Rifaximin

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

BOSTON, June 4, 2024 /PRNewswire/ -- Researchers from Analysis Group, a global leader in health economics and outcomes research (HEOR), have coauthored a study detailing how treatment-free intervals (TFIs) can be an effective surrogate in retrospective data analyses for understanding therapy effectiveness for conditions that present multifaceted symptoms across widely divergent patient populations, such as irritable bowel syndrome with diarrhea (IBS-D). The study, published in the journal Advances in Therapy, is the first to use TFIs to assess real-world IBS-D therapy response, using two of the most commonly prescribed treatments in the US: rifaximin and eluxadoline. While the Food and Drug Administration (FDA) recommends using a five-item opinion-based questionnaire to measure patient-reported outcomes (PROs) that capture clinically important signs and symptoms to define treatment effects in clinical trials, it is challenging to apply this method to evaluate real-world outcomes in retrospective studies. The difficulty lies in the complex presentation of IBS-D, a common, chronic, relapsing, and potentially severe disorder of gut–brain interaction characterized by troublesome symptoms such as abdominal pain, diarrhea, fecal urgency, and bloating. To overcome these challenges, study investigators analyzed US commercial claims data for 9,255 IBS-D patients receiving one of the two treatments over the course of one year. The researchers focused on patients' TFI patterns – the length of time a patient remains off treatment after a course of therapy. Patient characteristics included age, sex, health plan type, region, and provider specialty, as of the index date. During baseline, medically relevant comorbidities (both gastrointestinal- and mental health–related), procedures (e.g., anesthesia, surgery, radiation services), and treatments were reported. Investigators specifically examined the duration of the index treatment, the number of prescription fills, and all-cause health care costs among adult patients with IBS-D treated with rifaximin or eluxadoline. The researchers concluded that TFIs may be a meaningful proxy for measuring treatment effectiveness in IBS-D. Using this method, they also found that patients treated with rifaximin had longer TFIs and lower health care costs than patients treated with eluxadoline. "The challenges of studying IBS-D are similar in many ways to those faced with oncology, where important treatment goals include medication-free periods associated with symptom control, especially when there is a treatment-related toxicity or financial burden associated with treatment changes or combination therapy," said study investigator Annie Guérin, a Managing Principal with Analysis Group. "Our approach to using TFIs was based on the proven strategies used in oncology, where patients value treatment-free periods because they are associated with improved health-related quality of life." The study, "Treatment-Free Interval: A Novel Approach to Assessing Real-World Treatment Effectiveness and Economic Impact Among Patients with Irritable Bowel Syndrome with Diarrhea," was published in April in Advances in Therapy. In addition to Ms. Guérin, investigators included Vice President Patrick S. Gagnon, Associate Rebecca Bungay, and Senior Research Professional Remi Bellefleur of Analysis Group; Brian E. Lacy of Mayo Clinic; Zeev Heimanson of Salix Pharmaceuticals; Brock Bumpass, Danellys Borroto, and Ankur A. Dashputre of Bausch Health; and George Joseph of BioNTech US. Funding was provided by Bausch Health. To learn more about Analysis Group's HEOR capabilities, visit About Analysis Group's HEOR, Epidemiology & Market Access Practice Founded in 1981, Analysis Group is one of the largest international economics consulting firms, with more than 1,200 professionals across 14 offices. Analysis Group's health care experts apply analytical expertise to health economics and outcomes research (HEOR), clinical research, market access and commercial strategy, and health care policy engagements, as well as drug safety-related engagements in epidemiology. Analysis Group's internal experts, together with our network of affiliated experts from academia, industry, and government, provide our clients with exceptional breadth and depth of expertise and end-to-end consulting services globally. Contact: Analysis Group Eric Seymour, +1 978 273 6049 [email protected] SOURCE Analysis Group