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更新于：2025-11-26
MORF-057
更新于：2025-11-26
概要
基本信息
非在研机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)临床2期 |
特殊审评- |
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关联
6
项与 MORF-057 相关的临床试验NCT07186101
A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis
NCT06964776
A Phase 1 Study to Further Investigate the Pharmacokinetics, Safety and Tolerability, Food Effect and Drug-Drug Interaction of LY4268989 (MORF-057) in Healthy Participants
NCT06226883
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 2 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)
100 项与 MORF-057 相关的临床结果
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100 项与 MORF-057 相关的转化医学
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100 项与 MORF-057 相关的专利（医药）
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2
项与 MORF-057 相关的文献（医药）2025-08-01Clinical Gastroenterology and Hepatology
A Phase 2 Study of MORF-057, an Oral α4β7 Integrin Inhibitor in Moderately to Severely Active Ulcerative Colitis
Article
作者: Singhal, Prabhat ; Peyrin-Biroulet, Laurent ; Soo, Carolyn ; Choi, Michael Y ; Mangada, Maloy ; Sands, Bruce E ; Abhyankar, Brihad ; Rogers, Bruce N ; Hussain, Ali ; Kierkus, Jarosław ; Cui, Dan ; Lee, Dooyoung ; Wu, Yujun ; Schreiber, Stefan ; Danese, Silvio ; Feagan, Brian G ; Sun, Fangui
BACKGROUND & AIMS:
MORF-057 is an orally administered small-molecule drug that inhibits α4β7 integrin-mediated recruitment of α4β7-expressing lymphocytes to the gut, a process implicated in the pathology of ulcerative colitis (UC). This study evaluated the efficacy, pharmacokinetics, pharmacodynamics, safety, and tolerability of MORF-057 in participants with moderately to severely active UC.
METHODS:
This open-label, phase 2a, single-arm, multicenter trial comprised a 6-week screening period, a 52-week active treatment period (including a 12-week induction period and 40-week maintenance period), and a 4-week safety follow-up period. Of the 35 participants enrolled in the main cohort, 18 participants received 100 mg of oral MORF-057 twice daily for the entire treatment period. The primary efficacy endpoint was a change in the Robarts Histopathology Index (RHI) score from baseline to week 12 and was assessed in all participants with evaluable data. Additional clinical, endoscopic, and histological variables were assessed at screening and at weeks 12 and 52.
RESULTS:
MORF-057 was well tolerated, and no treatment-emergent serious adverse events were observed. At week 12, participants (n = 35) exhibited a mean change from baseline in RHI score of -6.4 (standard deviation, 11.2). Additionally, 22.9% of participants (8/35) achieved RHI remission (RHI score ≤3). In participants with evaluable data (n = 18), the effects of MORF-057 on pharmacokinetics, pharmacodynamics, and clinical efficacy were achieved at week 12 and remained consistent to week 52.
CONCLUSION:
Overall, this study demonstrated that oral MORF-057 is well tolerated, with promising efficacy for individuals with moderately to severely active UC.
CLINICALTRIALS:
gov, Number: NCT05291689.
2025-07-01CURRENT OPINION IN GASTROENTEROLOGY
Gut-directed therapeutics in inflammatory bowel disease
Review
作者: Ciorba, Matthew A. ; Curiel, David T. ; Kratschmer, Christina
Purpose of review:
Tissue-directed therapies (TDTs) provide potential advantages, including improved tolerance, safety, and efficacy. This review provides a conceptual framework for understanding intestinal TDT and summarizes the current landscape of TDT in inflammatory bowel disease (IBD).
Recent findings:
Vedolizumab, a mAb targeting the gut homing α4β7 integrin, served as revolutionary proof-of-principle for the power of advanced TDT in IBD. The development of other monoclonal antibodies targeting cell adhesion molecules followed including abrilumab (α4β7), etrolizumab (β7), and ontamalimab (MAdCAM-1). MORF-057, an oral small molecule inhibitor of α4β7, is now in development for ulcerative colitis. Efforts have also been made toward gut specific JAK inhibitors. Microbiome-based therapies, including engineered probiotics, bacteriophages, and postbiotics, are gaining interest. There are also a number of innovative drug delivery methods, including engineered yeast, hydrogels, and nanoparticles, and viral-based gene therapy.
Summary:
Gut-targeted therapies range from novel variations on traditional drugs (i.e., mAbs and small molecules) to microbiome-based therapeutics and engineered delivery systems. They can be used alone or in combination with currently available therapies. Future directions should focus on the development of tried-and-true modalities (mAbs, small molecules) as well as the microbiome and more innovative delivery systems.
100 项与 MORF-057 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 克罗恩病 | 临床2期 | 美国 | 2024-07-18 | |
| 克罗恩病 | 临床2期 | 日本 | 2024-07-18 | |
| 克罗恩病 | 临床2期 | 奥地利 | 2024-07-18 | |
| 克罗恩病 | 临床2期 | 巴西 | 2024-07-18 | |
| 克罗恩病 | 临床2期 | 加拿大 | 2024-07-18 | |
| 克罗恩病 | 临床2期 | 哥伦比亚 | 2024-07-18 | |
| 克罗恩病 | 临床2期 | 克罗地亚 | 2024-07-18 | |
| 克罗恩病 | 临床2期 | 捷克 | 2024-07-18 | |
| 克罗恩病 | 临床2期 | 法国 | 2024-07-18 | |
| 克罗恩病 | 临床2期 | 德国 | 2024-07-18 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 39 | 築範醖獵網範鹽願膚壓(鏇範網餘製製鏇願膚襯) = 網齋餘鬱糧醖膚鹹鏇憲 積醖選構鬱憲網製淵蓋 (遞鏇糧蓋範獵觸窪鹽願, 11.18) 更多 | - | 2024-11-26 | |||
临床2期 | - | 壓襯鹽遞願積夢繭築繭(膚築鏇夢顧顧憲製鑰積) = 積構鏇窪廠醖膚壓餘範 壓窪鑰衊淵糧觸繭觸繭 (糧窪遞鏇蓋襯範糧壓憲 ) 达到 更多 | 积极 | 2023-11-03 | |||
N/A | - | MORF-057 100 mg BID | 構範襯範鑰遞鏇繭糧構(鏇蓋鬱膚築積醖範選獵) = anemia in 3 (8.6%) patients 膚簾鑰膚壓鹹餘願選觸 (鬱願鬱壓遞製鹹壓範艱 ) 更多 | - | 2023-10-15 | ||
临床1期 | - | 33 | 繭餘鏇鏇選壓蓋淵選製(積簾顧顧遞簾積簾積膚) = The percent change of ITGβ7+CD19+ BSM cells from baseline was significantly greater for all dose groups compared to PBO 壓淵壓鑰鹽製獵積願蓋 (鹽願鏇壓觸齋鏇網獵鬱 ) | 积极 | 2022-10-08 | ||
Placebo |
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