Inipharm to Present Phase 1 Pharmacokinetic Data for INI-822

Inipharm, a biopharmaceutical company dedicated to creating treatments for fibrotic liver diseases, has announced its plans to present new clinical and preclinical data for its Phase 1 small molecule inhibitor, INI-822, at the European Association for the Study of the Liver’s EASL Congress 2024. This event is scheduled for June 5-8 in 2024.

The clinical data to be showcased includes findings from tests conducted on healthy volunteers. These tests revealed that the doses of INI-822 achieved plasma levels expected to inhibit the protein HSD17B13. This protein's inactive variant is linked to a decreased risk of severe liver diseases such as metabolic dysfunction-associated steatohepatitis (MASH), also known as NASH. Furthermore, the results showed that INI-822 has a half-life that supports once-daily oral dosing, making it feasible for future clinical studies involving MASH patients.

Dr. Chuhan Chung, Inipharm’s Chief Medical Officer, expressed optimism about the progress seen in the Phase 1 study involving healthy volunteers. He mentioned that the company is preparing to move into the next phase of the trial, which will focus on evaluating the safety and pharmacokinetics of INI-822 in MASH patients. Dr. Chung highlighted the significance of targeting HSD17B13 with an orally administered small molecule drug, given the positive clinical outcomes associated with the protein's inactive variant.

Additionally, Inipharm will present preclinical data from studies conducted on rats. The findings indicate that treatment with INI-822 led to reduced levels of alanine transaminase (ALT), a marker of liver damage, in rats that were fed a CDAA-HFD diet. This diet is known to swiftly induce signs of MASH, including elevated liver enzyme levels. Moreover, rats on this diet treated with INI-822 showed a dose-dependent increase in hepatic phosphatidylcholines (PCs). These PCs are crucial for cell membrane stability and are found in higher levels in liver biopsies of individuals with the inactive form of the HSD17B13 protein.

Poster presentations at the EASL Congress will include:
1. Clinical pharmacokinetics of INI-822, a small molecule inhibitor of HSD17B13 (Abstract Number: 1310)
2. Inhibition of HSD17B13 by INI-822 phenocopies the hepatic lipidomic profile of humans with the protective allele (Abstract Number: 932)

HSD17B13 and INI-822 have been the focus of multiple human genetic association studies, which have consistently shown that inactive variants of the HSD17B13 protein are linked to a reduced risk of advanced fibrotic disease in various liver conditions, including metabolic, alcoholic, and viral liver diseases. INI-822 is Inipharm’s first developmental candidate and represents a promising advancement in the treatment of severe liver diseases.

Inipharm is committed to discovering and developing therapies for severe liver diseases. The company’s primary programs are centered on the genetically validated target, HSD17B13. Extensive research has demonstrated that genetic variations in HSD17B13 expression correlate with significantly lower rates and reduced severity of multiple liver diseases. Using this knowledge, Inipharm is developing a pipeline of small-molecule therapies aimed at targeting the activity of the HSD17B13 protein.