Inflammatory bowel diseases (IBD), which consists of ulcerative colitis (UC) and Crohn's disease (CD), is are characterized by chronic inflammation of the gastrointestinal tract in genetically susceptible individuals exposed to environmental risk factors that affect 5 million people worldwide (1.4 million in the U.S. alone).
IBD98-M, a Delayed-Release Capsule, containing mesalamine, and sodium hyaluronate, is being developed by Holy Stone Healthcare (Holy Stone) as a combination therapy for treatment of patients with mild to moderate UC. The mechanisms of action of IBD98-M Delayed-Release Capsule is as a combination therapy are to combine the therapeutic effects of mesalamine and a barrier effect of sodium hyaluronate to protect the damaged mucosa. Mesalamine has been widely utilized for decades as an anti-inflammatory agent, in treating mild to moderate active CD and UC. At the same time, sodium hyaluronate may act as a protective barrier to the lining of the colon affected by UC, and therefore provides additional therapeutic benefits either by enhancing the efficacy of mesalamine or allowing a reduction of mesalamine dose and its associated toxicity.
2014-08-06 Holy Stone Healthcare Receives FDA Approval to Initiate Phase 1 study of IBD98-M IBD98-M product was approved by the US Food and Drug Administration for the Investigational New Drug (IND) 505(b)(2) application to conduct the PK and safety in Phase 1 clinical trials.
2015-11-09 Holy Stone Healthcare’s IBD98-M Approved for Phase IIa Clinical Trial in Italy It was announced that IBD98-M product has been granted the approval to conduct a Phase IIa clinical trial in Italy by the Italian Medicines Agency (AIFA) on the 6th Nov., 2015.