Inipharm has started dosing in a 12-week proof-of-concept clinical study evaluating its oral hydroxysteroid 17-beta-dehydrogenase 13 (HSD17B13) inhibitor, INI-822, in adults with metabolic dysfunction-associated steatohepatitis (MASH).
The placebo-controlled, double-blind trial aims to enrol approximately 50 MASH patients. It will measure safety, pharmacokinetics, and tolerability and evaluate changes in MASH-related biomarkers and fibrosis, using FibroScan technology.
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Designed to inhibit the activity of HSD17B13, INI-822 is currently the only small-molecule inhibitor of this target in clinical development.
Genetic studies have shown that variants decreasing HSD17B13 enzyme activity lower the risk of progressive fibrotic liver diseases, including a 50% to 60% reduction in the risk of transition from fatty liver to fibrotic MASH or cirrhosis.
Protective HSD17B13 variants also appear to mitigate risk from the PNPLA3 I148M risk variant, which is significant as patients with this variant may not show adequate response to GLP-1 agonists.
Inipharm chief medical officer Chuhan Chung said: “Our ongoing clinical trial of INI-822 has generated encouraging biomarker and target engagement data in MASH patients after only 28 days of dosing, demonstrating its potential to meaningfully impact the course of MASH.
“This 12-week study will build on that data and provide us even greater insight into how INI-822 may address MASH features such as fibrosis and is designed to position us to enter Phase IIb studies.”
Inipharm CEO Brian Farmer said: “Injectable RNAi-based approaches to targeting HSD17B13 have generated encouraging data in MASH, bolstering our confidence in the target and our programme.
“That noted, we believe an oral small molecule that inhibits the enzymatic activity of HSD17B13, rather than knocking it down, may better reflect the physiology of the naturally occurring protective variant, in addition to providing more convenient dosing for patients.”
