INI-822 / Inipharm - LARVOL DELTA

A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH (clinicaltrials.gov) - P1 | N=168 | Recruiting | Sponsor: Inipharm Australia Pty Ltd | N=104 ➔ 168 | Trial completion date: Jun 2025 ➔ Oct 2026 | Trial primary completion date: May 2025 ➔ Sep 2026

Enrollment change • Trial completion date • Trial primary completion date • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

HSD17B13 loss-of-function protects against steatosis-induced hepatic phosphatidylcholine depletion by promoting polyunsaturated fatty acid retention in humans in vivo and in experimental models (EASL 2025) - "We tested whether targeting HSD17B13 with a small molecule inhibitor, INI-822, affects PC metabolism using two models: in vitro, a primary human liver-on-a-chip system challenged with high-fat media for 20 days; and in vivo, Zucker obese rats fed either an atherogenic diet or a choline-deficient, L-amino acid-defined high-fat diet for 21 days... In humans, HSD17B13 rs72613567:TA prevents MASLD-induced hepatic PUFA-PC depletion by retaining PUFAs within the liver. Pharmacological inhibition of HSD17B13 recapitulates the human phenotype in vitro and in vivo. These findings suggest that hepatic PC enrichment is central to the protective effects associated with HSD17B13 loss-of-function."

Preclinical • Dyslipidemia • Fibrosis • Hepatology • Immunology • Liver Failure • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

A Study of INI-822 in Healthy Volunteers and Participants with Non-alcoholic Steatohepatitis (NASH) or Presumed NASH (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Inipharm Australia Pty Ltd | Trial completion date: Dec 2024 ➔ Jun 2025 | Trial primary completion date: Nov 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

A Study of INI-822 in Healthy Volunteers and Participants With Non-alcoholic Steatohepatitis (NASH) or Presumed NASH (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Inipharm Australia Pty Ltd | Trial completion date: Jul 2024 ➔ Dec 2024 | Trial primary completion date: May 2024 ➔ Nov 2024

Trial completion date • Trial primary completion date • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

Clinical pharmacokinetics of INI-822, a small molecule inhibitor of HSD17B13 (EASL-ILC 2024) - "The small molecule HSD17B13 inhibitor, INI-822, achieved clinical plasma exposures that exceeded concentrations projected to inhibit HSD17B13 based on preclinical models. Single ascending dose PK in healthy subjects appeared to achieve dose-proportional maximal plasma concentrations and exposure (AUC). The half-life of INI-822 is suitable for once daily dosing in future clinical trials of MASH subjects."

Clinical • PK/PD data • Fibrosis • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Immunology • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Oncology • Solid Tumor

Inhibition of HSD17B13 by INI-822 phenocopies the hepatic lipidomic profile of humans with the protective allele (EASL-ILC 2024) - "HSD17B13 inhibition with INI-822 decreased liver transaminases and led to increased hepatic PC content in Zucker rats on metabolic diets. HSD17B13 inhibition led to lipidomic changes consistent with those found in patients with the loss-of-function protective allele."

Fibrosis • Gastrointestinal Cancer • Hepatology • Immunology • Liver Cancer • Liver Cirrhosis • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Oncology • Solid Tumor

Inipharm Initiates Dosing in Phase 1 Study of Its Small Molecule Inhibitor of HSD17B13 (Businesswire) - "Inipharm...announced that it has begun dosing in a Phase 1 study of INI-822, its orally-delivered small molecule inhibitor of HSD17B13. INI-822, believed to be the first small molecule inhibitor of HSD17B13 to advance to clinical development, is under development for fibrotic liver diseases, including non-alcoholic steatohepatitis (NASH)....The randomized, double-blind, placebo-controlled Phase 1 study will enroll 96 participants in three parts. Parts A and B will enroll approximately 72 healthy volunteers, and Part C will enroll 24 participants with NASH or presumed NASH."

Trial status • Non-alcoholic Steatohepatitis

A Study of INI-822 in Healthy Volunteers and Participants With Non-alcoholic Steatohepatitis (NASH) or Presumed NASH (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Inipharm Australia Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Non-alcoholic Steatohepatitis