Boston Pharmaceuticals has released positive Phase IIa results for BOS-580, its investigational, proprietary, long-acting fibroblast growth factor 21 (FGF21) analog for the treatment of non-alcoholic steatohepatitis (NASH).
The B-Flexion portfolio company licensed global development and commercialization rights to the genetically engineered FGF21 analogue, formerly LLF580, from Swiss pharma giant Novartis (NOVN: VX) in 2020 for use in NASH.
The study suggested promising results for monthly and bi-weekly doses of BOS-580, which achieved statistically significant reduction in liver fat content, an exploratory endpoint in the trial of phenotypic NASH patients. Statistically-significant reductions in additional exploratory endpoints, including biomarkers of liver injury and fibrosis, were also observed. In the trial, a low discontinuation rate due to treatment-emergent adverse events was observed. The most common adverse events in patients treated with BOS-580 were gastrointestinal in nature, mild to moderate, and transient.
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