A Phase 2, Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects With Mild to Moderate Ulcerative Colitis (UC)

The study will assess the efficacy and safety of oral MT-1303 compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC), as well as maintenance treatment with open-label MT-1303 for up to 36 weeks.

开始日期2021-09-29

申办/合作机构

Bausch Health Americas, Inc.

EUCTR2020-005232-30-BG / Not yet recruiting临床2期

A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC)

开始日期2021-06-22

申办/合作机构

Salix Pharmaceuticals, Inc.

NCT02389790 / Completed临床2期

A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 Study

The primary objectives of the study are:
-To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）

开始日期2015-08-01

申办/合作机构

Mitsubishi Tanabe Pharma Corp.

100 项与 Amiselimod hydrochloride 相关的临床结果

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100 项与 Amiselimod hydrochloride 相关的转化医学

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100 项与 Amiselimod hydrochloride 相关的专利（医药）

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项与 Amiselimod hydrochloride 相关的文献（医药）

2023-03-01·Clinical pharmacology in drug development

A Randomized, Double‐Blind, Parallel Design Thorough QT Study With a Nested Crossover to Compare the Cardiac Safety of Amiselimod With Placebo and Positive Control in Healthy Volunteers

Article

作者: Lester, Robert ; Lee, Jimin ; Israel, Robert J. ; Franklin, Howard ; Lowe, Ezra R. ; O'Reilly, Terry ; Slatkin, Neal E.

Abstract:

This double‐blind study evaluated the cardiac safety of amiselimod. Healthy adults (n = 190) were randomized (2:1:1) to receive (1) oral placebo (day −1), followed by oral amiselimod (days 1–26), which was upwardly titrated from 0.4 to 1.6 mg once daily to achieve steady‐state concentrations comparable with 0.4 (therapeutic) and 0.8 mg (supratherapeutic) once daily, and placebo (day 27); (2) placebo (day −1), oral moxifloxacin 400 mg (day 1; positive control), followed by placebo (days 1–27); or (3) placebo (days −1 to 26), followed by moxifloxacin 400 mg (day 27). No participant had a corrected QT interval by Fredericia (QTcF) >500 milliseconds or a change from baseline (dQTcF) >60 milliseconds. The upper limits of the 90%CIs for the differences in least‐squares mean difference in dQTcF between amiselimod and placebo on days 13 and 26 were <10 milliseconds. Area under the concentration‐time curve from 0 to 23.5 hours after dosing and maximum plasma concentration of amiselimod and amiselimod‐P (active metabolite) at steady‐state concentrations for the 0.8‐mg dose on day 26 were approximately double that observed with the 0.4‐mg dose on day 13. All adverse events were mild to moderate in severity, and no deaths occurred. Amiselimod did not have any clinically relevant effect on the QTcF interval.

2023-01-01·Frontiers in immunology

Modulating sphingosine 1-phosphate receptor signaling skews intrahepatic leukocytes and attenuates murine nonalcoholic steatohepatitis.

Article

作者: Fredrickson, Gavin ; Revelo, Xavier S ; Graham, Rondell P ; Song, Myeong Jun ; Dasgupta, Debanjali ; Nakao, Yasuhiko ; Mauer, Amy S ; Barrow, Fanta ; Malhi, Harmeet ; Venkatesan, Nanditha ; Liao, Chieh-Yu ; Sehrawat, Tejasav S

