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Vera Therapeutics Partners With University of Michigan on the NEPTUNE Match Project and PIONEER Study

Vera Therapeutics Partners With University of Michigan on the NEPTUNE Match Project and PIONEER Study

Vera Therapeutics與密歇根大學合作NEPTUNE Match項目和PIONEER研究。
GlobeNewswire ·  11/11 08:00
  • Participants with nephrotic syndrome in NEPTUNE Match will receive information about the PIONEER study and other clinical trials based on their individual disease characteristics;
  • PIONEER study expands the investigation of atacicept into multiple autoimmune glomerular diseases, supported by the disease-modifying potential of BAFF/APRIL dual inhibition;
  • NEPTUNE Match中患有腎病綜合徵的參與者將根據其個體疾病特徵收到有關PIONEER研究和其他臨床試驗的信息;
  • PIONEER研究擴展了對atacicept在多種自身免疫性腎小球疾病中的研究,受到BAFF/APRIL雙抑制疾病修飾潛力的支持;

BRISBANE, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, is partnering with the University of Michigan on the Nephrotic Syndrome Study Network (NEPTUNE) Match project.

加州布里斯班,2024年11月11日(全球新聞社)-- Vera Therapeutics, Inc.(納斯達克:VERA)是一家專注於爲嚴重免疫性疾病患者開發和商業化變革性治療方案的生物技術公司,正在與密歇根大學合作進行腎病綜合徵研究網絡(NEPTUNE)Match項目。

NEPTUNE is a multicenter consortium of more than 30 North American academic centers that conducts clinical and translational research on kidney diseases that present as nephrotic syndrome (NS), including primary membranous nephropathy (pMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD). Through NEPTUNE Match, participants and their nephrologists receive information about clinical trials targeting mechanisms that match the participant's molecular disease characteristics. This evidence-based approach to selecting clinical trials is aimed at improving treatment response and more successful outcomes across trials.

NEPTUNE是一個由30多家北美學術中心組成的多中心質優聯盟,致力於對錶現爲腎病綜合徵(NS)的腎臟疾病進行臨床和轉化研究,包括原發性膜性腎病(pMN)、局竈節段性腎小球硬化(FSGS)和微小病變病(MCD)。通過NEPTUNE Match,參與者及其腎病專家將收到關於針對與參與者分子病變特徵匹配的機制的臨床試驗的信息。這種基於證據的選擇臨床試驗的方法旨在改善治療反應並提高跨試驗的更成功結局。

In partnership with Vera Therapeutics, NEPTUNE Match will inform potential participants about the PIONEER study. PIONEER represents the expansion of the atacicept development program into multiple autoimmune kidney indications based on the presence of antibodies to glomerular antigens. In addition to a broader population of IgAN, the PIONEER study will evaluate the efficacy and safety of atacicept in anti-PLA2R podocytopathies (pMN) and anti-nephrin podocytopathies (FSGS and MCD). NEPTUNE Match will help participants with anti-PLA2R and anti-nephrin antibodies learn about the PIONEER study and support an informed decision about clinical trial participation.
"Based on the positive long-term data from the ORIGIN Phase 2b study presented at ASN Kidney Week, we're excited to offer a clinical trial with atacicept to patients with nephrotic syndrome who have biomarkers that may predict a positive response to B cell modulation," said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. "In addition to providing patients with crucial resources and education about their individual disease biology, NEPTUNE Match will support the enrollment of eligible participants for the PIONEER study. We look forward to announcing initial data from PIONEER in 2025."

