Noxxon Pharma, a biopharmaceutical company developing proprietary therapeutics called Spiegelmers, has treated the first patient with its anti-hepcidin Spiegelmer lexaptepid pegol (NOX-H94) in a phase IIa proof-of-concept clinical trial to treat erythropoietin (EPO) hyporesponsive anemia in dialysis patients.
This is the fourth clinical trial with lexaptepid pegol. The multi-center, placebo-controlled study will examine the pharmacokinetics, pharmacodynamics, efficacy and safety of single and multiple doses of lexaptepid pegol in EPO-hyporesponsive dialysis patients with anemia.
Approximately 10% of the dialysis population has erythropoiesis-stimulating agent (ESA) resistant anemia, an unmet medical need that Noxxon now addresses with this study. Anemic dialysis patients that do not respond adequately to an ESA could benefit from the inhibition of hepcidin by lexaptepid pegol. A recent study by Noxxon already has shown significant increases in hemoglobin levels (>1g/dL) in response to lexaptepid pegol monotherapy in a subset of anemic cancer patients.
Lexaptepid pegol is a Spiegelmer that binds and neutralizes hepcidin, a peptide hormone that negatively regulates serum iron levels. High hepcidin levels, commonly found in dialysis patients, lead to iron restriction, also known as functional iron deficiency. This condition, in which iron is blocked inside its cellular stores and therefore unavailable for hemoglobin synthesis, ultimately results in anemia.