Holy Stone Healthcare Receives FDA Approval to Initiate Phase 1 study of IBD98-M
06, Aug 2014
Holy Stone Healthcare Receives FDA Approval to Initiate Phase 1 study of
IBD98-M for treatment of Inflammatory Bowel Disease.
Taipei, Taiwan –August 05, 2014 –Holy Stone Healthcare Co., Ltd. (HSHC) was recently notified by the US Food and Drug Administration for the approval of its Investigational New Drug (IND) 505(b)(2) application to conduct the PK and safety in Phase 1 clinical trials of IBD98-M for the treatment of inflammatory Bowel Disease.
IBD98-M uses its patented HDD (Hyaluronan Drug Delivery) Technology by a new combination therapy containing mesalamine and sodium hyaluronate for the treatment of mild to moderate ulcerative colitis. Mesalamine is an amino-salicylate non-steroidal anti-inflammatory drug and sodium hyaluronate is a mucosa supplement by combining these two components can facilitate the healing process of the inflamed area in colon and eliminate toxins that will trigger inflammation recurrences.