Advancing liver disease treatment with INI-822

A landmark discovery in liver disease research

In 2018, New England Journal of Medicine reported that a variant of the gene HSD17B13 offers protection against advanced liver diseases, including metabolic dysfunction-associated steatohepatitis (MASH), alcoholic liver disease, and hepatocellular carcinoma. This discovery has led to new therapeutic approaches aimed at reducing liver damage by mimicking the gene’s protective effects. The full article can be found here.

INI-822: A novel therapeutic approach

Inipharm has developed INI-822, a small molecule designed to replicate the protective function of the HSD17B13 gene variant. By reducing liver scarring (fibrosis), INI-822 may prevent the progression of severe liver diseases. The ongoing clinical trials aim to evaluate its safety, tolerability, and pharmacokinetics in human subjects.

The Inipharm Team can be contacted directly to find out more about INI-822 or to refer patients at: trials@inipharm.com

Study eligibility criteria

Participants in the study will receive free FibroScans® and study-related care. No biopsy is completed as part of this study.

Key inclusion criteria

• 18-65 years of age (inclusive)
• Suspected MASH (biopsy, non-invasive, or clinical) Note: FibroScan® will be completed as part of study screening.
• BMI of 18-40 kg/m² (inclusive)

Key exclusion criteria

• Cirrhosis
• Consuming > 4 standard alcoholic drinks on any single day

For the full list of eligibility criteria, click here.

Snapshot of clinical trial progress

INI-822 has successfully completed preclinical studies, which confirmed its safety profile and biological activity. The drug has now progressed to Phase 1 clinical trials, where it is being evaluated in patients with MASH. The primary objectives of this phase are to assess the medication’s safety, tolerability, and metabolism.

• Preclinical (Completed)

Laboratory research and animal studies completed to evaluate safety and biological activity.

• Phase 1 (First part – Completed)

Medication (INI-822) given to 56 healthy volunteers. It was well tolerated with no serious side effects.

• Phase 1 (Now)

Recruiting participants with MASH or suspected MASH to evaluate the medication’s safety and tolerability safety before progressing to larger studies.

Contact Information

To refer potential participants to the appropriate site or to find out more information on this study, please contact:

Inipharm Clinical Research Team: trials@inipharm.com

Study Locations
The INI-822 clinical trial is being conducted at the following sites:

South Australia
CMAX Clinical Research (Adelaide)

Queensland
Princess Alexandra Hospital (Brisbane)

New South Wales
Nepean Hospital (Kingswood)
Royal Prince Alfred Hospital (Sydney)

Victoria
St. Vincent’s Hospital Melbourne (Melbourne)
The Alfred Hospital (Melbourne)

Note: This study has been approved by Bellberry and CALHN Human Research Ethics Committees (HRECs).
Bellberry HREC: bellberry@bellberry.com.au or +618 8361 3222
CALHN HREC: Health.CALHNResearchEthics@sa.gov.au or +618 7117 2224

Please note: This research is not sponsored by Diabetes Australia.