Proctocolitis

LAVAL, QC / ACCESSWIRE / April 3, 2024 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), today announced the first public drug plan listings for PrUCERIS® (budesonide) aerosol foam to treat mild to moderate distal ulcerative colitis in adults.1 UCERIS is now available for patients through the public drug plans of five Canadian provinces: Ontario, Quebec, Saskatchewan, New Brunswick and Nova Scotia. These first public drug plan listings for UCERIS come following the signing of a letter of intent with the pan-Canadian Pharmaceutical Alliance (pCPA) early this year, setting out the parameters for listing of the treatment by the public drug plans of the provinces, territories and federal government. "Bausch Health is very pleased that patients with distal ulcerative colitis in five provinces, including the two largest, will now have access to UCERIS and we look forward to the rapid completion of listing agreements with other public drug plans so more Canadians will have insured access to this new therapy," said Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health. "We want to provide additional effective treatment options to Canadians." UCERIS, part of the Company's growing gastrointestinal franchise, has been available in Canada by prescription since September 2023 and is covered by the majority of private insurance drug plans in Canada. "Living with ulcerative colitis means experiencing painful, frequent bowel movements, which can also be bloody. Effective treatments for this chronic inflammatory bowel disease are vital to have any quality of life," said Gail Attara, President and Chief Executive Officer of the Gastrointestinal Society, a patient group known by its badgut.org website. "We are pleased that public drug plans in Canada are starting to make the new ulcerative colitis treatment UCERIS available as a covered benefit and look forward to their example being followed by all drug insurance plans across Canada." UCERIS is the only glucocorticosteroid rectal foam available in Canada indicated for the induction of remission in adult patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.1 In a study comparing budesonide foam and budesonide enema in patients with active distal ulcerative colitis, most patients (84%) preferred the foam formulation because of its better tolerability and easier application.2 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.3 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).3 In the two clinical studies on which the approval of UCERIS rectal aerosol foam was based, a significantly higher proportion of patients in the UCERIS group than in the placebo group were in remission at Week 6 (38.3% and 44.0% vs. 25.8% and 22.4% respectively, pooled p<0.0001) and had a rectal bleeding sub-score of 0 at Week 6 (46.6% and 50.0% vs. 28.0% and 28.6% respectively, pooled p<0.0001). There was also a higher proportion of patients in the UCERIS group than in the placebo group with an endoscopy sub-score of 0 or 1 at Week 6 (55.6% and 56.0% vs. 43.2% and 36.7% respectively.1 About Bausch Health Bausch Health Companies Inc. (NYSE/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, healthcare professionals, employees and investors. For more information, visit and connect with us on Twitter and LinkedIn. The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at . REFERENCES 1 Bausch Health, Canada Inc., UCERIS rectal foam Product Monograph, 2 Gross V, et al, Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis, Aliment Pharmacol Ther. 2006;23(2):303-312. 3 IBD Clinic, University of Alberta: Investor Contact: Media Contact: Kevin Wiggins ir@bauschhealth.com corporate.communications@bauschhealth.com (877) 281-6642 (toll free) (908) 927-1198 SOURCE: Bausch Health Companies Inc. View the original press release on accesswire.com

HEFEI, China, Feb. 20, 2024 /PRNewswire/ -- Kangpu Biopharmaceuticals, a clinical-stage company dedicated to the discovery and development of novel therapeutics for the treatment of cancer, autoimmune diseases, and inflammation, through targeted protein degradation technology, today announced that a poster on preclinical efficacy data of KPG-818 in Crohn's disease will be presented at the upcoming 19th Congress of European Crohn's and Colitis Organisation (ECCO), taking place in Stockholm, Sweden, February 21-24, 2024. Poster Title: Therapeutic Effects of KPG-818 in a Trinitrobenzene Sulfonic Acid-Induced Mouse Crohn's/Ulcerative Colitis Model Abstract Number: EC24-0844 Exhibition Zone: Poster Exhibition, Hall A Presentation Number: P131 Crohn's disease is a chronic and difficult-to-treat autoimmune disorder. The current available therapeutic options for this condition are very limited, and there remain significant unmet medical needs. In preclinical studies, KPG-818 demonstrated potent therapeutic efficacy in mouse model of Crohn's disease. KPG-818 significantly improved clinical symptoms, colorectitis, ulcers, and local immune cell infiltration in the model animals. Based on the recent Pre-IND meeting with the FDA, Kangpu Biopharmaceuticals will submit IND application for Phase II clinical trials of KPG-818 for Crohn's disease in the United States. About KPG-818 KPG-818 is a novel generation of small molecule modulators of CRBN E3 ubiquitin ligase complex CRL4-CRBN. It provides potent degradation of Aiolos (IKZF3) and Ikaros (IKZF1), two members of the Ikaros family of zinc-finger transcription factors critical in B-cell development. KPG-818 showed outstanding in vitro anti-inflammatory properties and a broad spectrum of anti-proliferative activities as well as remarkable in vivo efficacy in animal models of multiple blood cancers. In the Phase Ib/IIa clinical study in SLE patients (trial ID: NCT04643067) completed in the United States, KPG-818 demonstrated good safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy. Currently, Phase I clinical trials (trial ID: NCT04283097) for the treatment of various blood cancers are being conducted in the United States. About Kangpu Biopharmaceuticals Kangpu Biopharmaceuticals, Ltd. is a clinical-stage company focused on the discovery and development of innovative therapeutics for the treatment of solid tumors, hematologic malignancies, autoimmune diseases, and inflammatory disorders through novel solutions including targeted protein ubiquitination and degradation. Kangpu Biopharmaceuticals has built a rich and solid pipeline of potential first-in-class and best-in-class drug candidates based on proprietary technologies, including NeoMIDESTM, SelPDEiS®, and X-SYNERGY®, developed and patented worldwide by the Company. For more information, please visit . Forward-Looking Statements The statement(s) made in this press release describing Kangpu Biopharmaceuticals' predictions, expectations, and objectives may be forward-looking statements within the meaning of applicable laws and regulations. These statements and expectations envisaged by the management are only estimates and actual results may differ materially from such expectations due to risks, uncertainties and other factors including, but not limited to, changes in regulatory and/or economic conditions, uncertain outcomes in these clinical studies, exposure to market risks, and other external and internal factors, which are beyond the control of Kangpu Biopharmaceuticals. SOURCE Kangpu Biopharmaceuticals

