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

Rhea-AI Summary

Bausch Health Companies (NYSE:BHC)(TSX:BHC) and its gastroenterology unit, Salix Pharmaceuticals, will present late-breaking data from a Phase 2 trial of Amiselimod for active ulcerative colitis (UC) at Digestive Disease Week 2024. The presentation, scheduled for May 19, 2024, in Washington D.C., will highlight Amiselimod's potential as an oral treatment for UC remission. The 12-week, double-blind, placebo-controlled study involved 320 patients and showed positive topline results, as announced in December 2023. The abstract, titled "Amiselimod for the treatment of active ulcerative colitis," authored by Stephen B. Hanauer et al., emphasizes Bausch's commitment to innovative UC therapies.

Positive

• Bausch Health is presenting late-breaking data from a successful Phase 2 trial of Amiselimod at a major conference.
• The trial showed positive topline results, indicating potential efficacy for UC treatment.
• The study involved a sizable sample of 320 patients, adding robustness to the findings.
• Bausch Health is actively pursuing innovative treatments, which may drive future growth.

Negative

• The data presented is still from a Phase 2 trial, requiring further validation in Phase 3 before market approval.
• No specific details on the efficacy metrics or safety profile of Amiselimod were shared in the press release.
• Investors may face a prolonged timeline before potential revenue from Amiselimod materializes.

LAVAL, QC / ACCESSWIRE / May 17, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals, 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 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 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 www.ddw.org.

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

FAQ

What is Bausch Health Companies presenting at Digestive Disease Week 2024?

Bausch Health Companies is presenting late-breaking data from a Phase 2 trial of Amiselimod for active ulcerative colitis.

When and where will Bausch Health present the Amiselimod data?

The data will be presented on May 19, 2024, at Digestive Disease Week in Washington D.C.

What is the focus of the Phase 2 trial for Amiselimod?

The Phase 2 trial focused on evaluating the efficacy and safety of Amiselimod in treating mildly-to-moderately active ulcerative colitis.

What were the results of the Phase 2 trial for Amiselimod?

The trial showed positive topline results, indicating potential efficacy for UC treatment.

How many patients participated in the Phase 2 trial of Amiselimod?

The trial included 320 patients with mildly-to-moderately active ulcerative colitis.