BELLEVUE, Wash. & SAN DIEGO--(BUSINESS WIRE)-- Inipharm, a biopharmaceutical company focused on developing therapies for fibrotic liver diseases, today announced upcoming presentations of clinical and preclinical data from INI-822, the company’s Phase 1 small molecule inhibitor of HSD17B13, currently in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), also known as NASH. The data will be presented at the European Association for the Study of the Liver’s EASL Congress 2024, taking place June 5-8, 2024.

Clinical data to be presented demonstrate that doses of INI-822 tested in healthy volunteers achieved plasma exposures that are anticipated to inhibit HSD17B13, a protein whose inactive variant is associated with protection from advanced forms of liver diseases such as MASH. In addition, exposures occurred with a half-life that will enable once daily oral dosing in future clinical studies of participants with MASH.

“We are encouraged by the findings to date in healthy volunteers in our Phase 1 study as we move forward to the next portion of our trial, which will evaluate safety and pharmacokinetics in a cohort of MASH patients,” said Chuhan Chung, MD, chief medical officer of Inipharm. “While we have seen promising improvements in the MASH field, the opportunity to target HSD17B13 with an orally delivered small molecule drug remains highly relevant given the improved clinical outcomes associated with the HSD17B13 inactive variant.”

Inipharm will also present data showing that that INI-822 treatment led to decreased levels of alanine transaminase (ALT), a biomarker indicative of liver damage, in rats fed CDAA-HFD, a diet known to rapidly induce MASH signs including increased liver enzyme levels.

In addition, rats on CDAA-HFD diet treated with INI-822 demonstrated a dose-dependent increase in hepatic phosphatidylcholines (PCs), the major species of phospholipids that play a key role in cell membrane stability. These included PCs that have been shown to be elevated in liver biopsies from individuals with the inactive form of the HSD17B13 protein.

Poster details:

Abstract Title: Clinical pharmacokinetics of INI-822, a small molecule inhibitor of HSD17B13
Abstract Number: 1310

Abstract Title: Inhibition of HSD17B13 by INI-822 phenocopies the hepatic lipidomic profile of humans with the protective allele
Abstract Number: 932

About HSD17B13 and INI-822

Multiple human genetic association studies have confirmed that enzymatically inactive variants of the HSD17B13 protein are associated with a reduced risk of developing more advanced fibrotic disease in metabolic, alcoholic, and viral liver diseases. INI-822, a small molecule inhibitor of HSD17B13, is Inipharm’s first development candidate.

About Inipharm

Inipharm is a biopharmaceutical company focused on discovering and developing therapies for severe liver diseases. Inipharm’s lead programs are focused on the highly genetically validated target, HSD17B13. Extensive, consistent evidence that genetic variants in expression of HSD17B13 are associated with significantly lower rates and severity of multiple liver diseases. Building on these novel insights into the biologic activity of HSD17B13, Inipharm is advancing a pipeline of small-molecule therapies that target the activity of this protein.

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