ritivixibat (IPN60250) / Ipsen - LARVOL DELTA

Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Albireo | N=12 ➔ 24

Enrollment change • Hepatology

Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: Albireo | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Jun 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Hepatology

A3907, a systemic ASBT inhibitor, improves cholestasis in mice by inhibiting multi-organ bile acid transport and shows translational relevance to human (EASL-ILC 2023) - "A3907 is the first oral systemic ASBT inhibitor that acts at the level of the intestine, liver and kidney and robustly attenuates cholestatic liver damage in experimental models. A3907 was well-tolerated in human subjects at doses reaching systemic exposures comparable to those required for therapeutic effects in animal models of cholestasis. Collectively these results highlight the promising translational potential of A3907 for the treatment of cholestatic diseases."

Preclinical • Biliary Cancer • Cholestasis • Fibrosis • Hepatology • Immunology • Liver Failure • Oncology • ABCB4

A3907, a systemic ASBT inhibitor, improves cholestasis in mice by multi-organ activity and shows translational relevance to humans. (PubMed, Hepatology) - "Plasma exposure of A3907 in humans was within the range of systemic concentrations that achieved therapeutic efficacy in mouse.The systemic ASBT inhibitor A3907 improved experimental cholestatic disease by targeting ASBT function at the intestinal, liver and kidney levels, resulting in marked clearance of circulating BAs and liver protection. A3907 is well-tolerated in humans, supporting further clinical development for the treatment of cholestatic liver diseases."

Journal • Preclinical • Cholestasis • Hepatology • Liver Failure • ABCB4

Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: Albireo | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology

Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: Albireo | Trial completion date: Jun 2023 ➔ Jun 2024 | Trial primary completion date: Jun 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Hepatology

Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: Albireo

New P2 trial • Hepatology

SYSTEMIC ASBT INHIBITION WITH A3907 STIMULATES URINARY EXCRETION OF BILE ACIDS AND HALTS LIVER DISEASE PROGRESSION IN BILE-DUCT–OBSTRUCTED MICE (AASLD 2022) - "Inhibition of renal ASBT with A3907 improved the general condition and liver phenotype of mice with induced obstructive cholestasis, by promoting urinary secretion of BAs. A3907 may have therapeutic potential for patients with cholestatic liver diseases."

Preclinical • Cholestasis • Fibrosis • Hepatology • Immunology • Inflammation • Liver Failure • BCL2L1 • HIF1A • HMOX1 • KRT19 • KRT7 • PPARG