The FDA has recently provided 89bio with guidance for their upcoming clinical trial of BIO89-100, a treatment for nonalcoholic steatohepatitis (NASH). The trial will advance as planned, beginning in the second quarter of this year.
About the Trial
The Phase 2b trial is titled ENLIVEN and will test the efficacy and safety of a liquid form of BIO89-100. The trial is designed to be multi-center, placebo-controlled, and double-blind. About 200 patients who have been diagnosed with stage 2 or 3 NASH will participate in the trial, all of whom will receive either one of two different doses every week, one dosage of BIO89-100 every other week, or a placebo every other week. This will last for 24 weeks and be followed by an extension study for an additional 24 weeks.
Researchers will focus on the primary endpoints:
- Two key histology-based endpoints of NASH resolution with no progression in fibrosis
- Improvements in fibrosis without any disease progression
This trial comes after positive data from a Phase 1b/2a trial. Researchers are very excited by the data so far, and they hope that future results are just as positive. BIO89-100 has the potential to address an unmet need in the rare disease community and give NASH patients a treatment option.
About NASH
Nonalcoholic steatohepatitis is characterized by an accumulation of fat in the liver that results in inflammation and liver damage. It impacts those who drink very little or not at all. If left untreated, it can lead to cirrhosis and liver failure, mimicking the disease that affects heavy drinkers. NASH sees symptoms like jaundice, weakness, fatigue, itching, swelling in the legs and abdomen, mental confusion, weight loss, loss of appetite, nausea, vomiting, abdominal pain, and spider-like blood vessels. All of these effects are the result of a buildup of fat, but doctors are unsure as to why this occurs. They have only identified a number of risk factors: type 2 diabetes, obesity, metabolic syndrome, and high cholesterol. Because these are the only understood contributing factors, they also influence treatment. Doctors will suggest that one loses weight, avoids alcohol, maintains a healthy diet and exercise schedule, controls diabetes, and lowers cholesterol.
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