Sphingosine 1-phosphate (S1P) is a bioactive sphingolipid associated with nonalcoholic steatohepatitis (NASH). Immune cell-driven inflammation is a key determinant of NASH progression. Macrophages, monocytes, NK cells, T cells, NKT cells, and B cells variably express S1P receptors from a repertoire of 5 receptors termed S1P₁ - S1P₅. We have previously demonstrated that non-specific S1P receptor antagonism ameliorates NASH and attenuates hepatic macrophage accumulation. However, the effect of S1P receptor antagonism on additional immune cell populations in NASH remains unknown. We hypothesized that S1P receptor specific modulation may ameliorate NASH by altering leukocyte recruitment. A murine NASH model was established by dietary feeding of C57BL/6 male mice with a diet high in fructose, saturated fat, and cholesterol (FFC) for 24 weeks. In the last 4 weeks of dietary feeding, the mice received the S1P_1,4,5 modulator Etrasimod or the S1P₁ modulator Amiselimod, daily by oral gavage. Liver injury and inflammation were determined by histological and gene expression analyses. Intrahepatic leukocyte populations were analyzed by flow cytometry, immunohistochemistry, and mRNA expression. Alanine aminotransferase, a sensitive circulating marker for liver injury, was reduced in response to Etrasimod and Amiselimod treatment. Liver histology showed a reduction in inflammatory foci in Etrasimod-treated mice. Etrasimod treatment substantially altered the intrahepatic leukocyte populations through a reduction in the frequency of T cells, B cells, and NKT cells and a proportional increase in CD11b⁺ myeloid cells, polymorphonuclear cells, and double negative T cells in FFC-fed and control standard chow diet (CD)-fed mice. In contrast, FFC-fed Amiselimod-treated mice showed no changes in the frequencies of intrahepatic leukocytes. Consistent with the improvement in liver injury and inflammation, hepatic macrophage accumulation and the gene expression of proinflammatory markers such as Lgals3 and Mcp-1 were decreased in Etrasimod-treated FFC-fed mice. Etrasimod treated mouse livers demonstrated an increase in non-inflammatory (Marco) and lipid associated (Trem2) macrophage markers. Thus, S1P_1,4,5 modulation by Etrasimod is more effective than S1P₁ antagonism by Amiselimod, at the dose tested, in ameliorating NASH, likely due to the alteration of leukocyte trafficking and recruitment. Etrasimod treatment results in a substantial attenuation of liver injury and inflammation in murine NASH.

2022-06-24·Journal of Crohn's & colitis1区 · 医学

A phase II, Multicentre, Randomised, Double-Blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Efficacy of Amiselimod in Patients with Moderate to Severe Active Crohn’s Disease

1区 · 医学

Article

作者: Watanabe, Mamoru ; Davies, Martin ; Hibi, Toshifumi ; Danese, Silvio ; D’Haens, Geert

Abstract:

Background and Aims:

Amiselimod is an oral selective S1P1 receptor modulator with potentially fewer adverse effects than fingolimod. We evaluated the safety, tolerability, and clinical efficacy of amiselimod in participants with moderate to severe active Crohn’s disease.

Methods:

This was a phase IIa, multicentre, randomised, double-blind, parallel group, placebo-controlled study comparing amiselimod 0.4 mg with placebo over a 14-Week treatment period. The primary endpoint of the study was the proportion of participants with clinical response (Crohn’s Disease activity Index [CDAI] 100) from baseline at Week 12.

Results:

A total of 180 patients were screened and 78 were randomised [40 to amiselimod 0.4 mg and 38 to placebo]. There was no significant difference in the proportion of patients achieving CDAI 100 at Week 12 on amiselimod 0.4 mg and on placebo [48.7% vs. 54.1%, respectively] (odds ratio [OR] [95% confidence interval]: 0.79 [0.31, 1.98]). The results from the secondary endpoint analyses supported the results of the primary endpoint analysis. Treatment with amiselimod 0.4 mg was generally well tolerated, with 71.8% of participants completing the 14-week treatment period. Seven participants had serious adverse events and four discontinued treatment in the amiselimod group.

Conclusions:

Amiselimod 0.4 mg for 12 weeks was not superior to placebo for the induction of clinical response [CDAI 100] in Crohn’s disease. Treatment with amiselimod 0.4 mg was generally well tolerated and no new safety concerns related to amiselimod were reported in this study.

项与 Amiselimod hydrochloride 相关的新闻（医药）

2024-06-14

·BioSpace

Bausch Health Reports Promising R&D Trial Updates on Amiselimod and Scientific Data Presented at International Healthcare Conferences

