Zhiyi Biotech Initiates Phase III Clinical Trial for SK08 in China
Release Time: 2023-09-01
Recently, Zhiyi Biotech obtained the approval from NMPA to commence the pivotal phase III clinical trial for its first LBP candidate SK08 to treat irritable bowel syndrome with diarrhea (IBS-D). The Phase II clinical trial has demonstrated the safety and efficacy of SK08 in IBS-D patients with overall improvement in both abdominal pain and diarrhea symptoms. Based on this encouraging result, Zhiyi is planning to accelerate the Phase III clinical trial of SK08 in hope of benefiting IBS-D patients as soon as possible.
The launch of Phase III clinical trial further strengthens Zhiyi’s leading position in the field of LBP.
About SK08
SK08, the lead drug candidate in Zhiyi’s pipelines, is the first LBP developed on a unique bacterial strain Bacteroides Fragilis. It is also the first innovative LBP in China to enter phase III clinical trial. In addition to IBS, SK08 has multiple indications in clinical stage, including UC and tumors, and is expected to become the first LBP to be launched in China.
About IBS
IBS is a common and refractory digestive disease that seriously affects the work, life and mental health of patients. The global incidence rate was 4.1% – 10.1%, and the overall prevalence rate in China was 1.4% – 11.5%. The treatment market for IBS was $2.2 billion US dollars in 2021 and is expected to reach $3.8 billion in 2027, at a compound annual growth rate (CAGR) of 9.54%. At present, there is no radical therapy and few effective drugs for IBS. Therefore, the need for effective drugs is urgent, while LBP is promising on this area.