平台資產
IBD98-M
IBD98-M
An oral, multi-layer coated pellet combines HA and mesalamine for targeted colonic delivery.
• Mode of Action: Forms a resorbable HA barrier over inflamed mucosa while delivering mesalamine locally
• Clinical Status: Phase IIa showed significant symptom relief with a reduced drug burden; Phase IIb/III in preparation
IBD98-M, a Delayed-Release Capsule, containing mesalamine, and sodium hyaluronate, is being developed by HylMusa™ platform 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. 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.
• Mode of Action: Forms a resorbable HA barrier over inflamed mucosa while delivering mesalamine locally
• Clinical Status: Phase IIa showed significant symptom relief with a reduced drug burden; Phase IIb/III in preparation
IBD98-M, a Delayed-Release Capsule, containing mesalamine, and sodium hyaluronate, is being developed by HylMusa™ platform 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. 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.