LAVAL, QC / ACCESSWIRE / June 14, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global diversified pharmaceutical company enriching lives through a relentless drive to deliver better health outcomes, recently presented at two global healthcare conferences. Bausch Health's gastroenterology (GI) business, Salix Pharmaceuticals presented data from its Amiselimod clinical trials at Digestive Disease Week (DDW) 2024 during the IMIBD Late Breakers and Innovations in IBD session on May 19, 2024, in Washington, D.C., and post hoc pooled data analysis of Rifaximin at the International Liver Congress 2024™ (ILC 2024): Annual Meeting of the European Association for the Study of the Liver (EASL) on June 8, 2024 in Milan, Italy. Amiselimod at DDW Bausch Health shared positive late-breaking data from a global Phase 2 study evaluating Amiselimod for the treatment of patients with active, mild to moderate ulcerative colitis (UC) at Digestive Disease Week® (DDW) 2024. The data were presented by Dr. Steven Hanauer and Clifford Joseph Barborka, Professor of Medicine at Northwestern University. The randomized, double-blind, placebo-controlled trial investigated the efficacy and safety of Amiselimod over a 12-week treatment period. The results demonstrated that Amiselimod was well-tolerated and showed promise as a potential treatment for inducing remission in UC patients. Specifically: In the primary endpoint measure - both doses of Amiselimod (0.2mg and 0.4mg daily) led to a significantly greater improvement in Modified Mayo Score (MMS) compared to a placebo group on Day 85. This score reflects disease activity, with a lower score indicating better outcomes. Patients taking Amiselimod experienced an average improvement of -2.3 points, compared to -1.6 points in the placebo group (p-score <0.01) In the secondary measures, endoscopic improvement and clinical remission, after 12 weeks, a significantly higher proportion of patients receiving Amiselimod achieved endoscopic improvement (over 42%) compared to placebo (23%) with statistically significant difference (p-score <0.01). Similarly, over 31% of patients on Amiselimod experienced clinical remission compared to 18% in the placebo group (p-score = 0.03). In the safety evaluation patients were closely monitored for any adverse events throughout the 12 weeks. The findings concluded that Amiselimod treatment was well-tolerated. "Our recent trial results are a testament to the dedication and expertise of our research teams," said Dr. Tage Ramakrishna, Chief Medical Officer, President, R&D. "The promising data from this Amiselimod trial brings us closer to offering new, effective treatment to patients suffering from ulcerative colitis (UC). We are excited to advance this therapy to the next stage of development." Ulcerative colitis is a chronic disease affecting the large intestine, or colon. The condition causes inflammation and ulceration (sores) along the lining of the colon, which can lead to abdominal pain, cramps, bleeding and diarrhea.1 In ulcerative colitis, the inflammation starts at the rectum and continues through the colon. Symptoms include diarrhea with blood and mucus, pain on the left-hand side of the abdomen, urgency and tenesmus (the feeling of needing to pass stools even if the bowel is empty).1 Rifaximin at EASL At the European Association for the Study of the Liver (EASL) Conference, Bausch Health presented data comparing Rifaximin monotherapy to lactulose monotherapy in preventing overt hepatic encephalopathy (OHE) recurrence in cirrhosis patients with a history of OHE. This analysis, based on pooled data from two randomized trials (one phase 3 double-blind and one phase 4 open-label), focused on adult patients with cirrhosis and a history of OHE episodes showed that: Significantly fewer patients treated with Rifaximin monotherapy experienced an OHE episode compared with lactulose monotherapy (23.2% vs 49.0%, respectively; P<0.0001). Rifaximin monotherapy reduced the risk of a breakthrough OHE event by 60% versus lactulose monotherapy during 6 months of treatment. Rifaximin monotherapy was well tolerated. These data suggest Rifaximin monotherapy has the potential to be a viable treatment option for OHE recurrence risk reduction in appropriate patient populations. About Amiselimod Amiselimod is a sphingosine-1-phosphate (S1P) receptor functional antagonist and, by inhibiting the receptor function of the lymphocyte sphingosine-1-phosphate (S1P) receptor, retains lymphocytes sequestered in the lymph nodes and prevents them from contributing to autoimmune reactions.1 Due to this mechanism of action, Amiselimod may potentially be useful for various autoimmune diseases.2 Affinity to S1P1 and S1P5 receptor subtypes, suggests that Amiselimod could potentially have a more pronounced effect on ulcerative colitis related inflammation than compounds with restricted activity on S1P1 receptor subtype exclusively or combined activity on S1P1 and S1P5. 2 About XIFAXAN XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. About Salix Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and provide health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit and connect with us on Twitter and LinkedIn. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit and connect with us on LinkedIn. References 1 IBD Clinic, University of Alberta: 2 BiseraStepanovska, AndreaHuwiler. Targeting the S1P receptor signaling pathways as a promising approach for treatment of autoimmune and inflammatory diseases. Pharmacological Research. February 2019. The XIFAXAN 550 mg product and the XIFAXAN trademark are licensed by Alfasigma S.p.A to Salix Pharmaceuticals or its affiliates. ©2024 Salix Pharmaceuticals or its affiliates. Investor Contact: Garen Sarafian ir@bauschhealth.com (877) 281-6642 (toll-free) Media Contact: Kevin Wiggins corporate.communications@bauschhealth.com (908) 541-3785 SOURCE: Bausch Health Companies Inc. View the original press release on accesswire.com

