Hansa Biopharma announced high-level results from NICE-01, the first-in-human trial for HNSA-5487. Results showed the molecule was safe and well tolerated. Fast and complete depletion of immunoglobulin G (IgG) antibodies was observed at increasing doses in all subjects.

Pharmacokinetics (PK) was in line with expectations and pharmacodynamics (PD) (efficacy on IgG cleavage) showed a fast and complete cleavage of IgG to F(ab')2 - and Fc-fragments with increasing doses. NICE-01 is a double blind, randomized, placebo-controlled trial evaluating safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of HNSA-5487 administered as a single intravenous (IV) infusion. The trial included a total of 36 healthy male and female adult participants.

HNSA-5487 is the company's lead candidate in the Novel Immunoglobulin Cleaving Enzymes for repeat Dosing (NiceR) program. The NiceR program aims to develop next-generation enzymes with lower immunogenicity that would potentially allow for repeat dosing in a range of indications including IgG-driven autoimmune diseases where patients experience flares, transplantation where repeat dosing would be beneficial, gene therapy and on-line therapy.