Unlocking New Hope for Patients with ANCA-Associated Vasculitis: First Patient Treated with Imlifidase in Investigator-Initiated Phase 2 Study.

Hansa Biopharma is on the cusp of making history by becoming the first company to initiate an investigator-initiated phase 2 study to treat anti-neutrophil cytoplasmic antibody-associated vasculitis with their revolutionary IgG-cleaving enzyme, imlifidase.

The study has already seen its first patient successfully treated with the groundbreaking enzyme, truly cementing Hansa’s reputation as a pioneer in enzyme technology for rare immunological conditions.

Søren Tulstrup, President and CEO of Hansa Biopharma, has expressed his excitement regarding the development of their platform and pipeline of drug candidates for rare immunological diseases and conditions. Imlifidase acts on areas of high unmet need in the autoimmunity space, with encouraging clinical study results seen in anti-GBM disease and Guillain-Barré syndrome.

With the potential for imlifidase to offer help to even more patients suffering from serious autoimmune diseases and conditions, Hansa Biopharma looks forward to the results of the drug’s latest trial in yet another autoimmune disease.

Dr. Adrian Schreiber and Dr. Philipp Enghard, at Charité Universitätsmedizin, Berlin, Germany are leading a groundbreaking single-center, single-arm, phase 2 trial to evaluate the efficacy and safety of imlifidase in combination with standard of care to treat pulmonary hemorrhage associated with severe ANCA-associated vasculitis. This study is poised to make a major advancement in our understanding of this debilitating condition.

Patients affected by ANCA-associated vasculitis currently have few treatment options to achieve rapid control of disease activity. That is why the Division of Nephrology and Internal Intensive Care Medicine at Charité Universitätsmedizin Berlin is so excited about a promising new therapy: imlifidase.

With its almost immediate and highly effective action, imlifidase has the potential to be an incredibly powerful option for treating this antibody-related disorder, particularly for those with severely active disease. Dr. Philipp Enghard, co-principal investigator of the study, is optimistic that this therapy could revolutionize care for those living with ANCA-associated vasculitis.

We are inviting 10 patients with severe ANCA-associated vasculitis and ARDS due to pulmonary hemorrhage to join our 6-month study to assess the efficacy and safety of imlifidase on top of standard of care.

Results will be monitored through ANCA antibody seroconversion and titers, adverse events, mortality, as well as a detailed evaluation of lung and renal function. Let us together explore the potential of this novel therapy for improving respiratory and renal health.

ANCA-associated vasculitis is an incredibly rare, but serious condition affecting around 30 people in a million in the EU and US annually. Characterized by the presence of IgG anti-neutrophil cytoplasmatic antibodies, ANCA causes the activation of neutrophils, a type of white blood cell, resulting in blood vessel damage and dysfunction of multiple organs, primarily the lungs and kidneys.

This can lead to painful respiratory failure in the most severe cases, and end-stage kidney failure in 25 percent. With any infections or diseases, the importance of seeking professional medical help cannot be underestimated, and ANCA is no exception.

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