SEOUL, South Korea, Sept. 30, 2021 /PRNewswire/ -- LISCure Biosciences ("LISCure") announced that it has received approval for a global phase 1 clinical trial for two programs, LB-P6 and LB-P8, targeting autoimmune disease and non-alcoholic steatohepatitis (NASH), respectively. This achievement is significant in that it will be the first global clinical trial among the microbiome treatments for rheumatoid arthritis and NASH indications.
The most noteworthy part is that LB-P6 has no toxic effects, even after long-term administration, as no side effects were found compared to existing rheumatoid arthritis treatments. The effect of LB-P6 was found to be equal to or greater than that of the first-line treatment for rheumatoid arthritis in animal models. In addition, the company explains that it is possible to expand indications because therapeutic effects on other autoimmune diseases, such as psoriasis, have been clearly observed.
LB-P8 has demonstrated similar or better efficacy through non-clinical models comparable to other candidate treatments in a phase 3 clinical trial, and no side effects were observed. LISCure signed a Know-How License Agreement and Stock Purchase Agreement with Mayo Clinic for liver disease programs this year, and a joint research program is currently in progress.
LISCure will confirm the safety and key indicators of both programs in the first phase of this clinical trial and will start a global phase 2 clinical trial next year. Since LB-P6 is a candidate substance that is expected to have therapeutic effects on various autoimmune diseases, LISCure will conduct a phase 2 trial not only for patients with chronic diseases but also for autoimmune diseases that have high unmet medical needs. LB-P8 has entered the final stage of the study on its mechanism of action, and through additional mechanism studies, anti-fibrosis and tissue necrosis inhibitory effects have been confirmed in rare hepatic biliary diseases.
A LISCure official said, "In terms of safety, both pipelines are highly anticipated in that they have received a review opinion from the regulatory authority that they are safe, and receiving a lot of attention from overseas research institutes and pharmaceutical companies. We plan to develop them as the world's first microbiome treatments for rheumatoid arthritis and NASH."
LISCure is a biotech company that develops new microbial-based drugs and has a number of pipelines focusing on oncology, metabolic diseases, autoimmune diseases, and neurosciences. Based on the company's unique platform technology, it focuses on two business areas, bacteria-mediated immunotherapy and microbiome therapeutics, and is making various new R&D-oriented attempts in microbiology. LISCure is expected to conduct pre-clinical studies with the next generation of microbiome treatments, along with a new concept of anti-cancer therapy entering a clinical trial in the US.