- The detailed examine outcomes confirmed interim findings, displaying secure 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 Part 3 improvement
- IgA Nephropathy (IgAN) is a number one reason for persistent kidney illness with as much as 40% of IgAN sufferers progressing to finish stage kidney illness about 20 years after prognosis
CAMBRIDGE, Mass., Oct. 26, 2024 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: NASDAQ:) “ at this time introduced full outcomes from the Part 2 IGNAZ examine evaluating felzartamab, an investigational anti-CD38 monoclonal antibody, in individuals dwelling 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 entire 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 entire outcomes of the IGNAZ Research 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 dwelling with IgA nephropathy, a number one reason for persistent kidney illness.
The Part 2 IGNAZ examine (n=54) explored the efficacy and security of felzartamab in sufferers with IgAN and excessive danger 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 charge (eGFR), via 24 months. Notably, sufferers maintained a imply discount of roughly 50% within the UPCR via month 24, which was greater than 18 months after the final dose was administered. These outcomes recommend that felzartamab might have the potential to protect kidney perform and be administered on remedy cycles as a substitute 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 might supply upkeep of great immune capabilities important for an infection safety. Total, administration of felzartamab was usually properly tolerated with a security profile in line with prior research.
We’re inspired by the general outcomes of the IGNAZ examine, particularly given the numerous unmet medical want for extra therapies to handle 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 examine employees who contributed to this examine, whose findings will assist us proceed to guage felzartamab’s position in preserving kidney perform as we plan for Part 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 ailments. Felzartamab has been proven in medical research to selectively deplete CD38+ plasma cells, which can enable functions that finally enhance medical outcomes in a broad vary of ailments pushed by pathogenic antibodies. Felzartamab was initially developed by MorphoSys AG for a number of myeloma. Human Immunology Biosciences (HI-Bio) solely licensed the rights to develop and commercialize felzartamab throughout all indications in all international locations and territories excluding China (together with Macau and Hong Kong and Taiwan). Biogen acquired HI-Bio in July 2024.
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 persistent 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 revolutionary science to ship new medicines to rework sufferers’ lives and to create worth for shareholders and our communities. We apply deep understanding of human biology and leverage totally different modalities to advance first-in-class therapies or therapies that ship superior outcomes. Our strategy is to take daring dangers, balanced with return on funding to ship long-term development.
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Biogen Secure Harbor
This information launch incorporates forward-looking statements, together with associated to the potential medical results of felzartamab; the potential advantages, security and efficacy of felzartamab; the medical improvement program for felzartamab; the identification and remedy of IgAN; our analysis and improvement program for the remedy of IgAN; the potential of our business enterprise and pipeline applications, together with felzartamab; and dangers and uncertainties related to drug improvement and commercialization. These forward-looking statements could also be accompanied by phrases corresponding to purpose, anticipate, consider, might, estimate, count on, forecast, intend, might, plan, potential, attainable, will, would and different phrases and phrases of comparable that means. Drug improvement and commercialization contain a excessive diploma of danger, and solely a small variety of analysis and improvement applications lead to commercialization of a product. Ends in early-stage medical trials will not be indicative of full outcomes or outcomes from later stage or bigger scale medical trials and don’t guarantee regulatory approval. You shouldn’t place undue reliance on our forward-looking statements.
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 improvement and potential commercialization of together with felzartamab; the chance that we might not totally enroll our medical trials or enrollment will take longer than anticipated; surprising issues might come up from further knowledge, evaluation or outcomes obtained throughout our medical trials; regulatory authorities might require further data or additional research, or might fail or refuse to approve or might delay approval of our drug candidates, together with felzartamab; the incidence of adversarial security occasions; the dangers of surprising 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 components that might trigger precise outcomes to vary from our expectations in any forward-looking assertion. Buyers ought to think about this cautionary assertion, in addition to the chance components recognized in our most up-to-date annual or quarterly report and in different stories we’ve got filed with the U.S. Securities and Trade Fee. These statements converse solely as of the date of this information launch.
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. Obtainable 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. Obtainable at https://www.kireports.org/article/S2468-0249(17)30362-5/fulltext
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