Hansa Biopharma (HNSA) Study Result summary

Study background and objectives

• HNSA-5487 is a next-generation IgG cleaving enzyme engineered for high potency, specificity, and safety, with a lower immunogenicity profile compared to imlifidase.

• The NICE-01 Phase 1 study was a double-blind, randomized, placebo-controlled trial enrolling 36 healthy volunteers to assess safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and redosing potential using single ascending doses.

• The study aimed to demonstrate rapid and robust IgG reduction, establish redosing potential, and included exploratory endpoints at 12 months.

Key results and findings

• HNSA-5487 reduced IgG levels by more than 95% within hours after a single dose, with levels returning to normal after six months.

• The immunogenicity profile was significantly improved, with lower anti-drug antibody responses compared to imlifidase, peaking at 1–2 months and declining by 6–12 months, supporting redosing potential.

• Redosing windows were identified at one week and at 6–12 months post-initial dose, with nearly 100% of samples at these intervals showing robust IgG reduction.

• No serious adverse events or increased infection risk were observed; the safety and tolerability profile was favorable and comparable to imlifidase.

• Efficacy in reducing total IgG levels was comparable to imlifidase.

Mechanism and advantages

• HNSA-5487 inactivates IgG by cleaving heavy chains, providing unmatched speed in reducing IgG compared to other modalities.

• The molecule is highly differentiated from FcRn inhibitors and other emerging therapies, offering rapid, profound, and broad IgG reduction across all subclasses.

• The immunogenicity profile supports effective redosing, with lower ADA responses than imlifidase.