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Bausch Health
Reports Promising R&D Trial Updates on
Amiselimod
and Scientific Data Presented at International Healthcare Conferences
2024-06-14
·
BioSpace
临床结果
临床2期
临床3期
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
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文中所述内容并不反映新药情报库及其所属公司任何意见及观点,如有版权侵扰或错误之处,请及时联系我们,我们会在24小时内配合处理。
机构
Bausch Health Cos., Inc.
Salix Pharmaceuticals Ltd.
Northwestern University
[+1]
适应症
炎症性肠病
溃疡性结肠炎
消化系统疾病
[+15]
靶点
S1PR1
S1PR5
药物
Amiselimod hydrochloride
利福昔明
乳果糖
标准版
¥
16800
元/账号/年
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