IBD98-M Approved for Phase IIa Clinical Trial in Italy.
09, Nov 2015
Holy Stone Healthcare Co., Ltd. (4194-TW) announced today that its developing new drug, IBD98-M, has been granted the approval to conduct a Phase IIa clinical trial in Italy by the Italian Medicines Agency (AIFA).
IBD98-M is indicated for inflammatory bowel disease (IBD) and has gained approval from the U.S. Food and Drug Administration (FDA) for a Phase IIa clinical trial. IBD98-M, utilized the HDD(Hyaluronan Drug Delivery)Technology developed by the company, is a new formulation and new combination drug formed with hyaluronic acid (HA) and 5-aminosalicylic acid (5-ASA).
Holy Stone Healthcare has made payments with a total of NTD 13.72 million to its CRO. It is estimated that the Phase IIa clinical trial will be completed by the end of 2016.