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.

Start Date29 Sep 2021

Sponsor / Collaborator

Bausch Health Americas, Inc.

NCT02389790

/ CompletedPhase 2

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）

Start Date01 Aug 2015

Sponsor / Collaborator

Tanabe Pharma Corp.

NCT02378688

/ CompletedPhase 2

A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease

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

Start Date01 Mar 2015

Sponsor / Collaborator

Tanabe Pharma Corp.

100 Clinical Results associated with Amiselimod hydrochloride

100 Translational Medicine associated with Amiselimod hydrochloride

100 Patents (Medical) associated with Amiselimod hydrochloride

Literatures (Medical) associated with Amiselimod hydrochloride

10 Jan 2025·ACS Infectious Diseases

High-Throughput Screening of More Than 30,000 Compounds for Anthelmintics against Gastrointestinal Nematode Parasites

Article

Author: Thompson, Paul R. ; Chen, Paulina ; Barasa, Leonard ; Aroian, Raffi V. ; Kim, Youmie ; Elfawal, Mostafa A. ; Goetz, Emily ; Savinov, Sergey N.

Gastrointestinal nematodes (GINs) are among the most common parasites of humans, livestock, and companion animals. GIN parasites infect 1-2 billion people worldwide, significantly impacting hundreds of millions of children, pregnant women, and adult workers, thereby perpetuating poverty. Two benzimidazoles with suboptimal efficacy are currently used to treat GINs in humans as part of mass drug administrations, with many instances of lower-than-expected or poor efficacy and possible resistance. Thus, new anthelmintics are urgently needed. However, screening methods for new anthelmintics using human GINs typically have low throughput. Here, using our novel screening pipeline that starts with human hookworms, we screened 30,238 unique small molecules from a wide range of compound libraries, including ones with generic diversity, repurposed drugs, natural derivatives, known mechanisms of action, as well as multiple target-focused libraries (e.g., targeting kinases, GPCRs, and neuronal proteins). We identified 55 compounds with broad-spectrum activity against adult stages of two evolutionary divergent GINs, hookworms (Ancylostoma ceylanicum) and whipworms (Trichuris muris). Based on known databases, the targets of these 55 compounds were predicted in nematode parasites. One novel scaffold from the diversity set library, F0317-0202, showed good activity (high motility inhibition) against both GINs. To better understand this novel scaffold's structure-activity relationships (SAR), we screened 28 analogs and created SAR models highlighting chemical and functional groups required for broad-spectrum activity. These studies validate our new and efficient screening pipeline at the level of tens of thousands of compounds and provide an important set of new GIN-active compounds for developing novel and broadly active anthelmintics.

01 Jan 2025·AMERICAN JOURNAL OF OPHTHALMOLOGY

Silk-Derived Protein-4 Versus Vehicle Control in Treating Patients With Moderate to Severe Dry Eye Disease: A Randomized Clinical Trial

Article

Author: Lawrence, Brian D. ; Levy, Brian ; Lawrence, Brian D ; Infanger, David W. ; Infanger, David W ; Karpecki, Paul M. ; Karpecki, Paul M

PURPOSE:

In this study the safety and efficacy of silk-derived protein 4 (SDP-4), also known as amlisimod, eye drops against a vehicle control formulation in patients with moderate to severe dry eye disease (DED) was assessed. SDP-4 is a novel, naturally derived, anti-inflammatory wetting agent that enhances coating on the ocular surface.

DESIGN:

Exploratory Phase 2, 12- and 8-week, serial cohort, multicenter, double-masked, randomized, vehicle-controlled study.

METHODS:

In the first cohort (N = 305), patients were randomized 1:1:1:1 to SDP-4 (0.1%, 1%, 3% wt./wt.) or vehicle control and dosed 2 times per day (BID), while in the second cohort patients were randomized 1:1 with 1% wt./wt. SDP-4, the best performing formulation from the first cohort, or vehicle control BID (N = 151). Diagnosed DED patients were treated in the United States between April 2019 and May 2021. The first cohort of subjects had moderate to severe baseline symptoms, while the second cohort had moderate baseline symptoms to study the impact of baseline symptoms on SDP-4 performance. Key sign and symptom end points were mean change from baseline in TBUT and total SANDE score (0-100 visual analog scale) throughout the study.

RESULTS:

SDP-4 (1%) significantly increased TBUT vs the vehicle control (P < .05) at days 28 and 56 in the first cohort, and patient symptomatology from baseline was reduced by 46% based on subject reported SANDE VAS scores at day 84. Patients with more severe baseline DED symptoms experienced a significantly greater amount of relief than when compared to patients with moderate DED (P < .05). All treatment groups were well tolerated with a 2.6% total discontinuation rate.

CONCLUSIONS:

To the best of our knowledge, this was the first-in-human use of SDP-4 in a clinical trial. SDP-4 is a first-in-class protein ingredient that offers a safe and multi-modal treatment approach for alleviating severe DED symptoms within a novel formulation.

