Hansa Biopharma AB, “announced the acceptance by the U.S. FDA of Hansa’s Investigational New Drug (IND) application to proceed with a Phase 3 study of imlifidase for the treatment of anti-Glomerular Basement Membrane (anti-GBM) disease.
As previously communicated, Hansa held a successful pre-IND meeting with FDA late last year on the study design of its planned Phase 3 study. In parallel, Hansa has also obtained scientific advice from EMA on the corresponding protocol earlier this year with the aim of conducting a global study. The advice from both authorities has been included in the Phase 3 study design.
The pivotal Phase 3 clinical study will enroll 50 patients with anti-GBM disease across the U.S. and Europe and the first patient is expected to be enrolled this year. Patients in this study will be randomised 1:1 to receive either Standard of Care (SoC) or imlifidase plus SoC. The planned primary endpoint of the study is renal function by means of eGFR at six months. Patients will also be evaluated for other parameters related to kidney function during a six-month follow-up period.
The recently completed investigator-initiated Phase 2 study by Professor Mårten Segelmark (GOOD-IDES-01 ClinicalTrials.gov Identifier: NCT03157037) showed that kidney function at 6 months was significantly better than in previously published cohorts, without any safety concerns. Of the 15 patients included, 10 were dependent on dialysis at enrollment. At 6 months, a total of 67% (N=10) of the included patients were dialysis independent, which is significantly better than in the historical control cohort, where only 18% had functioning kidneys. All patients that were dialysis-independent at baseline remained so during the study. This positive outcome has been recognized for its significance, as it suggests that deactivation of autoantibodies by imlifidase could alter the course of an autoimmune disease.
"Acceptance of our IND for this pivotal Phase 3 program in anti-GBM, a devastating disease, is an important milestone that will allow us to begin reaching out to patients soon,” says Christian Kjellman, Chief Scientific Officer at Hansa Biopharma. “Today, most anti-GBM patients suffer terminal damage to their kidneys as their condition progresses. The potential for imlifidase to positively alter the course of the disease is, therefore, very promising and gives hope to these patients, who currently have very few treatment options.”
Imlifidase was granted Orphan Drug Designation in anti-GBM disease by both the FDA and the European Commission in 2018.
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