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CAMBRIDGE, Mass., Oct. 26, 2024 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) — today presented full results from the Phase 2 IGNAZ study evaluating felzartamab, an anti-CD38 monoclonal antibody, in people with kidney disease by IgA. (IgAN). The results showed a significant reduction in proteinuria, stabilization of renal function, and a sustained treatment effect for more than 18 months after the last dose of fulsartamab. The full results were shared during an oral presentation at Kidney Week 2024, the annual meeting of the American Society of Nephrology, in San Diego, California.
“The full results of the IGNAZ study provisionally confirm our findings, showing a reduction in proteinuria, stabilization of renal function and an effect of continuing treatment for 18 months after the last dose of filzartamab,” said Jonathan Barratt. , MD, PhD, FRCP. Mayer is Professor of Nephrology at the University of Leicester. “This is promising news for patients and supports the potential of filzartamab as a useful treatment option for people with IgA nephropathy, the leading cause of chronic kidney disease.”
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The phase 2 IGNAZ study (n=54) explored the efficacy and safety of filzartamab in patients with IgAN and high risk of progressive renal dysfunction. In terms of efficacy, patients receiving a nine-dose regimen of filsartamab over a six-month treatment period experienced a significant reduction in proteinuria levels as assessed by urinary protein:creatinine ratio (UPR) and stabilization of function. kidney, measured by the estimated rate. . Glomerular filtration rate (eGFR) at 24 months. Of note, patients maintained an average reduction of approximately 50% in UPCR through month 24, more than 18 months after the last dose. These results suggest that filzartamab may have the potential to preserve renal function and is administered in cycles rather than continuous doses.
Further analysis revealed that filzartamab administration produced selective and long-lasting reductions in IgA antibody levels, while IgG and IgM levels recovered to baseline after 3 months of treatment. This selective reduction may preserve important immune functions essential for protection against infections. Overall, filzartamab was well tolerated with a safety profile consistent with previous studies.
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“We are encouraged by the overall results of the IGNAZ study, especially given the significant unmet medical need for additional therapies to treat high-risk IgA nephropathy,” said Aptal Patel, MD, director of HI-Bio development at Biogen. “We thank all study participants, investigators, and staff who contributed to this study and whose results will help us continue to evaluate the role of feldsartumab in preserving kidney function as we plan for Phase III.”
About feldsartamab
Felzartamab is a therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Filzartamab is a potential first-in-class therapeutic candidate with a pipeline for a variety of immune-mediated diseases. Fulzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may enable applications that ultimately improve clinical outcomes in a wide range of diseases caused by pathogenic autoantibodies. Felzartamab was originally developed by MorphoSys AG to treat multiple myeloma. Human Immunology Biosciences (HI-Bio) has exclusively licensed the rights to develop and commercialize filzartamab in all indications in all countries and territories except China (including Macau, Hong Kong and Taiwan). Biogen acquired HI-Bio in July 2024.
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Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory body and its safety and efficacy have not been established.
About IgA Nephropathy (IgAN)
Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis worldwide. It is a major cause of chronic kidney disease and up to 40% of patients with IgAN progress to end-stage kidney disease approximately 20 years after diagnosis. IgAN accounts for approximately 40% of all local renal biopsies in Japan, 25% in Europe, and 12% in the United States, but less than 5% in Central Africa.1
About Biogen
Founded in 1978, Biogen is a pioneering biotechnology company that advances innovative science to deliver new medicines that transform patients' lives and create value for shareholders and our communities. We apply a deep understanding of human biology and leverage different modalities to develop world-class treatments or cures that deliver superior results. Our approach is to take bold risks, balancing them with return on investment to achieve long-term growth.
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Biojin Safe Harbor
This press release contains forward-looking statements, including with respect to the possible clinical effects of filzartamab; Potential benefits, safety and efficacy of filzartamab; The clinical development program of the drug “Felzartamab”; Identification and treatment of IgAN; Our research and development program for the treatment of IgAN; the potential of our commercial businesses and pipeline programs, including feldsartamab; and the risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as “aim,” “expect,” “believe,” “could,” “estimate,” “anticipate,” “expect,” “intend,” “could,” “plan.” “, “”Possible”, “possible”, “would”, “would be” and other words and terms with similar meanings. The development and commercialization of medicines involves a high degree of risk and only a few R&D programs lead to the commercialization of a product. Results from early-stage clinical trials may not be indicative of full results or the results of later-stage or large-scale clinical trials and do not guarantee regulatory approval. You should not place undue reliance on our forward-looking statements.
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These statements involve risks and uncertainties that could cause actual results to differ materially from those in such statements, including, but not limited to, the uncertainty of successful development and potential commercialization, including feldsartumab; the risk that our clinical trials are not fully registered or that registration takes longer than expected; Unforeseen concerns may arise from additional data, analyzes or results obtained during our clinical trials; Regulatory authorities may require additional information or additional studies, or may reject, deny approval or delay approval of our drug candidates, including filzartamab; Occurrence of adverse safety events; the risk of unexpected obstacles, costs or delays; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties regarding intellectual property claims and challenges; product liability claims; Results of operations and financial condition. The foregoing describes many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statements. Investors should consider this cautionary statement in addition to the risk factors identified in our most recent annual or quarterly report and other reports we have filed with the SEC. These statements speak only as of the date of this press release.
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We undertake no obligation to publicly update any forward-looking statements.
References:
- Rajasekaran et al. (2021) IgA nephropathy: an interesting autoimmune kidney disease. Available from Hastings et al (2018) Clinical Research, Life Expectancy of Southeastern United States Patients with IgA Nephropathy. Available at https://www.kireports.org/article/S2468-0249(17)30362-5/fulltext
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