Hansa Biopharma AB announced positive results from the 12-month follow-up analysis of the NICE-01 trial, evaluating HNSA-5487, its next-generation immunoglobulin G (IgG)-cleaving molecule. The trial assessed IgG recovery, immunogenicity, and redosing potential, revealing rapid and robust IgG reduction.
Key Findings from the NICE-01 Trial
The NICE-01 trial demonstrated that HNSA-5487 achieved a reduction of IgG levels by more than 95% within hours after treatment. A 12-month follow-up showed IgG levels returning to the normal range six months post-initial dosing. These results align with the efficacy of imlifidase, Hansa Biopharma's first-generation IgG-cleaving enzyme.
Søren Tulstrup, President and CEO of Hansa Biopharma, stated, "There is mounting clinical evidence that faster and more robust IgG reduction is directly linked to more successful therapeutic outcomes in autoimmune and other diseases. We are very encouraged by these results that demonstrate HNSA-5487 can robustly and very rapidly reduce IgG levels, has redosing potential, and a favorable safety and tolerability profile."
Immunogenicity and Safety Profile
Notably, HNSA-5487 showed lower pre-treatment anti-drug antibody (ADA) levels and significantly reduced ADA responses compared to imlifidase, indicating an improved immunogenicity profile and potential for redosing. The drug also demonstrated consistent efficacy in nearly 100% of serum samples analyzed at six and 12 months after the initial dose.
The safety profile of HNSA-5487 was favorable, with no serious adverse events reported. The drug was well-tolerated among the 36 healthy adult participants in the double-blind, randomized, placebo-controlled trial.
Clinical Development Focus
Hansa Biopharma intends to focus clinical development of HNSA-5487 on chronic autoimmune diseases where IgG plays a critical role in disease pathology and acute phases. Initial clinical targets include myelin oligodendrocyte glycoprotein antibody disease (MOGAD), neuromyelitis optica (NMO), and myasthenia gravis (MG).
These conditions share a common underlying cause: misguided IgG antibodies. MOGAD affects 2 to 3.4 in every 100,000 people worldwide, with approximately 30% of cases occurring in children. NMO affects about seven in every 100,000 people in the US, with approximately 22,000 individuals living with the condition. Myasthenia gravis affects approximately 150 to 200 out of every million people globally.
Addressing Unmet Medical Needs
Despite the severity of these diseases, there remains a significant unmet medical need, with few advanced therapies available and no approved treatments for the acute phases. HNSA-5487's ability to effectively and rapidly reduce IgG levels could potentially address a range of debilitating symptoms associated with these conditions.
Trial Design
The NICE-01 trial was designed as a double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of HNSA-5487, administered as a single intravenous (IV) infusion. The trial included 36 healthy male and female adult participants.
