NOXXON Pharma today announced the initiation of a Phase I clinical trial for NOX-H94, the Company's third compound to enter the clinic. NOX-H94 is a Spiegelmer® designed to treat anemia of chronic disease by targeting the peptide hormone hepcidin, the key regulator of iron metabolism. Hepcidin is up-regulated by acute and chronic inflammatory reactions resulting in "iron restriction", which means that iron is blocked inside cellular stores and not available for hemoglobin synthesis. This is in contrast to "iron deficiency", in which iron stores are depleted.
Subjects will first be administered escalating single doses of NOX-H94 and will then be tested with multiple doses. Both the intravenous and sub-cutaneous routes of administration will be tested. The primary objective of the study is to assess the safety and tolerability of NOX-H94 with a secondary objective to test pharmacokinetic/pharmacodynamic responses to the compound.
Mr. Iain Buchanan, Chief Executive Officer of NOXXON, commented: "The recent entry of NOX-H94 into human trials marks the third Spiegelmer® product in clinical development and underlines the transition that NOXXON has made to a company with clinical-stage assets. Preliminary data arising from this study suggest that NOX-H94 is safe, well tolerated and acts in a manner as predicted by preclinical studies. NOXXON will provide further updates on the progress of NOX-H94 and other compounds in its pipeline later in the year."
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