TOP-1630(TOP-1630) - 药物靶点：LCK x SRC x Syk x p38 MAPK_在研适应症：干眼症_专利_临床

概要

基本信息

药物类型

小分子化药

别名

靶点

LCK x SRC x Syk x p38 MAPK

作用机制

LCK抑制剂(酪氨酸蛋白激酶LCK抑制剂)、SRC抑制剂(酪氨酸蛋白激酶SRC抑制剂)、Syk抑制剂(脾酪氨酸激酶抑制剂)

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治疗领域

眼部疾病

在研适应症

干眼症

非在研适应症-

原研机构

TopiVert Ltd.

在研机构

TopiVert Ltd.

非在研机构

Topivert Pharma Ltd.

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 TOP-1630 相关的临床试验

NCT03833388

/ Completed临床2/3期

A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of TOP1630 0.1% Ophthalmic Solution Compared to Placebo in Subjects With Moderate to Severe Dry Eye Syndrome

In subjects with Dry Eye Syndrome (DES):
The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.

开始日期2019-02-13

申办/合作机构

Topivert Pharma Ltd.

NCT03088605

/ Completed临床2期

A Single-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of TOP1630 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Syndrome

In subjects with Dry Eye Syndrome:
The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo.
The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.

开始日期2017-02-20

申办/合作机构

北京橙鑫数据科技有限公司

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100 项与 TOP-1630 相关的临床结果

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100 项与 TOP-1630 相关的转化医学

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100 项与 TOP-1630 相关的专利（医药）

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1

项与 TOP-1630 相关的文献（医药）

Clinical Ophthalmology

<p>A phase 2 randomized, double-masked, placebo-controlled study of novel nonsystemic kinase inhibitor TOP1630 for the treatment of dry eye disease</p>

Article

作者: Webber, Steve ; Walshe, Claire ; Torkildsen, Gail ; Ousler, George ; Fyfe, Matthew C T ; Taylor, Mike ; Sheppard, John D ; Rowley, Adele ; Duggal, Ajay

PURPOSETo evaluate the safety and efficacy of topical TOP1630, a novel nonsystemic kinase inhibitor, in dry eye disease (DED).PATIENTS AND METHODSA randomized, double-masked, parallel-group trial of 0.1% TOP1630 ophthalmic solution TID or placebo (vehicle without active drug) was conducted in DED subjects (n=61). Key eligibility criteria consistent with enrolling a moderate to severe DED population included >6 months DED history; OSDI^© score ≥18; Schirmer's test score ≤10 and ≥1 mm/5 minutes; tear film break-up time >1 and <7 seconds; and dry eye exacerbation in corneal staining and ocular discomfort in a Controlled Adverse Environment (CAE^®). After a 7-day run-in period with placebo TID, eligible subjects were randomized to TOP1630 or placebo for 28 days. No supplemental artificial tears or rescue medication were allowed.RESULTSTOP1630 was safe, well-tolerated, and efficacious in treating DED symptoms and signs. No serious adverse events (AEs) or withdrawals due to treatment emergent AEs occurred. Drop comfort scores showed TOP1630 to be comfortable and comparable with placebo. Significant symptom improvements were seen for TOP1630 vs placebo for ocular discomfort (P=0.02 post-CAE), grittiness/foreign body sensation (on four independent assessment scales, each P<0.05), worst DED symptom (diary, P=0.06), and ocular pain (VAS, P=0.03). Sign improvements were seen for total ocular surface (all regions), corneal sum, and conjunctival sum staining with TOP1630 compared with placebo (each P<0.05).CONCLUSIONTOP1630 had placebo-like tolerability and produced improvements in multiple symptom and sign endpoints in both environmental and challenge settings. The emergent TOP1630 benefit-risk profile for DED treatment is highly favorable and supports further development.

100 项与 TOP-1630 相关的药物交易

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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
干眼综合征	临床3期	美国	Topivert Pharma Ltd.	2019-02-13
干眼综合征	临床3期	美国	TopiVert Ltd.	2019-02-13
干眼症	临床3期	-	TopiVert Ltd.	-

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临床结果

适应症

分期

评价

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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


NCT03088605 (CTgov)	临床2期	干眼综合征	69	TOP1630 Ophthalmic Solution (Active)	夢顧願鏇範築窪築選壓(壓膚齋網構鹽襯壓夢鹹) = 顧願築鑰壓願憲襯廠襯簾製餘積襯憲範繭醖壓 (膚範淵顧廠繭窪糧簾範, 淵範鬱鹽齋繭築鹹網鬱 ~ 糧鏇構積艱襯簾鏇製衊) 更多	-	2024-02-14
				Placebo to TOP1630 Ophthalmic Solution (Placebo)	夢顧願鏇範築窪築選壓(壓膚齋網構鹽襯壓夢鹹) = 選構構淵憲艱淵襯衊夢簾製餘積襯憲範繭醖壓 (膚範淵顧廠繭窪糧簾範, 選鬱憲襯襯鏇淵窪獵鹹 ~ 衊鬱夢願夢糧廠願構簾) 更多
NCT03088605 (Pubmed) 人工标引	临床2期	干眼综合征	61	TOP1630	(窪壓廠鏇鹹廠願獵鹹醖): P-Value = <0.05 更多	积极	2019-02-12
				Placebo