a gel formulation, ideal for topical treatment of acne vulgaris. NAC-GED-0507 has a novel mechanism of action, which acts on the primary pathogenetic factors of acne, with demonstrated: anti-inflammatory activity in both sebocytes and keratinocytes, sebogenesis-modulating activity in sebocytes, capability to “normalize” keratinocytes proliferation/differentiation process, altered by pro-inflammatory cytokines, and effect of induction of sebocytes differentiation. The late-stage clinical development plan has been agreed with the US Food & Drug Administration (FDA) and the European Medicines Agency (EMA). Acne vulgaris is a skin condition that affects 85% of the adolescent and young adult population and is one of the most common skin diseases, with an estimated global prevalence (for all ages) of nearly 10% of the population 1. Despite its high prevalence, innovation in the space has been limited in recent years with NAC-GED-0507 being the first innovative treatment, based on its pharmacological properties, developed in the last 25 years. Leopoldo Zambeletti, Director of Nogra Pharma Ltd, commented: “The agreement with Torii Pharmaceuticals is a testament to the high quality of our scientific network and our development and formulation expertise.At Nogra Pharma, we are committed to using this expertise to develop novel therapeutics agents for the treatment of immune-inflammatory-mediated diseases with high unmet medical need and this agreement is a good step towards this goal. “We’re particularly excited to be exploring innovative pathways in acne, a significant unmet need.If approved, NAC-GED-0507 will be the first new drug for acnein decades,which acts via a novel mechanism of action and has the potential to be the first “disease-modifying agent” for millions of patients affected by the condition worldwide. We’re delighted to be working with Torii, which has a leading position and reputation in dermatology, and look forward to progressing this molecule into development.” Goichi Matsuda, Representative Director, President and Chief Executive Officer of Torii, commented:“We are excited to partner with Nogra and add NAC-GED-0507 to Torii’s growing portfolio of products to treat dermatologic skin diseases with significant unmet need. “The development of NAC-GED-0507 for the treatment of acne is a unique and new approach. Given the promising clinical data, we are confident that NAC-GED-0507 will provide a new treatment option for acne patients. We look forward to collaborating with Nogra and developing NAC-GED-0507 for the Japanese market.” A double-blinded, randomised, vehicle-controlled, multi-centre Phase IIb study conducted on 450 patients with moderate-to-severe acne (registered on EudraCT 2018‐003307‐19) demonstrated statistically superior efficacy of NAC-GED-0507 5% gel over placebo (p < 0.0001) in terms of IGA success rate and total lesion count and was well tolerated. Results of the study, which were published in the British Journal of Dermatology in October 2022, can be found here. - Ends – References J.K.L. Tan, K. Bhate: A global perspective on the epidemiology of acne. British Journal of Dermatology (2015)172(Suppl. 1), pp 3–12 Nogra Pharma Ltd Consilium Strategic Communications Leopoldo Zambeletti Director Phone: +44 7788 183112 Email: lz@nographarma.com Jessica Hodgson/Stella Lempidaki/Andrew Stern Phone: +44 (0)20 3709 5700 Email: nogra@consilium-comms.com About Nogra Pharma Nogra Pharma is a private, clinical stage biotechnology company developing innovative therapeutics for immune-inflammatory-mediated diseases. Led by a highly experienced team with expertise in drug development, Nogra Pharma in collaboration with its subsidiary PPM Services, identifies high-value targets and develops innovative medicines through partnerships with world-leading academic partners. Through a deep understanding of immuno-inflammation, combined with formulation and manufacturing expertise the Company has generated a promising, diversified, commercial pipeline comprising three highly differentiated technology platforms, which can yield multiple assets in a range of indications with high unmet medical need. The oligonucleotide platform has yielded the first oral formulation in the drug class for the treatment of inflammatory bowel disease (an antisense oligonucleotide to Smad7 mRNA which will re-enter clinical development under Nogra’s lead), while the small molecule platforms AhR and SPARMM have yielded promising candidates for the treatment of immune-inflammatory conditions and fibrosis, in skin, gastrointestinal and pulmonary disease. Headquartered in Dublin, Ireland, the Company operates a lean business model of early drug development, up to Phase IIb, before outsourcing assets to pharma partners. About Torii Pharmaceutical Torii Pharmaceutical Co., Ltd. operate business from day to day in line with Torii Pharmaceutical’s Purpose: “We are committed to sincerely serving patients, their families, and those involved in medical care. We contribute to the healthy recovery of patients, as well as to a happy, enriched life free from fear of illness. We will flexibly change and adapt to meet the needs of the times and the environment, while retaining the trust we have earned over our long history, and we will continue to take on the challenge of contributing to healthcare that only we can make.” Torii focuses on Renal diseases, Hemodialysis, Allergy and Skin diseases as its therapeutic areas of importance. Torii is a member of Japan Tobacco Inc. (JT) group. Collaboration with JT takes the form of functional focus, with JT undertaking R&D on new compounds and Torii integrating manufacture and marketing. In addition to Torii’s independent activities, Torii‘s partnership with JT includes in-licensing of high-quality pharmaceuticals.

临床2期临床结果引进/卖出临床1期

100 项与 GED-0507-34 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16109

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适应症	最高研发状态	国家/地区	公司	日期
寻常痤疮	临床3期	意大利	PPM Insurance Services, Inc.	2024-11-19
寻常痤疮	临床3期	波兰	PPM Insurance Services, Inc.	2024-11-19
寻常痤疮	临床3期	西班牙	PPM Insurance Services, Inc.	2024-11-19
痤疮样疹	临床3期	爱尔兰	Nogra Pharma Ltd.	2022-01-30
溃疡性结肠炎	临床2期	美国	SM2 Software & Services Management SA	2016-11-28
溃疡性结肠炎	临床2期	保加利亚	SM2 Software & Services Management SA	2016-11-28
溃疡性结肠炎	临床2期	加拿大	SM2 Software & Services Management SA	2016-11-28
溃疡性结肠炎	临床2期	法国	SM2 Software & Services Management SA	2016-11-28
溃疡性结肠炎	临床2期	匈牙利	SM2 Software & Services Management SA	2016-11-28
溃疡性结肠炎	临床2期	意大利	SM2 Software & Services Management SA	2016-11-28

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02808390 (SEGMENT, CTgov)	临床2期	溃疡性结肠炎	19	GED-0507-34-Levo 80 mg (80 mg BID)	遞製夢簾築膚糧衊憲艱(鹽築夢淵壓鹽窪積積蓋) = 衊蓋衊糧醖齋窪鏇鬱窪鑰遞選選鑰廠廠鏇觸糧 (衊衊餘夢築觸積繭遞夢, 觸膚餘獵糧構壓鹹獵構 ~ 積艱廠壓餘夢艱觸鑰積) 更多	-	2018-10-31
				GED-0507-34-Levo 160 mg (160 mg BID)	遞製夢簾築膚糧衊憲艱(鹽築夢淵壓鹽窪積積蓋) = 餘糧選鏇觸廠廠憲衊獵鑰遞選選鑰廠廠鏇觸糧 (衊衊餘夢築觸積繭遞夢, 鏇獵網夢窪壓壓繭繭餘 ~ 遞鏇壓網鹽蓋鏇襯憲蓋) 更多