與Vera Therapeutics合作,NEPTUNE Match將向潛在參與者介紹PIONEER研究。PIONEER代表了將atacicept開發計劃擴展到多種自身免疫性腎臟適應症的行動,基於對腎小球抗原抗體的存在。除了更廣泛的IgAN人群外,PIONEER研究還將評估atacicept在抗PLA2R腎小球病(pMN)和抗nephrin腎小球病(FSGS和MCD)中的療效和安全性。NEPTUNE Match將幫助具有抗PLA2R和抗nephrin抗體的參與者了解PIONEER研究,並支持對臨床試驗參與做出明智決定。
根據在ASN腎臟周提出的ORIGIN第20億研究的積極長期數據,我們很高興地宣佈向那些具有可能預測對b細胞調節產生積極反應的腎病綜合徵患者提供atacicept的臨床試驗," Vera Therapeutics的創始人兼首席執行官Marshall Fordyce表示。"除了爲患者提供關於其個體疾病生物學的關鍵資源和教育外,NEPTUNE Match還將支持符合條件的參與者加入PIONEER研究。我們期待在2025年公佈PIONEER研究的初步數據。

"We are thrilled to partner with Vera Therapeutics in NEPTUNE Match. With the new, disruptive insights into pathobiology of NS gleaned in NEPTUNE, we can now target specific antibody-mediated glomerular damage. Testing the efficacy of atacicept among patients identified with active, antibody-mediated disease will truly bring the latest science meaningfully back to our study participants and patients who are in urgent need of new therapies," stated Matthias Kretzler, M.D., Warner Lambert-Parke Davis Professor of Medicine, University of Michigan and principal investigator of NEPTUNE.
About NEPTUNE
The Nephrotic Syndrome Study Network (NEPTUNE) is a multi-site collaborative study that conducts clinical and translational research on FSGS, MCD, and MN that present as NS, pediatric incident NS without a diagnostic kidney biopsy and Alport syndrome. With the NEPTUNE Match precision medicine research platform, NEPTUNE connects patients' individual disease mechanisms to ongoing drug trials to ensure the right patients participate in the right trial at the right time. For more information, visit NEPTUNE-STUDY.org.

"我們很高興與Vera Therapeutics合作NEPTUNE Match。通過NEPTUNE獲得的對NS病理生物學的全新、顛覆性見解,現在我們可以針對特定的抗體介導性腎小球損傷。測試在識別出具有活躍抗體介導性疾病的患者中atacicept的療效,將確實將最新科學有意義地帶回給我們的研究參與者和急需新療法的患者。" Matthias Kretzler萬博士,密歇根大學醫藥學教授及NEPTUNE的首席研究員如此表示。
關於NEPTUNE
Nephrotic綜合徵研究網絡(NEPTUNE)是一個多地點協作研究,致力於對FSGS、MCD和MN等表現爲NS的疾病以及無診斷腎活檢的兒童起病NS和Alport綜合徵進行臨床和轉化研究。通過NEPTUNE Match精準醫學研究平台,NEPTUNE將患者的個體疾病機制與正在進行的藥物試驗相連接,以確保正確的患者在正確的時間參與正確的試驗。欲了解更多信息,請訪問NEPTUNE-STUDY.org。

About Vera
Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger's disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please visit .

維拉治療是一家專注於開發治療嚴重免疫性疾病的後期臨床階段生物技術公司。維拉的使命是推動針對免疫性疾病的治療手段,以改變患者的治療標準。維拉的首席產品候選人是atacicept,一種融合蛋白,每週自行皮下注射一次,可阻斷激活B細胞的因子(BAFF)和促進增生的配體(APRIL),這些會刺激B細胞和漿細胞產生自身抗體,導致某些自身免疫性疾病,包括IgAN,又稱伯傑氏病和狼瘡性腎炎。此外,維拉正在評估更多的疾病,atacicept可通過降低自身抗體來證明其在醫學上的可用性。維拉還在開發MAU868,一種單克隆抗體,旨在中和與BK病毒(BKV)感染,這是一種多瘤病毒,其在某些情況下(例如腎移植)可能會產生毀滅性後果。維拉保留atacicept和MAU868的所有全球開發和商業化權利。有關更多信息,請訪問。
Vera Therapeutics是一家專注於開發嚴重免疫疾病治療的晚期臨床階段生物技術公司。 Vera的使命是推進針對免疫疾病源頭的治療,以改變患者的治療標準。 Vera的首席產品候選藥物是atacicept,這是一種融合蛋白,每週一次經皮下注射自行用藥,可阻斷刺激b細胞產生自身抗體的B細胞激活因子(BAFF)和增殖誘導配體(APRIL)。這些抗體促進某些自身免疫疾病的發作,包括IgAN,又稱Berger氏病和狼瘡性腎炎。此外,Vera正在評估atacicept可能在減少自身抗體方面對醫學上有用的其他疾病。Vera還在開發MAU868,一種單克隆抗體,設計用於中和Bk病毒(BKV)感染,這是一種多瘤病毒,在某些情況下例如腎移植中可能具有毀滅性後果。 Vera保留對atacicept和MAU868的全球開發和商業權利。如需更多信息,請訪問 .

