Hansa Biopharma's HNSA-5487 Shows Over 95% IgG Reduction and Redosing Potential in Initial Human Trial

Hansa Biopharma AB, based in Lund, Sweden, has revealed promising results from a 12-month follow-up analysis of the NICE-01 trial for HNSA-5487, their latest immunoglobulin G (IgG)-cleaving molecule. The trial was aimed at evaluating IgG recovery, immunogenicity, and the potential for redosing. The findings indicate a rapid and potent reduction in IgG levels, which plummeted by over 95% within hours of treatment. IgG levels returned to normal six months post-treatment, mirroring the efficacy of imlifidase, Hansa's first-generation enzyme. Importantly, no severe adverse events were reported, underscoring the safety and tolerability of HNSA-5487.

HNSA-5487 showed lower pre-treatment anti-drug antibody (ADA) levels and a significantly reduced ADA response compared to imlifidase, highlighting its favorable immunogenicity profile and potential for redosing. Nearly all serum samples from the trial exhibited similarly robust IgG reduction at six and 12 months post-treatment.

Søren Tulstrup, President and CEO of Hansa Biopharma, emphasized the critical link between faster, more robust IgG reduction and improved therapeutic outcomes in autoimmune and other diseases. He noted that the trial results demonstrate HNSA-5487's rapid efficacy in lowering IgG levels, potential for redosing, and favorable safety profile. Tulstrup believes HNSA-5487's distinctive profile offers transformative potential for addressing unmet needs in a variety of IgG-driven diseases, including autoimmune conditions that require better management of immune system attacks.

Hansa Biopharma plans to focus the clinical development of HNSA-5487 on chronic autoimmune diseases where IgG contributes to disease pathology, particularly during acute phases. The initial clinical targets include myelin oligodendrocyte glycoprotein antibody disease (MOGAD), neuromyelitis optica (NMO), and myasthenia gravis (MG). MOGAD affects 2 to 3.4 per 100,000 people globally, with about 30% of cases occurring in children. In the US, NMO affects approximately 7 per 100,000 people, with about 22,000 people living with the condition. MG affects 150 to 200 per million people worldwide, with an estimated 37 per 100,000 in the US.

These autoimmune conditions share a common cause: aberrant IgG antibodies. Despite the severity of these diseases, there remains a significant unmet medical need, with few advanced therapies available and no approved treatments for acute phases. HNSA-5487's ability to quickly and effectively reduce IgG levels positions it as a promising treatment for these debilitating conditions.

The NICE-01 trial was a double-blind, randomized, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of HNSA-5487 administered via a single intravenous (IV) infusion. The trial included 36 healthy adult participants, both male and female, and confirmed that HNSA-5487 was safe and well tolerated, with no serious adverse events.

Hansa Biopharma is committed to groundbreaking biopharmaceutical development, focusing on innovative treatments for rare immunological conditions. Their proprietary IgG-cleaving enzyme technology platform aims to address critical unmet needs across a range of applications, including transplantation, autoimmune diseases, gene therapy, and oncology. The company is listed on Nasdaq Stockholm under the ticker HNSA.