The first patient in a Phase 2a trial of BOS-580 as a treatment for nonalcoholic steatohepatitis (NASH) was recently dosed. Boston Pharmaceuticals, the developer of the drug, aims to address an unmet medical need with their new therapy, as NASH patients currently face a lack of treatment options.
First, let’s take a look at what NASH is. Nonalcoholic steatohepatitis affects those who drink very minimally or not at all, causing an accumulation of fat in the liver. This leads to inflammation and scarring which may go on to impact liver function. Currently, this condition affects up to 25% of Americans but still faces an unmet medical need. While research is being conducted to fill this gap, the treatment options that exist now are lowering cholesterol, losing weight, controlling diabetes, avoiding alcohol, and maintaining a healthy diet and exercise regimen.
Symptoms of NASH include:
- Swelling in the legs and abdomen
- Mental confusion
- Loss of appetite
- Abdominal pain
- Spider-like blood vessels
About the Trial
This Phase 2a trial will be randomized, placebo-controlled, blinded, and run for 12 weeks. Patients who have been diagnosed with both nonalcoholic fatty liver disease (NAFLD) and NASH will participate. Researchers will be evaluating BOS-580’s pharmacokinetics, safety, and tolerability.
The participants will randomly be placed into different groups with varying dosages of BOS-580 or a placebo. The first patient already received their dose, with other participants soon to follow.
BOS-580 is administered via subcutaneous injection, and it is a variant of human fibroblast growth factor 21 (FGF21). It is able to regulate numerous metabolic pathways, helping patients to see a decrease in liver fat and aid inflammation and damage to the liver.
If approved, it could offer to fill an unmet medical need faced by NAFLD and NASH patients.
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