ESRD poses a significant global health burden, affecting almost 2.5 million patients worldwide
Chronic kidney disease (CKD) is a progressive disorder indicated by the gradual loss of kidney function over time, with a global prevalence of 9.1%.
As CKD worsens it can progress to kidney failure, also referred to as end-stage renal disease (ESRD) which is the final and most critical stage of CKD where the kidneys can no longer function without support.
People who progress to ESRD will require renal replacement therapy (RRT) which involves either dialysis or kidney transplantation. The number of kidney patients requiring RRT is growing and in Europe there are approximately 63,000 new patients each year. Organ transplantation is a life-saving treatment for patients with ESRD, offering a better quality of life at lower societal cost. Even in end-stage kidney disease, where dialysis as a therapeutic alternative is available on a large scale; transplantation is considered the treatment of choice.
One of the major immunological barriers to transplantation is the presence of preformed antibodies to human leukocyte antigens (HLA)
There are approximately 80,000 kidney patients on transplant waiting lists across the European Union. Currently around 10 to 30% of patients on transplant waiting lists are highly sensitized, they are very unlikely to be offered a transplant, so they spend much longer on waiting lists and have a higher chance of dying whilst waiting for a suitable donor.
Risk factors for developing HLA antibodies include previous transplantation, blood product transfusion and pregnancy, and patients with HLA antibodies are classed as highly sensitized.
Hansa scientists have harnessed an active enzyme found in Streptococcus pyogenes, a bacterium that causes common infections, such as ‘strep throat’ and developed it into Idefirix® (imlifidase), a novel immunoglobulin G-cleaving enzyme therapy that helps patients to receive life-changing kidney transplants.
Through our commitment to research, we have pioneered a unique medical technology that has the potential to treat a wide range of rare immunological conditions.
Idefirix® (imlifidase) is the first and only EMA approved medicine for desensitization of highly sensitized patients prior to deceased donor kidney transplantation, allowing them to be considered for life altering kidney transplantation.
Idefirix® (imlifidase) was reviewed as part of the European Medicines Agency’s (EMA) Priority Medicines (PRIME) scheme, which supports medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options.
Hansa’s research and development program is advancing the company’s technology to develop the next generation of IgG cleaving enzymes, to potentially enable repeat dosing in relapsing autoimmune diseases, chronic transplant rejection, oncology and gene therapy.
Acute Autoimmune Conditions
Imlifidase is currently being evaluated in clinical trials to advance the treatment of Anti-glomerular basement membrane (Anti-GBM) antibody disease or Goodpasture’s disease, Guillain-Barre syndrome and antibody-mediated rejection (AMR) in kidney transplantation.
Antibody-Mediated Graft Rejection
Acute antibody-mediated rejection (AMR) is one of the most challenging adverse events following a kidney transplantation. It occurs in 10-15% of patients and is the main cause for graft dysfunction. There are approximately 80,000 kidney patients on transplant waiting lists across the European Union and approximately 400,000 who currently live with a kidney transplant.
Hansa is conducting a Phase 2 study in AMR, designed to evaluate the safety and efficacy of imlifidase in eliminating donor specific antibodies (DSAs).
Treatment of Goodpasture disease - Anti-GBM antibody disease
Anti-GBM antibody disease, also known as Goodpasture’s disease, is a rare severe kidney disease where the immune system mistakenly develops IgG-antibodies against an antigen intrinsic to the glomerular basement membrane (GBM), resulting in an acute immune attack on the kidneys and in some patients also on the lungs. In severe anti-GBM, the disease may progress to renal failure or death. Less than one third of the patients survive with a preserved kidney function after six months follow-up. Anti-GBM antibody disease is affecting one in a million annually. Imlifidase has been granted Orphan Drug Designation for this indication from FDA and the European Commission. Hansa Biopharma has announced positive high-level data from an investigator-initiated phase 2 trial with imlifidase to treat anti-GBM disease. The study concluded that imlifidase leads to rapid clearance of anti-GBM antibodies, with two-thirds of patients achieving dialysis independence six months after treatment.
Guillain-Barré Syndrome (GBS) is a rare, acute, paralyzing disease of the peripheral nervous system, affecting 1-2 in 100,000 people per year. GBS is usually preceded by an infection or other immune stimulation that induces an autoimmune response, targeting the peripheral nervous system. It is the most frequent cause of acute neuromuscular weakness in the Western world and can occur at any age. Mortality rate is 3-7 %. GBS is a rapidly progressive monophasic disorder, often leading to a severe paralysis of the arms and legs. Most GBS patients have sensory disturbances (tingling, numbness or ataxia) and pain, and some patients have double vision or problems with swallowing. GBS may also paralyze the respiratory muscles, leading to intensive care unit admission and mechanical ventilation. Current standard of care is either IVIg or plasmapheresis. There is a significant need for better treatment options. Imlifidase has been granted Orphan Drug Designation for this indication from FDA and the European Commission. An Investigator Initiated Phase 2 clinical trial with imlifidase led by Professor Mårten Segelmark from the universities in Linköping and Lund, is currently conducted to evaluate the safety, tolerability and efficacy of imlifidase in GBS patients in combination with standard immunoglobulin care.
Hansa Biopharma is a rare disease company, delivering and developing innovative, lifesaving and life-changing treatments for patients with rare immunological conditions.
The European Union considers a disease as rare when it affects less than 1 in 2,000 people. Rare diseases currently affect 3.5% - 5.9% of the worldwide population, an estimated 30 million people in Europe and 300 million worldwide.