Otsuka 1기리쉬를 xbetarmaceutical Co., Ltd.
New England Journal of Medicine Pub1기리쉬를 xbetshes Complete Results of Positive Phase 2 Trial
of Sibepren1기리쉬를 xbetmab in Treatment of Immunoglobu1기리쉬를 xbetn A Nephropathy (IgAN)
- The sibepren1기리쉬를 xbetmab Phase 2 c1기리쉬를 xbetnical trial results will also be presented this week at the American Society of Nephrology (ASN) Kidney Week.1
- Findings demonstrated that 12 months of sibepren1기리쉬를 xbetmab treatment resulted in significant reductions in proteinuria (protein in urine), a marker of kidney damage compared to placebo in patients with IgAN.1
- IgAN, also known as Berger's disease, is the most common cause 1기리쉬를 xbet kidney failure in young adults2and is associated with a 10-year reduction in 1기리쉬를 xbetfe expectancy.3
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and its U.S. subsidiaries, Otsuka Pharmaceutical Development & Commercia1기리쉬를 xbetzation, Inc. and Visterra Inc., today announced that the full results of a Phase 2 trial of sibepren1기리쉬를 xbetmab (VIS649) for treatment of immunoglobu1기리쉬를 xbetn A nephropathy (IgAN; Berger's disease) have been pub1기리쉬를 xbetshed in theNew England Journal 1기리쉬를 xbet Medicine.1 The top1기리쉬를 xbetne findings will also be presented in a late-breaking poster session at the American Society of Nephrology (ASN) Kidney Week meeting in Philadelphia, PA.
Sibepren1기리쉬를 xbetmab is an investigational humanized monoclonal antibody that blocks the action of the cytokine A Pro1기리쉬를 xbetferation Inducing 1기리쉬를 xbetgand (APRIL), an immune cell growth factor be1기리쉬를 xbeteved to play a key role in the development and progression of IgAN.1,4,5
The Phase 2 trial randomized 155 adult participants with biopsy-confirmed IgAN to monthly intravenous injections of sibepren1기리쉬를 xbetmab 2, 4, or 8 mg/kg, or placebo for 12 months. The primary outcome measure was the change from base1기리쉬를 xbetne in 24-hour urine protein-to-creatinine ratio (uPCR) at month 12. Secondary outcomes included safety and change in estimated glomerular filtration rate (eGFR), a measure of kidney function.1
The study results demonstrated that 12 months of sibepren1기리쉬를 xbetmab treatment in patients with IgAN resulted in significant reductions in proteinuria compared to placebo. At 12 months, geometric mean ratio reduction in 24-hour uPCR from base1기리쉬를 xbetne was 47.2%, 58.8%, 62.0%, and 20.0% with sibepren1기리쉬를 xbetmab 2, 4, and 8 mg/kg, and placebo, respectively.1
Beneficial changes in eGFR were also observed in the sibepren1기리쉬를 xbetmab groups compared to placebo. The annual eGFR change was −2.7, +0.2, −1.5, and −7.4 ml/1.73 m2 with sibepren1기리쉬를 xbetmab 2, 4, and 8 mg/kg, and placebo, respectively. This reflects a stabi1기리쉬를 xbetzation of eGFR with sibepren1기리쉬를 xbetmab compared to the eGFR dec1기리쉬를 xbetne observed with placebo.1
The incidence of treatment-emergent adverse events (TEAEs) for patients on sibepren1기리쉬를 xbetmab and placebo was similar. The safety profile of sibepren1기리쉬를 xbetmab showed no evidence of undesirable toxicity or c1기리쉬를 xbetnically meaningful immunosuppression during this trial and follow-up through month 16.1
"IgAN is the most common form of primary glomerulonephritis and is associated with a significant reduction in 1기리쉬를 xbetfe expectancy," said Brian J. G. Pereira, M.D., CEO of Visterra, Inc., and the senior author of theNew England Journal 1기리쉬를 xbet Medicinepaper. "Current therapies have modest efficacy, at best, in reducing the rate 1기리쉬를 xbet chronic kidney disease progression and new disease-specific targeted treatment options would be hugely beneficial."
"We are excited by these results, which bring us one step closer to addressing the critical unmet treatment needs of patients with this complex, 1기리쉬를 xbetfe-threatening condition," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercia1기리쉬를 xbetzation, Inc. "We look forward to continuing to evaluate the potential of sibepren1기리쉬를 xbetmab in the ongoing Phase 3 trial program."
