Approval for Clinical Trials of SK08
Release Time: 2019-11-25
SK08 is clinically approved by NMPA as Category 1 of Therapeutic Biological Products, which aims at indications IBS and UC.
SK08 is a live bacteria drug that firstly uses Bacteroides fragilis to develop new Live Biotherapeutics in the world. Preclinical studies show that SK08 was safe and has the potential to be effective for therapeutic, which will be a new valuable treatment provided for IBS/UC patients clinically.
SK08 is one of the few live bacteria drugs using new strain as well as entering the clinical stage in the world. It is an important breakthrough for the development of live bacteria drugs in China. The research team has completed lots of innovative work on strain isolation and identification, strain safety evaluation, pharmacokinetic, pharmacological, and CMC studies as well as the related microbiome.
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About IBS
IBS, which stands for Irritable Bowel Syndrome, is a common digestive system disease. The IBS prevalence in global is 9.8% to 12.8% and the overall prevalence in China is 6.5%. The pathogenesis remains unclear but is considered related to altered gastrointestinal motility, brain-gut interactions, intestinal inflammation, and intestinal flora. There is no effective treatment for IBS, which affects the patient’s quality of life and medical burden.
About UC
UC stands for Ulcerative Colitis, which is a long-term condition that results in inflammation and ulcers of the colon and rectum and lacks effective treatment. The prevalence is high in North America and Europe that more than 0.3% and increased rapidly in China over the past 30 years resulting in more than 1 million patients in 2015-2025 by estimating. For mild-to-moderate ulcerative colitis patients, long-term use of 5-ASA has serious adverse effects, while corticosteroids are unable to maintain remission and have serious side effects, there is still an urgent clinical need for drugs.