- WKN: 663200
- ISIN: DE0006632003
- Land: Deutschland
Nachricht vom 20.10.2021 | 22:01
MorphoSys AG: First Patient Dosed in Phase 2 IGNAZ Study of Felzartamab in Patients with Immunoglobulin A Nephropathy
DGAP-News: MorphoSys AG
/ Key word(s): Miscellaneous/Study
First Patient Dosed in Phase 2 IGNAZ Study of Felzartamab in Patients with Immunoglobulin A Nephropathy
MorphoSys AG (FSE: MOR; NASDAQ: MOR) today announced that the first patient has been dosed in the Phase 2 IGNAZ clinical trial evaluating felzartamab for patients with Immunoglobulin A Nephropathy (IgAN). IgAN, also known as Berger's disease, is a chronic and debilitating autoimmune disease affecting the kidneys and the most common glomerular disease worldwide. Currently there are no approved treatments that can specifically prevent the production of galactose-deficient IgA1 (Gd-IgA1) nor its corresponding autoantibody.1
"We believe felzartamab could have great potential as a targeted therapy for patients with autoimmune renal diseases who currently have limited treatment options," said Mikhail Akimov, MD, Senior Vice President and Global Head Drug Development at MorphoSys. "Dosing of the first IgAN patient is an exciting milestone for MorphoSys, physicians and patients alike as we are rapidly broadening our development program for felzartamab."
Felzartamab (MOR202) is an investigational therapeutic human monoclonal antibody derived from MorphoSys' HuCAL(R) antibody library and directed against CD38. By targeting CD38, felzartamab has the potential to deplete the CD38 positive plasma cells, which may ultimately improve the patient's kidney functions. This multi-center, randomized, double-blind, parallel-group, placebo-controlled trial will enroll approximately 48 patients and is designed to assess the efficacy, safety and pharmacokinetic/pharmacodynamic of felzartamab in patients with IgAN (NCT05065970). The primary objective of this study is to evaluate the efficacy of felzartamab compared with placebo. The primary endpoint is relative change in urine protein to creatinine ratio and will be assessed for each patient 9 months after treatment initiation.
Study sites are located in Europe, North America and Asia Pacific, excluding Greater China.
In 2017, MorphoSys entered into an exclusive regional licensing agreement with I-Mab Biopharma (NASDAQ: IMAB) to develop and commercialize Felzartamab in Greater China. I-Mab is currently conducting two parallel registrational trials with felzartamab as a third-line monotherapy and as a second-line combination therapy with lenalidomide, both in patients with multiple myeloma (MM) in Greater China. Felzartamab for MM third-line treatment is on track for BLA submission in Q4 2021 and MM second-line registrational trial is on track for completion of patient enrollment.
Felzartamab is an investigational drug that has not yet been approved by any regulatory authorities.
Monjuvi(R) and HuCAL(R) are registered trademarks of MorphoSys AG.
Tremfya(R) is a registered trademark of Janssen Biotech, Inc.
1 Cheung CK, et al. J Clin Med. 2021;10(11):2493-2512
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|End of News||DGAP News Service|
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