临床结果临床2期临床3期

2024-06-14

·ir.bauschhealth.com

Bausch Health Reports Promising R&D Trial Updates on Amiselimod and Scientific Data Presented at International Healthcare Conferences

June 14, 2024 LAVAL, Quebec, June 14, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC), a global diversified pharmaceutical company enriching lives through a relentless drive to deliver better health outcomes, recently presented at two global healthcare conferences. Bausch Health’s gastroenterology (GI) business, Salix Pharmaceuticals presented data from its Amiselimod clinical trials at Digestive Disease Week (DDW) 2024 during the IMIBD Late Breakers and Innovations in IBD session on May 19, 2024, in Washington, D.C., and post hoc pooled data analysis of Rifaximin at the International Liver Congress 2024™ (ILC 2024): Annual Meeting of the European Association for the Study of the Liver (EASL) on June 8, 2024 in Milan, Italy. Amiselimod at DDW Bausch Health shared positive late-breaking data from a global Phase 2 study evaluating Amiselimod for the treatment of patients with active, mild to moderate ulcerative colitis (UC) at Digestive Disease Week® (DDW) 2024. The data were presented by Dr. Steven Hanauer and Clifford Joseph Barborka, Professor of Medicine at Northwestern University. The randomized, double-blind, placebocontrolled trial investigated the efficacy and safety of Amiselimod over a 12-week treatment period. The results demonstrated that Amiselimod was well-tolerated and showed promise as a potential treatment for inducing remission in UC patients. Specifically: In the primary endpoint measure – both doses of Amiselimod (0.2mg and 0.4mg daily) led to a significantly greater improvement in Modified Mayo Score (MMS) compared to a placebo group on Day 85. This score reflects disease activity, with a lower score indicating better outcomes. Patients taking Amiselimod experienced an average improvement of -2.3 points, compared to - 1.6 points in the placebo group (p-score <0.01) In the secondary measures, endoscopic improvement and clinical remission, after 12 weeks, a significantly higher proportion of patients receiving Amiselimod achieved endoscopic improvement (over 42%) compared to placebo (23%) with statistically significant difference (pscore <0.01). Similarly, over 31% of patients on Amiselimod experienced clinical remission compared to 18% in the placebo group (p-score = 0.03). In the safety evaluation patients were closely monitored for any adverse events throughout the 12 weeks. The findings concluded that Amiselimod treatment was well-tolerated. “Our recent trial results are a testament to the dedication and expertise of our research teams,” said Dr. Tage Ramakrishna, Chief Medical Officer, President, R&D. “The promising data from this Amiselimod trial brings us closer to offering new, effective treatment to patients suffering from ulcerative colitis (UC). We are excited to advance this therapy to the next stage of development.” Ulcerative colitis is a chronic disease affecting the large intestine, or colon. The condition causes inflammation and ulceration (sores) along the lining of the colon, which can lead to abdominal pain, cramps, bleeding and diarrhea.1 In ulcerative colitis, the inflammation starts at the rectum and continues through the colon. Symptoms include diarrhea with blood and mucus, pain on the left-hand side of the abdomen, urgency and tenesmus (the feeling of needing to pass stools even if the bowel is empty).1 Rifaximin at EASL At the European Association for the Study of the Liver (EASL) Conference, Bausch Health presented data comparing Rifaximin monotherapy to lactulose monotherapy in preventing overt hepatic encephalopathy (OHE) recurrence in cirrhosis patients with a history of OHE. This analysis, based on pooled data from two randomized trials (one phase 3 double-blind and one phase 4 open-label), focused on adult patients with cirrhosis and a history of OHE episodes showed that: Significantly fewer patients treated with Rifaximin monotherapy experienced an OHE episode compared with lactulose monotherapy (23.2% vs 49.0%, respectively; P<0.0001). Rifaximin monotherapy reduced the risk of a breakthrough OHE event by 60% versus lactulose monotherapy during 6 months of treatment. Rifaximin monotherapy was well tolerated. These data suggest Rifaximin monotherapy has the potential to be a viable treatment option for OHE recurrence risk reduction in appropriate patient populations. About Amiselimod Amiselimod is a sphingosine-1-phosphate (S1P) receptor functional antagonist and, by inhibiting the receptor function of the lymphocyte sphingosine-1-phosphate (S1P) receptor, retains lymphocytes sequestered in the lymph nodes and prevents them from contributing to autoimmune reactions.1 Due to this mechanism of action, Amiselimod may potentially be useful for various autoimmune diseases.2 Affinity to S1P1 and S1P5 receptor subtypes, suggests that Amiselimod could potentially have a more pronounced effect on ulcerative colitis related inflammation than compounds with restricted activity on S1P1 receptor subtype exclusively or combined activity on S1P1 and S1P5.2 About XIFAXAN XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. About Salix Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and provide health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn. References 1 IBD Clinic, University of Alberta: http://www.ibdclinic.ca/what-is-ibd/ulcerative-colitis/ 2 BiseraStepanovska, AndreaHuwiler. Targeting the S1P receptor signaling pathways as a promising approach for treatment of autoimmune and inflammatory diseases. Pharmacological Research. February 2019. The XIFAXAN 550 mg product and the XIFAXAN trademark are licensed by Alfasigma S.p.A to Salix Pharmaceuticals or its affiliates. ©2024 Salix Pharmaceuticals or its affiliates. UNB.0018.USA.24 << Back to News Releases

