Soren Tulstrup, President and CEO,
GOOD-IDES-02 is an open label, multi-center, phase 3 trial of 50 patients. A total of 30-40 centers are expected to be included in the study across the US,
The study follows a completed investigator-initiated phase 2 trial, which concluded that imlifidase therapy leads to rapid clearance of anti-GBM antibodies, with two-thirds of patients achieving dialysis independence six months after treatment compared to 18% in a historical control cohort.1
Marten Segelmark, International Coordinating Investigator and Professor of Nephrology at
Anti-glomerular basement membrane (anti-GBM) disease, also known as Goodpasture disease, is a rare, severe autoimmune condition affecting around 1.6 people per million annually with majority of patients losing their kidney function.2,3 In anti-GBM disease, the immune system mistakenly develops antibodies against an antigen intrinsic to the glomerular basement membrane, resulting in an acute immune attack of the kidneys and, in around half of the patients, also the lungs. Approximately two thirds of anti-GBM patients will experience kidney failure and require long-term dialysis while awaiting potential kidney transplantation.4 Some patients may also experience bleeding from the lungs. In one out of six patients, anti-GBM disease can become fatal during the acute phase.
Imlifidase has been granted orphan drug designation for the treatment of anti-GBM disease by both the
Contact:
Tel: +46 (0) 709-298 269
Email: klaus.sindahl@hansabiopharma.com
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