News: The Phase III clinical trial of SK08 was approved and subject initiation recruitment
Release Time: 2024-06-12
On 16th March, 2024,the Phase III clinical trial of SK08, an innovative live biotherapeutic product (LBP) developed by Zhiyi Biotech, was complete the first subject enrollment.This key clinical study on diarrhea induced irritable bowel syndrome with diarrhea (IBS-D) is led by Professor Chen Minhu/Professor Xiao Yinglian from the First Affiliated Hospital of Sun Yat sen University. It will be conducted in more than 50 research centers nationwide and is currently being rapidly and orderly promoted. SK08 is China’s first live biopharmaceutical (LBP) developed using a new generation of probiotics to enter clinical Phase III. The smooth implementation of this critical clinical trial will promote the early launch of the product, benefiting IBS patients.
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.