First Wave BioPharma to advance GI development pipeline with the expected addition of Phase 3 Latiglutenase celiac disease program and Phase 2 clinical programs built around Capeserod and AdrulipaseBOCA RATON, Fla., Dec. 27, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has entered a non-binding term sheet to sell its Niclosamide program for the treatment of inflammatory bowel diseases (IBD) such as ulcerative colitis and related conditions to an undisclosed biopharmaceutical company (the “Proposed Transaction”). The Proposed Transaction will enable First Wave BioPharma to focus its development resources on its three late-stage clinical programs: Capeserod, a selective 5-HT4 receptor partial agonist licensed from Sanofi; Adrulipase, a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency (EPI); and, after the closing of the recently announced potential business combination with ImmunogenX, Latiglutenase, a Phase 3-ready oral biotherapeutic for celiac disease. The non-binding term sheet includes a low seven-figure upfront payment to First Wave BioPharma for rights to Niclosamide, as well as economics related to future milestones and royalties. The transaction is expected to close in the first half of 2024. Additional details of the transaction will be disclosed upon finalization and execution of the definitive agreement. Upon execution of the definitive agreement, the completion of the transaction will be subject to, among other matters, satisfaction of the conditions negotiated therein, the buyer having secured adequate financing, and receipt of all third party (including governmental) approvals, licenses, consents, and clearances, as and when applicable. “This is a very exciting time in the evolution of First Wave BioPharma as we have recently reinvigorated our GI-focused clinical development pipeline with Phase 2-ready Capeserod from Sanofi and the pending addition of Phase 3-ready Latiglutenase,” stated James Sapirstein, President and CEO of First Wave BioPharma. “We plan to rapidly advance these programs in 2024 given the significant potential of each to address GI conditions for which no effective therapies currently exist. As a result, we made the strategic decision to streamline our development pipeline and are pleased to have entered a non-binding term sheet for Niclosamide, which has the potential to infuse First Wave with additional, non-dilutive capital.” Niclosamide is a prescription, non-systemic, small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections and has been safely used on millions of patients. The drug is a potential non-steroidal anti-inflammatory therapy for the treatment of mild-to-moderate inflammatory bowel diseases (IBD). First Wave BioPharma had previously conducted Phase 2 trials with niclosamide for the treatment of ulcerative proctitis/proctosigmoiditis (the most prevalent form of ulcerative colitis) and for the treatment of COVID gastrointestinal infections. The Company also has a Phase 2 open-IND for the treatment of immune checkpoint inhibitor-associated colitis and diarrhea in patients with metastatic cancer. Intellectual property for niclosamide formulations governing composition of matter and methods of use extends beyond 2040. About First Wave BioPharma, Inc. First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline with multiple late-stage clinical stage programs, including Capeserod, a selective 5-HT4 receptor partial agonist which First Wave is developing for gastrointestinal (GI) indications; the biologic Adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency; and it is anticipated that the Company will soon acquire Latiglutenase, a targeted, oral first-in-class biotherapeutic for celiac disease. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information visit www.firstwavebio.com. Forward-Looking Statements This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether a definitive agreement for the Proposed Transaction or a transaction with ImmunogenX and any concurrent financing or licensing transaction will be entered into; whether such transactions, or any other contemplated transaction, may be completed with different terms, in an untimely manner, or not at all; whether the Company will be able to realize the benefits of the Proposed Transaction described herein; the Company’s ability to integrate the assets and commercial operations contemplated to be acquired from ImmunogenX into the Company’s business; whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; whether the Company will be able to maintain compliance with Nasdaq’s continued listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition, the related settlement and their effect on the Company’s business, operating results and financial prospects; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware. For more information:First Wave BioPharma, Inc.777 Yamato Road, Suite 502Boca Raton, FL 33431Phone: (561) 589-7020info@firstwavebio.com Media contact:Tiberend Strategic Advisors, Inc.David Schemelia(609) 468-9325dschemelia@tiberend.com