LISCure Biosciences, a company that develops medicines for patients, shared news on November 5 that they have started giving patients the first dose of LB-P8, a new treatment being tested in a global Phase 2 trial. LB-P8 is being studied for Primary Sclerosing Cholangitis (PSC), a rare and worsening disease that affects the bile ducts in the liver, causing inflammation and scarring. Right now, there are no approved treatments for PSC, which shows how urgent the need for new options is.
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LB-P8 is a new type of medicine that targets the connection between the gut and the liver to lower inflammation and scar tissue. Early research and a Phase 1 trial have shown that LB-P8 is safe to use and shows some promise in helping patients. It has also been helpful for people with inflammatory bowel disease, which is common in almost 80% of PSC patients. This extra benefit makes LB-P8 stand out compared to other new treatments being studied.
LB-P8 has already caught the attention of government health agencies. In 2022, the U.S. Food and Drug Administration gave it Orphan Drug Designation for treating PSC, which means it’s being considered for rare diseases. In 2024, it got Fast Track status, which speeds up the review process. Recently, the European Medicines Agency’s group for rare medicines gave a positive opinion, suggesting LB-P8 should get Orphan Drug Designation in Europe, which brings it closer to approval there.
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The Phase 2 trial, which is listed under ClinicalTrials.gov with the number NCT06699121, will take place at 28 medical centers across the United States and Europe. This study will check how safe and effective LB-P8 is for PSC patients, which will help shape future steps in developing the medicine.
Hwasup Chin, the CEO of LISCure, said that PSC is a major area where there are no approved treatments and that this trial is an important step for patients and doctors. He also mentioned that the company is working on another project, ExoPN-101, which helps deliver medicines across the blood-brain barrier, as part of their mission to create strong, effective treatments for people around the world.
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