临床结果临床2期临床3期

2024-05-17

·BioSpace

Salix to Present Late-Breaking Data from Phase 2 Trial of Amiselimod in Active Ulcerative Colitis at Digestive Disease Week 2024

LAVAL, QC / ACCESSWIRE / May 17, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals, Ltd., today announced that they will be presenting data from its Phase 2 trial evaluating Amiselimod as treatment for active ulcerative colitis (UC). The data will be presented at Digestive Disease Week (DDW) 2024 during the IMIBD Late Breakers and Innovations in IBD session on Sunday, May 19, 2024, in Washington, D.C. "We are pleased to present late-breaking data on Amiselimod, our investigational, oral, sphingosine 1-phosphate (S1P) receptor modulator as a potential treatment for the induction of remission in UC," said Tage Ramakrishna, M.D., Chief Medical Officer and President of Research & Development, Bausch Health. "The abstract underscores our steadfast commitment to developing new and innovative therapies for patients with UC." The research to be featured at DDW 2024 and available via the meeting's online platform is as follows: Hanauer, Stephen B. et al. "Amiselimod for the treatment of active ulcerative colitis: a randomized, double-blind, placebo-controlled trial" Abstract #4094796 The Phase 2 clinical trial was a 12-week, double-blind, placebo-controlled, randomized, dose ranging study to evaluate the efficacy and safety of Amiselimod in 320 patients with mildly-to- moderately active UC. Bausch Health announced positive topline results from this study in December 2023. About Amiselimod Amiselimod is a sphingosine-1-phosphate (S1P) receptor functional antagonist and, by inhibiting the receptor function of the lymphocyte sphingosine-1-phosphate (S1P) receptor, retains lymphocytes sequestered in the lymph nodes and prevents them from contributing to autoimmune reactions.1 Due to this mechanism of action, Amiselimod may potentially be useful for various autoimmune diseases.2 Affinity to S1P1 and S1P5 receptor subtypes, suggests that Amiselimod could potentially have a more pronounced effect on ulcerative colitis related inflammation than compounds with restricted activity on S1P1 receptor subtype exclusively or combined activity on S1P1 and S1P5. 3 About Salix Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and provide health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit and connect with us on Twitter and LinkedIn. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals, and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit and connect with us on Twitter and LinkedIn. About DDW Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 18-21, 2024. The meeting showcases more than 4,400 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at References 1. Kunio Sugahara, Yasuhiro Maeda. Amiselimod, a novel sphingosine 1‐phosphate receptor‐1 modulator, has potent therapeutic efficacy for autoimmune diseases, with low bradycardia risk. British Journal of Pharmacology. January 2017. 2. Peyrin-Biroulet, Ronald Christopher Modulation of sphingosine-1-phosphate in inflammatory bowel disease. Autoimmunity Reviews. February 2017. 3. BiseraStepanovska, AndreaHuwiler. Targeting the S1P receptor signaling pathways as a promising approach for treatment of autoimmune and inflammatory diseases. Pharmacological Research. February 2019. Investor Contact: Media Contact: Garen Sarafian Kevin Wiggins ir@bauschhealth.com corporate.communications@bauschhealth.com (877) 281-6642 (toll-free) (908) 541-3785 SOURCE: Salix Pharmaceuticals View the original press release on accesswire.com

