Hansa Biopharma has dosed the first patient in a pivotal Phase III trial investigating imlifidase in patients with anti-glomerular basement membrane (anti-GBM) disease. The Sweden-based company claims that the global trial is the first and currently only randomised trial in anti-GBM disease.
Anti-GBM disease, also known as Goodpasture disease, is a rare and severe autoimmune condition characterised by the immune system mistakenly developing antibodies that attack the kidneys and lungs.
Imlifidase is an immunosuppressive agent that neutralises IgG antibodies. In 2020, the drug was marketed as Idefirix for kidney transplant rejection in Europe and Israel.
The open-label Phase III trial (NCT05679401) will enrol 50 patients with severe anti-GBM disease. The global study will open 30-40 sites across the US, UK, and EU. Patients will be randomised in a 1:1 ratio to either imlifidase and standard of care (SoC) cohort or SoC only arm, consisting of a combination of immunosuppressives, glucocorticoids, and plasma exchange.
The trial’s primary endpoint will measure renal function, which is evaluated by the estimated glomerular filtration rate (eGFR) at six months and the need for dialysis. Secondary measures will evaluate other renal-related outcomes, as well as the safety profile and efficacy in pulmonary symptoms and health-related quality of life aspects.
Hansa first announced its plans to start the Phase III trial in anti-GBM disease in 2021, after a pre-investigational new drug (IND) meeting with the US Food and Drug Administration (FDA).
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Phase II trial data
Imlifidase was evaluated in an investigator-led Phase II trial in patients with anti-GBM disease who are receiving SoC consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide combined with plasma exchange.
The open-label trial (NCT03157037) recruited 15 participants and measured the number of patients with independent renal function at six months as the trial’s primary endpoint.
In March 2022, Hansa announced that two-thirds of patients achieved dialysis independence after the treatment compared to 18% of patients in a historical control cohort. The Phase II trial was sponsored by Mårten Segelmark, professor of nephrology at Linköping University.
Imlifidase in rare diseases
In April, Hansa released updates on two trials that investigate imlifidase in other rare diseases. At the beginning of the month, the company closed enrolment in a Phase II trial investigating the drug in Guillain-Barré Syndrome (GBS), a rare inflammatory disease of the peripheral nervous system. Topline results are expected in H2 2023.
Hansa also announced a collaboration with France-based non-profit biotherapy company Genethon to test imlifidase as a pre-treatment for Genethon’s gene therapy GNT-0003 in patients with the ultra-rare disease Crigler-Najjar syndrome.