LISCure Biosciences Announces FDA Clearance of IND Application to Initiate a Phase 2 Study of LB-P8 for Primary Sclerosing Cholangitis (PSC)
- Represents first ever live biotherapeutic product to receive IND clearance for PSC
- Phase 2 clinical trial will evaluate the safety and efficacy, including clinical endpoints of LB-P8
PSC is a rare, chronic, cholestatic liver disease with very high unmet medical needs where there are no approved drugs. PSC can benefit from microbiome drugs because PSC is linked to the "gut-liver" axis and is strongly associated with total gastrointestinal risk and inflammatory bowel disease (IBD). LB-P8, designed to treat inflammation and fibrosis and to modulate bile acids, is expected to perform significantly well in clinical trials and hold a high position of success rate in drug development.
LISCure confirmed the safety, tolerability, and key biomarkers of LB-P8 in a Phase 1 study and received Orphan Drug Designation (ODD) for the treatment of PSC from the
"We are thrilled to obtain IND clearance to investigate LB-P8 for patients with PSC and are excited about the prospects of what this new class of medicines may mean for patients in need," said Hwasup Chin, Chief Executive Officer of LISCure Biosciences. "LB-P8 is receiving considerable attention from patient advocacy, physicians, companies, and other stakeholders. To meet their expectations, we will expedite development and offer new treatment opportunities to patients expeditiously."
About LISCure Biosciences
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