Biogen Presents Positive Results from Phase 2 IGNAZ Study of Felzartamab in IgA Nephropathy at American Society of Nephrology (ASN) Kidney Week 2024

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• Detailed study results confirmed the interim results, showing stabilization of kidney function and a sustained treatment effect over 18 months after the last dose of fulzartamab.
• Felzartamab, an anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a group of rare immune indications with phase III development underway.
• IgAN nephropathy (IgAN) is a major cause of chronic kidney disease with up to 40% of IgAN patients progressing to end-stage kidney disease approximately 20 years after diagnosis.

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Cambridge, Massachusetts, October 26, 2024 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) – Today it presented complete results from the phase 2 IGNAZ study evaluating felzartamab, an anti-CD38 monoclonal antibody, in people with IgA nephropathy (IgAN). The results showed a significant reduction in proteinuria, stabilization of kidney 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 confirm our findings provisionally, showing a reduction in proteinuria, stabilization of kidney function, and an effect of continued treatment over 18 months after the last dose of fulsartamab,” 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 to be 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. Regarding 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 the urinary protein:creatinine ratio (UPR) and stabilization of renal function, as measured by the rate Estimated. Glomerular filtration rate (eGFR) at 24 months. It is noteworthy that patients maintained an average reduction of about 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 kidney function and is given in cycles rather than continuous doses.

Further analysis revealed that administration of filzartamab resulted in selective and durable reductions in IgA antibody levels, while IgG and IgM levels recovered to baseline after 3 months of treatment. This selective reduction may provide preservation of important immune functions essential for protection against infection. Overall, filzartamab was generally 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, chief development officer of HI-Bio at Biogen. “We are grateful to all the participants, investigators, and study 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 phase III.”

About feldsartamab
Felzartamab is a therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Filsartamab is a potential first-in-class therapeutic candidate and is a pipeline product across a range of immune-mediated diseases. Fulzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow for 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 across 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 proven.

About IgA Nephropathy (IgAN)
Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis worldwide. It is a major cause of chronic kidney disease with up to 40% of IgAN patients progressing to end-stage kidney disease approximately 20 years after diagnosis. IgAN accounts for approximately 40% of all local kidney 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 pioneers innovative science to deliver new medicines to 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 first-in-class treatments or cures that deliver superior results. Our approach is to take bold risks, balancing them with return on investment for long-term growth.

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We routinely post information that may be important to investors on our website www.biogen.com. Follow us on social media – Facebook, LinkedIn, X, YouTube.

Biojin Safe Harbor
This press release contains forward-looking statements, including with respect to the potential clinical effects of filzartamab; Potential benefits, safety, and efficacy of filzartamab; Felzartamab clinical development program; 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 felzartamab; and the risks and uncertainties associated with drug development and marketing. These forward-looking statements may be accompanied by words such as “aim”, “expect”, “believe”, “could”, “estimate”, “expect”, “anticipate”, “intend”, “may”, “plan”, “Possible”, “possible”, “will”, “will” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a few R&D programs lead to the commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from 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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Such statements involve risks and uncertainties that could cause actual results to differ materially from those in such statements, including, without limitation, the uncertainty of successful development and potential commercialization including fulsartamab; the risk that our clinical trials may not be fully registered or that registration will take longer than expected; Unanticipated concerns may arise from additional data, analyzes or results obtained during our clinical trials; Regulatory authorities may require additional information or further studies, or may fail, deny approval or may 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, factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, in addition to the risk factors identified in our most recent annual or quarterly report and in 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:

1. Rajasekaran et al. (2021) IgA nephropathy: an interesting autoimmune kidney disease. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5198292/. Hastings et al (2018) Clinical research, life expectancy of patients from the southeastern United States with IgA nephropathy. Available at https://www.kireports.org/article/S2468-0249(17)30362-5/fulltext

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