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Inipharm’s Development Candidate INI-822 Shows Improvements in Markers of Liver Homeostasis in Preclinical Studies

Data to be presented at the EASL Congress 2023 demonstrate positive changes in ALT and phosphatidylcholine content in rats fed a high fat diet

These changes are consistent with features seen in humans carrying protective forms of the HSD17B13 gene

Inipharm, a biopharmaceutical company focused on discovering and developing therapies for severe liver diseases, today announced that data on its development candidate INI-822, a small molecule inhibitor of HSD17B13, demonstrated improvements in key markers of liver homeostasis in rats fed a high fat choline-deficient diet. The data will be presented at the European Association for the Study of the Liver’s EASL Congress 2023, taking place June 21-24, 2023.

Key findings in rats dosed orally with INI-822 were statistically significant compared to controls and include the following:

  • Decreases in levels of ALT, a marker of liver injury.
  • Increases in hepatic phosphatidylcholine (PC) levels consistent with the observation of increased PC levels seen in humans with enzymatically inactive HSD17B13.
  • Increases in levels of HSD17B13 lipid substrates, consistent with inhibition of HSD17B13 enzymatic activity.

“Enzymatically inactive HSD17B13 has been shown to be protective in a range of liver diseases, so we believe that its inhibition in humans could provide significant clinical benefit. These in vivo data support that hypothesis and suggest the potential of INI-822 to recapitulate key features found in patients with the protective genetic variant of HSD17B13,” said Chuhan Chung, M.D., chief medical officer of Inipharm. “Our studies so far have shown that INI-822 potently and selectively inhibits HSD17B13, with an attractive toxicology and PK/ADME profile. We look forward to advancing INI-822 into clinical development.”

Poster details:

Title: Development of a target engagement biomarker for HSD17B13: Preclinical pharmacodynamic studies of small molecule inhibition of HSD17B13 by INI-822

Date: June 21, 2023

Time: 9:00 am

About HSD17B13 and INI-822

Numerous genetic association studies have confirmed that enzymatically inactive variants of the HSD17B13 protein are associated with 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 and is planned to begin clinical development this year.

About Inipharm

Inipharm is a biopharmaceutical company focused on discovering and developing therapies for severe liver diseases. Inipharm’s lead program is focused on the highly validated genetic target, HSD17B13. Extensive, consistent evidence shows that genetic variants resulting in inactive 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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