Bausch Health Announces Positive Topline Results From Global Phase 2 Study Evaluating Amiselimod to Treat Ulcerative Colitis

Trial Meets Both Primary and Key Secondary Endpoints

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health" or the "Company") today announced positive topline results from the Company's Phase 2 study evaluating Amiselimod, an investigative S1P antagonist, for the treatment of ulcerative colitis (UC

"We are thrilled with these impressive topline results, and believe that this could offer a much needed improvement in therapy available for patients with ulcerative colitis," said Thomas J. Appio, Chief Executive Officer, Bausch Health.

Amiselimod met the primary and key secondary endpoints including clinical and endoscopic measures in the double-blind period of the study; the open-label extension up to 52 weeks is currently ongoing. Efficacy results were similar for both dose groups (0.2 mg QD and 0.4 mg QD).

The topline results for the key endpoints were as follows:

  • The primary endpoint, mean change in modified Mayo Score at Day 85 (-2.3) versus placebo (-1.6), (p = 0.002).
  • 32.4% of patients on Amiselimod achieved clinical remission, compared to 17.8% on placebo, (p=0.007)
  • 42.7% of patients on Amiselimod achieved endoscopic improvement (Mayo endoscopy subscore of ≤ 1), compared to 23.4% on placebo, (p

Amiselimod was well-tolerated, with no unexpected adverse events; coupled with the previous thorough QT study, this indicates that Amiselimod has a favorable safety profile. The full data set from this trial will be available early next year.

Bausch Health's 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.

"Our R&D team will be presenting detailed results at upcoming medical conferences, and we plan to meet with regulatory agencies to advance the program into Phase 3," said Dr. Tage Ramakrishna, Chief Medical Officer, President, R&D, Bausch Health.

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, S1P4 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 Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter (X) and LinkedIn.

Forward-looking Statements
This news release contains forward-looking information and statements, within the meaning of applicable securities laws (collectively, "forward-looking statements"), including, but not limited to, statements relating to the Company's ongoing research and development efforts. Forward-looking statements may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions, and phrases or statements that certain actions, events or results may, could, should or will be achieved, received or taken, or will occur or result, and similar such expressions also identify forward-looking information. These forward-looking statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Company's most recent annual and quarterly reports and detailed from time to time in the Company's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which risks and uncertainties are incorporated herein by reference. Additional information regarding certain of these material factors and assumptions may be found in the Company's filings described above. The Company believes that the material factors and assumptions reflected in these forward-looking statements are reasonable in the circumstances, but readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

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.

###

Media Contact:

Kevin Wiggins
corporate.communications@bauschhealth.com
(908) 541-3785

Investor Contact:

Lisa Wilson
ir@bauschhealth.com
(877) 281-6642 (toll free)

SOURCE: Bausch Health Companies Inc.



View the original press release on accesswire.com

News Provided by ACCESSWIRE via QuoteMedia

BHC:CA,BHC
The Conversation (0)

Medtronic receives FDA approval for Inceptiv closed-loop spinal cord stimulator

Closed-loop sensing capability instantly and automatically adjusts therapy while treating chronic pain

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain. Inceptiv is the first Medtronic SCS device to offer a closed-loop feature that senses biological signals along the spinal cord and automatically adjusts stimulation in real time, keeping therapy in harmony with the motions of daily life.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
Illustration of heart attack.

Investing in Cardiovascular MedTech Companies

Cardiovascular diseases remain the leading global cause of death, taking an estimated 17.9 million lives annually, based on data from the World Health Organisation. Over 80 percent of these deaths are due to heart attacks and strokes, while one-third of them occur in people under seventy years of age.

Efforts to address the core risk factors associated with cardiovascular diseases are coinciding with recent innovations in medical technology, which have been critical in not only preventing and managing them but also increasing the survival rate.

As medical technologies associated with the diagnosis and treatment of cardiovascular disease continue to evolve, medical technology companies provide an opportunity for investors to create wealth through health.

Keep reading...Show less

Thermo Fisher Scientific Reports First Quarter 2024 Results

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the first quarter ended March 30, 2024.

First Quarter 2024 Highlights

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
March Quarterly Appendix 4C

March Quarterly Appendix 4C

Cardiex Limited (ASX:CDX) (Cardiex, the Company) has released its Quarterly Cash Flow Report.


Keep reading...Show less
Cardiex March 2024 Quarter Update

Cardiex March 2024 Quarter Update

Cardiex Limited (ASX:CDX) (Cardiex, the Company) is pleased to present its Quarterly Report.
Keep reading...Show less

Latest Press Releases

Related News

×