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Printed Oct 26, 2024 • 6 minute learn
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- The detailed research outcomes confirmed interim findings, displaying steady kidney perform and sustained remedy impact greater than 18 months after the final dose of felzartamab
- Felzartamab, an investigational anti-CD38 monoclonal antibody, is a possible first-in-class therapeutic candidate for a spread of uncommon immune-mediated indications with planning underway for Section 3 growth
- IgA Nephropathy (IgAN) is a number one reason for continual kidney illness with as much as 40% of IgAN sufferers progressing to finish stage kidney illness about 20 years after prognosis
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CAMBRIDGE, Mass., Oct. 26, 2024 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) – as we speak offered full outcomes from the Section 2 IGNAZ research evaluating felzartamab, an investigational anti-CD38 monoclonal antibody, in individuals residing with IgA nephropathy (IgAN). The outcomes confirmed substantial reductions in proteinuria, stabilization of kidney perform, and sustained remedy impact greater than 18 months after the final dose of felzartamab. The whole outcomes have been shared throughout an oral presentation at Kidney Week 2024, the American Society of Nephrology’s annual assembly, in San Diego, California.
“The whole outcomes of the IGNAZ Examine reaffirm our interim findings, displaying a discount in proteinuria, stabilization of kidney perform, and sustained remedy impact greater than 18 months after the final dose of felzartamab,” mentioned Jonathan Barratt, MD, PhD, FRCP, Mayer Professor of Renal Drugs on the College of Leicester. “That is promising information for sufferers and helps the potential of felzartamab to be a significant remedy choice for individuals residing with IgA nephropathy, a number one reason for continual kidney illness.”
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The Section 2 IGNAZ research (n=54) explored the efficacy and security of felzartamab in sufferers with IgAN and excessive threat of progressive kidney dysfunction. With respect to efficacy, sufferers receiving a nine-dose routine of felzartamab over a six-month remedy interval skilled substantial reductions in proteinuria ranges as assessed by the urinary protein:creatinine ratio (UPCR) and stabilization of kidney perform, as measured by the estimated glomerular filtration price (eGFR), by way of 24 months. Notably, sufferers maintained a imply discount of roughly 50% within the UPCR by way of month 24, which was greater than 18 months after the final dose was administered. These outcomes counsel that felzartamab could have the potential to protect kidney perform and be administered on remedy cycles as an alternative of steady dosing.
Additional evaluation revealed that felzartamab administration resulted in selective and sturdy reductions in IgA antibody ranges, whereas IgG and IgM ranges recovered to baseline 3 months off-treatment. This selective discount could provide upkeep of great immune capabilities important for an infection safety. General, administration of felzartamab was usually properly tolerated with a security profile in step with prior research.
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“We’re inspired by the general outcomes of the IGNAZ research, particularly given the numerous unmet medical want for added remedies to deal with high-risk IgA nephropathy,” mentioned Uptal Patel, M.D., Head of Growth, HI-Bio at Biogen. “We’re grateful to all of the contributors, investigators and research employees who contributed to this research, whose findings will assist us proceed to judge felzartamab’s function in preserving kidney perform as we plan for Section 3.”
About Felzartamab
Felzartamab is an investigational therapeutic human monoclonal antibody directed towards CD38, a protein expressed on mature plasma cells. Felzartamab is a possible first-in-class therapeutic candidate with promise as a pipeline-in-a-product throughout a spread of immune-mediated illnesses. Felzartamab has been proven in scientific research to selectively deplete CD38+ plasma cells, which can enable purposes that in the end enhance scientific outcomes in a broad vary of illnesses pushed by pathogenic antibodies. Felzartamab was initially developed by MorphoSys AG for a number of myeloma. Human Immunology Biosciences (HI-Bio) completely licensed the rights to develop and commercialize felzartamab throughout all indications in all nations and territories excluding China (together with Macau and Hong Kong and Taiwan). Biogen acquired HI-Bio in July 2024.
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Felzartamab is an investigational therapeutic candidate that has not but been accepted by any regulatory authority and its security and effectiveness haven’t been established.
About IgA Nephropathy (IgAN)
Immunoglobulin A nephropathy (IgAN) is the commonest main glomerulonephritis worldwide. It’s a main reason for continual kidney illness with as much as 40% of IgAN sufferers progressing to finish stage kidney illness about 20 years after prognosis. IgAN accounts for about 40% of all native-kidney biopsies in Japan, 25% in Europe, 12% in the US, however lower than 5% in central Africa.1
About Biogen
Based in 1978, Biogen is a number one biotechnology firm that pioneers modern science to ship new medicines to remodel sufferers’ lives and to create worth for shareholders and our communities. We apply deep understanding of human biology and leverage completely different modalities to advance first-in-class remedies or therapies that ship superior outcomes. Our strategy is to take daring dangers, balanced with return on funding to ship long-term progress.
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We routinely put up data that could be essential to buyers on our web site at www.biogen.com. Observe us on social media – Fb, LinkedIn, X, YouTube.
Biogen Protected Harbor
This information launch incorporates forward-looking statements, together with associated to the potential scientific results of felzartamab; the potential advantages, security and efficacy of felzartamab; the scientific growth program for felzartamab; the identification and remedy of IgAN; our analysis and growth program for the remedy of IgAN; the potential of our industrial enterprise and pipeline packages, together with felzartamab; and dangers and uncertainties related to drug growth and commercialization. These forward-looking statements could also be accompanied by phrases akin to “purpose,” “anticipate,” “consider,” “might,” “estimate,” “count on,” “forecast,” “intend,” “could,” “plan,” “potential,” “doable,” “will,” “would” and different phrases and phrases of comparable which means. Drug growth and commercialization contain a excessive diploma of threat, and solely a small variety of analysis and growth packages lead to commercialization of a product. Leads to early-stage scientific trials might not be indicative of full outcomes or outcomes from later stage or bigger scale scientific trials and don’t guarantee regulatory approval. You shouldn’t place undue reliance on our forward-looking statements.
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These statements contain dangers and uncertainties that might trigger precise outcomes to vary materially from these mirrored in such statements, together with with out limitation, uncertainty of success within the growth and potential commercialization of together with felzartamab; the danger that we could not absolutely enroll our scientific trials or enrollment will take longer than anticipated; sudden considerations could come up from extra knowledge, evaluation or outcomes obtained throughout our scientific trials; regulatory authorities could require extra data or additional research, or could fail or refuse to approve or could delay approval of our drug candidates, together with felzartamab; the incidence of adversarial security occasions; the dangers of sudden hurdles, prices or delays; failure to guard and implement our knowledge, mental property and different proprietary rights and uncertainties regarding mental property claims and challenges; product legal responsibility claims; outcomes of operations and monetary situation. The foregoing units forth many, however not all, of the elements that might trigger precise outcomes to vary from our expectations in any forward-looking assertion. Traders ought to take into account this cautionary assertion, in addition to the danger elements recognized in our most up-to-date annual or quarterly report and in different stories now we have filed with the U.S. Securities and Trade Fee. These statements communicate solely as of the date of this information launch.
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We don’t undertake any obligation to publicly replace any forward-looking statements.
References:
- Rajasekaran et al. (2021) IgA nephropathy: An attention-grabbing autoimmune kidney illness. Accessible at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5198292/. Hastings et al (2018) Medical Analysis, Life Expectancy for Sufferers From the Southeastern United States With IgA Nephropathy. Accessible at https://www.kireports.org/article/S2468-0249(17)30362-5/fulltext
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