Date: 2015-10-05
Type of information: Results
phase: preclinical
Announcement: results
Company: Protalix BioTherapeutics (Israel)
Product: PRX-106 (biosimilar version of etanercept)
Action
mechanism: fusion protein. PRX-106 is an orally administered, plant cell-expressed recombinant anti-TNF fusion protein that successfully concluded Phase I clinical trial.
Disease: NASH (non-alcoholic steatohepatitis)
Therapeutic area: Liver diseases - Hepatic diseases
Country:
Trial details:
Latest
news: * On October 5, 2015, Protalix BioTherapeutics announced pre-clinical data for PRX-106 in Non-alcoholic Steatohepatits (NASH), a liver disease characterized by an accumulation of fat, along with inflammation and degeneration of hepatocytes. In preclinical studies, PRX-106 alleviated immune-mediated hepatitis and reduced interferon gamma levels in a concanavalin A (ConA) inflammatory mouse model. In a high fat diet model (NASH) PRX 106 demonstrated a reduction of liver enzymes, ALT and AST, reduction of serum triglycerides, along with a trend for reduction of liver fat. The safety of orally administered PRX-106 was assessed in a 14-day repeated administration study in rats. Three doses representing up to 5x of the highest intended clinical dose were evaluated, along with a control arm. No adverse clinical symptoms presented, with all blood parameters and weight gain persistent and normal. Furthermore, there were no abnormalities in gross necropsy pathology seen in any of the animals. In addition, a two months toxicology study to support longer duration clinical studies was successfully completed. No treatment-related adverse reactions were observed among all experimental groups. PRX-106 has also completed a Phase I clinical trial in healthy volunteers conducted at the Hadassah-Hebrew University Medical Center in Israel. The results from this trial demonstrated that PRX-106 is safe and well tolerated, and showed biological activity in the gut and inducement of regulatory T cells. In addition to inflammatory bowel disease (IBD), Protalix BioTherapeutics is now evaluating NASH as a potential indication for a proof of concept clinical trials in patients for PRX-106.