01 Dec 2024·CURRENT TOPICS IN MEDICINAL CHEMISTRY

The Current Landscape in the Development of Small-molecule Modulators Targeting Sphingosine-1-phosphate Receptors to Treat Neurodegenerative Diseases

Review

Author: Sahu, Sujit Kumar ; Kar, Sidhartha Sankar ; Gharai, Soumya Ranjan ; Swain, Sharada Prasanna ; Ravichandiran, Velayutham

Sphingosine 1-phosphate (S1P) is extensively researched as a lysophospholipid and is crucial in various physiological and pathological processes. It achieves this via signalling through five different subtypes of G protein-coupled receptors (GPCRs), namely S1PR1 to S1PR5. S1PR modulators possess the ability to traverse the blood-brain barrier, potentially leading to direct actions within the Central Nervous System (CNS). S1PR modulators specifically bind to receptors located on the surface of naive and central memory lymphocytes, causing these cells to be trapped or confined within the lymph node. The investigation of the S1P pathway has resulted in the approval of three S1PR modulators, namely fingolimod, siponimod, and ozanimod, as medications for the treatment of patients suffering from Multiple Sclerosis (MS). Additionally, new S1PR modulators, such as ponesimod and etrasimod, are currently being developed and tested in clinical trials. Research on the creation of S1P modulators in neurodegenerative illnesses is ongoing as scientists continue to explore novel possibilities for selective S1P modulators. This study provides a concise overview of sphingolipid metabolism, the mechanism by which S1P receptors are affected, and the structural characteristics of several small molecule S1P modulators, with a particular focus on their structure-activity connections.

News (Medical) associated with Amiselimod hydrochloride

14 Jun 2024

·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

Clinical ResultPhase 2Phase 3

14 Jun 2024

·www.biospace.com

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

Clinical ResultPhase 2Phase 3

17 May 2024

·www.biospace.com

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

Phase 2Clinical Result

100 Deals associated with Amiselimod hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D10905	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	Phase 2	United States	Bausch Health Americas, Inc.	29 Sep 2021
Colitis, Ulcerative	Phase 2	Japan	Bausch Health Americas, Inc.	29 Sep 2021
Colitis, Ulcerative	Phase 2	Australia	Bausch Health Americas, Inc.	29 Sep 2021
Colitis, Ulcerative	Phase 2	Belarus	Bausch Health Americas, Inc.	29 Sep 2021
Colitis, Ulcerative	Phase 2	Bulgaria	Bausch Health Americas, Inc.	29 Sep 2021
Colitis, Ulcerative	Phase 2	Czechia	Bausch Health Americas, Inc.	29 Sep 2021
Colitis, Ulcerative	Phase 2	Estonia	Bausch Health Americas, Inc.	29 Sep 2021
Colitis, Ulcerative	Phase 2	Germany	Bausch Health Americas, Inc.	29 Sep 2021
Colitis, Ulcerative	Phase 2	Hungary	Bausch Health Americas, Inc.	29 Sep 2021
Colitis, Ulcerative	Phase 2	Italy	Bausch Health Americas, Inc.	29 Sep 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Corporate Publications Manual	Phase 2	Colitis, Ulcerative	-	Amiselimod 0.2 mg/d	shcwjbujqd(owyjudixvp) = hgrvmdlhrx mfzuqslory (lanlnscpex ) View more	Positive	14 Jun 2024
				Amiselimod 0.4 mg/d	shcwjbujqd(owyjudixvp) = xeixuilmgu mfzuqslory (lanlnscpex ) View more
NCT04857112 (Corporate Publications) Manual	Phase 2	Colitis, Ulcerative	320	Amiselimod	zfpmviexox(czlginkihc) = mzvpdgghgc lvzcolidpr (sofpjmkipa ) Met View more	Positive	21 Dec 2023
				Placebo	zfpmviexox(czlginkihc) = yyryxsasna lvzcolidpr (sofpjmkipa ) Met View more
NCT02293967 (Pubmed \| Xenobiotica)	Phase 1	-	8	MT-1303	kdhyexlofz(etmzrzgynj) = wfxqsovltc lkiroinglz (ncgbepgqco ) View more	-	01 Sep 2019
ECCO2019	Phase 2	Perianal fistula due to Crohn's disease	78	Amiselimod 0.4 mg	ybqsmybdci(wornzueemk) = hslpadbztj ljbbskgpzz (wylztiolmn ) View more	Negative	06 Mar 2019
				Placebo	ybqsmybdci(wornzueemk) = aacaftahsi ljbbskgpzz (wylztiolmn ) View more
NCT01890655 (Pubmed) Manual	Phase 2	Multiple sclerosis relapse	415	amiselimod	mibqdcurtn(qmrawdbmxz) = weaoaxfvvl nxrkglycum (oltaxpucjz ) View more	Positive	01 Oct 2018

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