Bausch Health Updates on Amiselimod and Presents Data at Conferences

Bausch Health Companies Inc., a globally diversified pharmaceutical company, has recently participated in two significant healthcare conferences, presenting data from its gastroenterology business, Salix Pharmaceuticals. The company highlighted findings from Amiselimod clinical trials at Digestive Disease Week (DDW) 2024 and shared results from a post hoc pooled data analysis of Rifaximin at the International Liver Congress 2024 (ILC 2024) in Milan, Italy.

At DDW 2024, held on May 19 in Washington, D.C., Bausch Health delivered promising data from a Phase 2 study evaluating Amiselimod for treating active, mild to moderate ulcerative colitis (UC). This study, presented by Dr. Steven Hanauer and Clifford Joseph Barborka from Northwestern University, was a randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of Amiselimod over 12 weeks.

The study's primary endpoint measured improvement in the Modified Mayo Score (MMS), which indicates disease activity in UC. Both doses of Amiselimod (0.2mg and 0.4mg daily) showed significantly greater improvements in MMS compared to placebo by Day 85, with patients on Amiselimod improving by an average of -2.3 points versus -1.6 points in the placebo group.

Secondary measures included endoscopic improvement and clinical remission. Over 42% of patients receiving Amiselimod achieved endoscopic improvement compared to 23% in the placebo group. Clinical remission was seen in over 31% of Amiselimod patients versus 18% in the placebo group. The treatment was well-tolerated, with no significant safety concerns during the 12-week period.

Dr. Tage Ramakrishna, Chief Medical Officer, President of R&D at Bausch Health, expressed optimism about these findings, stating that the data brings the company closer to offering effective treatments for UC patients.

Ulcerative colitis is a chronic condition causing inflammation and ulceration in the colon, leading to symptoms such as abdominal pain, diarrhea with blood and mucus, and an urgent need to pass stools. The condition starts at the rectum and can affect the entire colon.

At the European Association for the Study of the Liver (EASL) Conference on June 8, 2024, Bausch Health presented data on Rifaximin, comparing its effectiveness to lactulose in preventing recurrence of overt hepatic encephalopathy (OHE) in cirrhosis patients. This post hoc analysis included data from two randomized trials, focusing on patients with a history of OHE.

The analysis revealed that significantly fewer patients treated with Rifaximin monotherapy experienced OHE episodes compared to those treated with lactulose (23.2% vs. 49.0%). Rifaximin reduced the risk of breakthrough OHE events by 60% over a six-month treatment period and was well tolerated, indicating its potential as a viable treatment option for reducing OHE recurrence in appropriate patients.

Amiselimod, a sphingosine-1-phosphate (S1P) receptor functional antagonist, retains lymphocytes in lymph nodes, preventing them from contributing to autoimmune reactions. This mechanism suggests that Amiselimod could be effective in treating various autoimmune diseases, including UC, due to its affinity to S1P1 and S1P5 receptor subtypes.

Rifaximin, marketed under the brand name XIFAXAN, is indicated for reducing the risk of overt hepatic encephalopathy recurrence and treating irritable bowel syndrome with diarrhea in adults.

Salix Pharmaceuticals, a subsidiary of Bausch Health, is dedicated to developing and marketing innovative products for gastrointestinal diseases. With over 30 years of experience, Salix continues to improve patient lives and provide healthcare providers with effective solutions for chronic conditions. Salix operates primarily in the U.S., focusing on gastroenterology, hepatology, pain specialists, and primary care.

Bausch Health Companies Inc. strives to deliver better health outcomes through its extensive product portfolio, including gastroenterology, hepatology, neurology, dermatology, medical aesthetics, international pharmaceuticals, and eye health. The company aims to be a globally integrated healthcare provider, trusted by patients, healthcare professionals, employees, and investors.