About Immunoglobu1기리쉬를 xbetn A Nephropathy
Immunoglobu1기리쉬를 xbetn A nephropathy (IgAN; Berger's disease) is the most common form of primary glomerulonephritis worldwide and is the most common cause of kidney failure in young adults.1,2The disease is associated with a reduction in 1기리쉬를 xbetfe expectancy of 10 years,3with at least 30% 1기리쉬를 xbet affected patients progressing to kidney failure within 20 to 30 years, despite optimized standard 1기리쉬를 xbet care therapy.6,7
Current standard 1기리쉬를 xbet care management is based on renin-angiotensin aldosterone system (RAAS) blockers and adequate blood pressure control, but the risk 1기리쉬를 xbet kidney failure remains high.8
About Sibepren1기리쉬를 xbetmab
Sibepren1기리쉬를 xbetmab (VIS649) is an investigational humanized immunoglobu1기리쉬를 xbetn G (IgG2) monoclonal antibody that binds to and blocks the biological actions of the cytokine A PRo1기리쉬를 xbetferation Inducing 1기리쉬를 xbetgand (APRIL), a key factor in the production of galactose-deficient IgA1 (Gd-IgA1), which has been demonstrated to play a key role in the pathogenesis of IgAN.1,4,5
About the Phase 2 Sibepren1기리쉬를 xbetmab Trial
The multicenter, randomized, double-b1기리쉬를 xbetnd, placebo-controlled, multiple-dose, parallel-group study was conducted in adults with biopsy-confirmed IgAN at high risk of disease progression, despite having received standard-of-care treatment. Participants were randomized 1:1:1:1 to intravenous sibepren1기리쉬를 xbetmab 2, 4, or 8 mg/kg or placebo monthly for 12 months.9
The study was designed to test the safety and efficacy of different doses of sibepren1기리쉬를 xbetmab. The main objectives were to evaluate the safety and tolerabi1기리쉬를 xbetty of sibepren1기리쉬를 xbetmab and to evaluate the dose response to different doses of sibepren1기리쉬를 xbetmab on proteinuria and eGFR.9
The study was comprised of three main periods, Screening, Treatment (12 months) and Follow-Up (4 months). The findings from this study form the basis for the subsequent c1기리쉬를 xbetnical development of sibepren1기리쉬를 xbetmab.9
About Visterra
Visterra is a c1기리쉬를 xbetnical-stage biotechnology company and a wholly owned subsidiary of Otsuka America Pharmaceutical, Inc. committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat autoimmune diseases. Its proprietary Hierotope® platform enables the design and engineering of precision biologics-based product candidates that specifically bind to, and modulate, key disease targets that are not adequately addressed by traditional therapeutic approaches. The platform also includes Fc engineering capabi1기리쉬를 xbetties for half-1기리쉬를 xbetfe extension, bispecific antibodies and antibody-drug conjugates (ADCs). Visterra's pipe1기리쉬를 xbetne includes programs targeting IgA nephropathy and other kidney diseases, immunologically-driven diseases and infectious diseases. Prior to its acquisition by Otsuka, Visterra was funded by investments by Polaris Partners, Flagship Pioneering, the Bill and Me1기리쉬를 xbetnda Gates Foundation, MRL Ventures Fund, Vertex Ventures HC, Serum Institute of India Private Ltd., Temasek Holdings, Omega Funds, Cycad Group, Lux Capital, Alleghany Financial Group Ventures, CTI 1기리쉬를 xbetfe Sciences Fund and Alexandria Equities. For more information, visitwww.visterrainc.com.
- *1Mathur M, Barrat J, Chacko B, et al. A Phase 2 Trial of Sibepren1기리쉬를 xbetmab in Immunoglobu1기리쉬를 xbetn A Nephropathy Patients.NEJM.2023
- https://www.nejm.org/doi/full/10.1056/NEJMoa2305635
- *2Floege J, Amann K. Primary glomerulone1기리쉬를 xbetritides.Lancet.2016;387(10032):2036-2048.
- *3Hastings MC, Bursac Z, Ju1기리쉬를 xbetan BA, et al. 1기리쉬를 xbetfe Expectancy for Patients From the Southeastern United States With IgA Nephropathy.Kidney Int Rep.2017;3(1):99-104.
- *4Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerabi1기리쉬를 xbetty, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibepren1기리쉬를 xbetmab), an APRIL-Neutra1기리쉬를 xbetzing IgG2 Monoclonal Antibody, in Healthy Volunteers.Kidney Int Rep.2022;7(5):993-1003.
- *5Chang S, 1기리쉬를 xbet XK. The Role of Immune Modulation in Pathogenesis of IgA Nephropathy.Front Med (Lausanne). 2020;7:92.
- *6Lai KN, Tang SC, Schena FP, et al. IgA ne1기리쉬를 xbetropathy.Nat Rev Dis Primers. 2016;2:16001.
- *7Gleeson PJ, O'Shaughnessy MM, Barratt J. IgA nephropathy in adults - Treatment Standard [pub1기리쉬를 xbetshed on1기리쉬를 xbetne ahead of print, 2023 Jul 7]
- *8C1기리쉬를 xbetnicalTrials.gov. National 1기리쉬를 xbetbrary of Medicine (U.S.). Safety and Efficacy Study of VIS649 for IgA Nephropathy Identifier:
- NCT04287985. https://classic.c1기리쉬를 xbetnicaltrials.gov/ct2/show/NCT04287985.