A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults with Mild to Moderate Atopic Dermatitis

开始日期2019-12-05

申办/合作机构

UNION Therapeutics A/S

EUCTR2019-002771-33-BG / Not yet recruiting临床2期

开始日期2019-10-25

申办/合作机构

UNION Therapeutics A/S

NCT04339985 / Completed临床2期

A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate Atopic Dermatitis

This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis

开始日期2019-10-22

申办/合作机构

UNION Therapeutics A/S

100 项与 ATX-201 相关的临床结果

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100 项与 ATX-201 相关的转化医学

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100 项与 ATX-201 相关的专利（医药）

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项与 ATX-201 相关的文献（医药）

2022-05-01·Clinical and Translational Medicine2区 · 医学

Targeting the cutaneous microbiota in atopic dermatitis: ‘A new hope’ or ‘attack of the CoNS’?

2区 · 医学

ArticleOA

作者: Chu, Chia‐Yu

AbstractAlthough evidence showing that Staphylococcus aureus (S. aureus) is directly causative of atopic dermatitis (AD) is still lacking, there is evidence that S. aureus abundance is associated with disease flares and therapeutic responses. Patients receiving ATx201 OINTMENT 2% twice‐daily had a significant reduction in the abundance of S. aureus and increasing Shannon diversity of skin microbiome compared to vehicle after seven days. A small molecule with a narrow‐spectrum effect, especially on S. aureus, might be an attractive alternative for the treatment of AD.

2022-05-01·Clinical and Translational Medicine2区 · 医学

Topical niclosamide (ATx201) reduces Staphylococcus aureus colonization and increases Shannon diversity of the skin microbiome in atopic dermatitis patients in a randomized, double‐blind, placebo‐controlled Phase 2 trial

2区 · 医学

ArticleOA

作者: M'Zali, Fatima ; Friis, Christian ; Westh, Henrik ; Guttman‐Yassky, Emma ; Hansen, Jon U. ; Stingl, Georg ; Bangert, Christine ; Nussbaumer‐Pröll, Alina ; Sommer, Morten ; Nielsen, Henrik Bjørn ; Matzneller, Peter ; Bauer, Martin ; Pace, John ; Nielsen, Hanne Mørck ; Kim, Wooseong ; Mylonakis, Eleftherios ; Rades, Thomas ; Simon, Daniel ; Johansen, Helle Krogh ; Zeitlinger, Markus ; Lagler, Heimo ; Sørensen, Nikolaj ; Guardabassi, Luca ; Priemel, Petra ; Butty, Pascal ; Quint, Tamara ; Weiss, Anne ; Toft‐Kehler, Rasmus ; Delavenne, Emilie ; Matias, Carina ; Jana, Bimal ; Li, Ping ; Eberl, Sabine ; dos Santos, Teresa Pires ; Weber, Maria ; Lundberg, Carina Vingsbo ; Anne Österreicher, Zoe

AbstractBackgroundIn patients with atopic dermatitis (AD), Staphylococcus aureus frequently colonizes lesions and is hypothesized to be linked to disease severity and progression. Treatments that reduce S. aureus colonization without significantly affecting the skin commensal microbiota are needed.Methods and findingsIn this study, we tested ATx201 (niclosamide), a small molecule, on its efficacy to reduce S. aureus and propensity to evolve resistance in vitro. Various cutaneous formulations were then tested in a superficial skin infection model. Finally, a Phase 2 randomized, double‐blind and placebo‐controlled trial was performed to investigate the impact of ATx201 OINTMENT 2% on S. aureus colonization and skin microbiome composition in patients with mild‐to‐severe AD (EudraCT:2016‐003501‐33). ATx201 has a narrow minimal inhibitory concentration distribution (.125–.5 μg/ml) consistent with its mode of action – targeting the proton motive force effectively stopping cell growth. In murine models, ATx201 can effectively treat superficial skin infections of methicillin‐resistant S. aureus. In a Phase 2 trial in patients with mild‐to‐severe AD (N = 36), twice‐daily treatment with ATx201 OINTMENT 2% effectively reduces S. aureus colonization in quantitative colony forming unit (CFU) analysis (primary endpoint: 94.4% active vs. 38.9% vehicle success rate, p = .0016) and increases the Shannon diversity of the skin microbiome at day 7 significantly compared to vehicle.ConclusionThese results suggest that ATx201 could become a new treatment modality as a decolonizing agent.

100 项与 ATX-201 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB05765

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
阿尔茨海默症	临床2期	波兰	UNION Therapeutics A/S	2019-10-22
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轻度特应性皮炎	临床2期	丹麦	UNION Therapeutics A/S	2019-10-22
光化性角化病	临床2期	-	Novartis Pharma AG	-
光化性角化病	临床2期	-	Moon Collider Ltd.	-
阿尔茨海默症	临床1期	保加利亚	UNION Therapeutics A/S	2019-10-22
脓疱疮	临床1期	南非	UNION Therapeutics A/S	2018-02-23
中度特应性皮炎	临床1期	加拿大	UNION Therapeutics A/S	2017-09-25
阿尔茨海默症	药物发现	丹麦	UNION Therapeutics A/S	2019-10-22
细菌感染	药物发现	奥地利	UNION Therapeutics A/S	2016-12-01