临床2期临床结果

100 项与 Amiselimod hydrochloride 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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适应症	最高研发状态	国家/地区	公司	日期
溃疡性结肠炎	临床2期	美国	Bausch Health Americas, Inc.	2021-09-29
克罗恩病	临床2期	日本	Mitsubishi Tanabe Pharma Corp.	2015-03-01
克罗恩病	临床2期	捷克	Mitsubishi Tanabe Pharma Corp.	2015-03-01
克罗恩病	临床2期	法国	Mitsubishi Tanabe Pharma Corp.	2015-03-01
克罗恩病	临床2期	德国	Mitsubishi Tanabe Pharma Corp.	2015-03-01
克罗恩病	临床2期	匈牙利	Mitsubishi Tanabe Pharma Corp.	2015-03-01
克罗恩病	临床2期	以色列	Mitsubishi Tanabe Pharma Corp.	2015-03-01
克罗恩病	临床2期	意大利	Mitsubishi Tanabe Pharma Corp.	2015-03-01
克罗恩病	临床2期	荷兰	Mitsubishi Tanabe Pharma Corp.	2015-03-01
克罗恩病	临床2期	波兰	Mitsubishi Tanabe Pharma Corp.	2015-03-01

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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


Corporate Publications 人工标引	临床2期	溃疡性结肠炎	-	Amiselimod 0.2 mg/d	艱齋遞構構齋鏇繭醖鬱(淵繭構艱蓋鹹糧鬱築鏇) = 鬱艱膚鑰範簾願廠夢選範憲選簾積網襯願範遞 (簾鹹簾憲觸構簾範襯夢 ) 更多	积极	2024-06-14
				Amiselimod 0.4 mg/d	艱齋遞構構齋鏇繭醖鬱(淵繭構艱蓋鹹糧鬱築鏇) = 獵鹽齋壓顧膚襯製繭窪範憲選簾積網襯願範遞 (簾鹹簾憲觸構簾範襯夢 ) 更多
NCT04857112 (Corporate Publications) 人工标引	临床2期	溃疡性结肠炎	320	Amiselimod	願獵餘簾鬱觸網鹹壓繭(構夢鑰夢窪憲觸構鏇積) = 範鬱網鏇齋膚壓艱廠積鹹製鹽蓋壓獵壓簾襯遞 (遞艱獵鑰餘夢獵鏇積淵 ) 达到更多	积极	2023-12-21
				Placebo	願獵餘簾鬱觸網鹹壓繭(構夢鑰夢窪憲觸構鏇積) = 選淵製鹽鹹鏇網齋蓋繭鹹製鹽蓋壓獵壓簾襯遞 (遞艱獵鑰餘夢獵鏇積淵 ) 达到更多
NCT01890655 (Pubmed) 人工标引	临床2期	复发性多发性硬化	415	amiselimod	餘鏇憲範壓遞築鏇夢膚(淵鹽醖廠廠艱窪繭憲鹽) = 鹽網鏇顧淵觸鑰夢觸範網築網窪觸觸膚艱獵鬱 (艱醖繭築遞憲憲範製範 ) 更多	积极	2018-10-01