In the NICE-01 trial, HNSA-5487 demonstrated rapid and highly robust reduction of IgG levels by more than 95 percent within a few hours post treatment. In a 12-month follow up analysis IgG levels returned to normal range six months after initial dosing. This confirms that HNSA-5487 mirrors the extremely high efficacy of imlifidase, the Company's first-generation IgG-cleaving enzyme, in reducing total IgG levels. No serious adverse events were observed and as previously communicated HNSA-5487 is safe and well tolerated.
Importantly, HNSA-5487 demonstrated lower pre-treatment anti-drug antibody (ADA) levels and significantly reduced ADA responses when compared to imlifidase, confirming an attractive immunogenicity profile with a clear redosing potential. HNSA-5487 also demonstrated highly robust reduction in IgG levels with similar efficacy in nearly 100 percent of serum samples collected in the trial and analyzed at six- and 12-months after the initial dose.
Søren Tulstrup, President and CEO, Hansa Biopharma said, "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. We believe HNSA-5487 has a highly differentiated profile compared to published data from studies with other IgG-targeted therapies. These results underscore the transformational potential of HNSA-5487 to address significant unmet need across a spectrum of IgG driven diseases and conditions, including autoimmune where there is a clear need for better management of initial and repeat immune system attacks."
The Company will focus clinical development of HNSA-5487 in chronic autoimmune diseases where IgG plays a role in disease pathology and acute phases. Initial clinical development of HNSA-5487 will focus in myelin oligodendrocyte glycoprotein antibody disease (MOGAD), neuromyelitis optica (NMO) and myasthenia gravis (MG). MOGAD affects 2 – 3.4 in every 100,000 people worldwide and approximately 30 percent of all cases are in children.1 NMO affects approximately seven in every 100,000 people in the US and approximately 22,000 people in the US are living with the condition.2 Globally, approximately 150 to 200 out of every million people have MG.3
These conditions have a common underlying cause: misguided IgG antibodies. Despite the serious nature of these diseases, unmet medical need remains high with few advanced therapies available, and no treatments approved for the acute phases. HNSA-5487 can effectively and quickly reduce IgG levels, potentially addressing a diverse range of debilitating symptoms caused by these conditions.
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. There were no serious adverse events and as previously communicated HNSA-5487 was safe and well tolerated.
About HNSA-5487:
HNSA-5487 is Hansa Biopharma's next-generation IgG-cleaving enzyme with the potential to prolong the IgG-low window. In 2023, Hansa conducted the first-in-human trial of HNSA-5487 (NICE-01) reporting positive high-level results on safety and tolerability and observing complete depletion of IgG antibodies at increasing doses.
NiceR is Hansa Biopharma's next generation IgG-cleaving enzyme program. It is in preclinical development and is designed to enable expansion into a large spectrum of potential indications, including relapsing autoimmune diseases and gene therapy, as well as oncology indications. The lead molecule in the NiceR program is HNSA-5487.
About Hansa Biopharma:
Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. Hansa Biopharma has developed a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa Biopharma has a rich and expanding research and development program based on the Company's proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA.
For more information please visit, www.hansabiopharma.com