About Atacicept
Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis.

關於Atacicept
Atacicept是一種研究性重組融合蛋白,其中包含可溶性跨膜激活因子和鈣調節環肽酶配體相互作用物(TACI)受體,該受體結合細胞因子B細胞活化因子(BAFF)和增殖誘導配體(APRIL)。這些細胞因子是腫瘤壞死因子家族的成員,促進了與某些自身免疫疾病(包括IgAN和狼瘡性腎炎)相關的B細胞存活和自身抗體產生。

The Phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further reductions in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN.

20億ORIGIN臨床試驗顯示,atacicept在IgAN患者中實現了主要和關鍵的次要終點,經統計學顯著和臨床意義的蛋白尿減少,並在36周內與安慰劑相比穩定eGFR。在隨機期間的安全性與安慰劑相媲美。通過96周,atacicept進一步減少了Gd-IgA1、血尿和蛋白尿,同時穩定了eGFR,反映了與無IgAN患者一致的特點。

Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA's determination that, based on an assessment of data from the Phase 2b ORIGIN clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications.

Atacicept獲得了FDA突破性療法認定,用於治療IgAN,這反映了FDA根據20億ORIGIN臨床試驗數據評估得出的結論,即atacicept可能在臨床重要終點上相對於其他已有療法對IgAN患者有顯著改善。Vera相信atacicept具備一流潛力,通過定位b細胞以降低自身抗體,並已在不同適應症的臨床研究中應用於1500多名患者。

Forward-looking Statements
Statements contained in this press release regarding matters, events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Vera's expectations regarding the expansion of its development pipeline for atacicept, atacicept's potential to be a best-in-class treatment, Vera's expectations regarding the potential for B cell modulation through BAFF/APRIL dual inhibition to transform the treatment landscape for certain autoimmune diseases, Vera's plans to initiate the PIONEER study in 2025, Vera's anticipated presentations of clinical trial data, and Vera's product candidates, strategy, and regulatory matters. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "substantial," "will," "may," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera's business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

前瞻性聲明
本新聞稿中包含的關於未來可能發生的事項、事件或結果的陳述屬於"前瞻性陳述",依據1995年《私人證券訴訟改革法案》的定義。此類前瞻性陳述包括有關Vera對atacicept開發管線擴張的期望,atacicept有可能成爲最佳治療方案,Vera對通過BAFF/APRIL雙重抑制進行b細胞調節可改變某些自身免疫疾病治療格局的期望,Vera計劃於2025年啓動PIONEER研究,Vera預期的臨床試驗數據展示以及Vera的產品候選者、策略和監管事項。由於這些聲明可能受到風險和不確定性的影響,實際結果可能會與此類前瞻性陳述所表達或暗示的結果有實質性不同。"實質性"、"將會"、"可能"、"潛力"等詞語旨在識別前瞻性陳述。這些前瞻性陳述基於Vera當前的期望,並涉及一些未必會實現或可能證明是錯誤的假設。實際結果可能會與在此類前瞻性陳述中預期的結果有實質性不同,這是由於各種風險和不確定性,包括但不限於與監管批准流程相關的風險、先前臨床試驗結果可能無法在後續臨床試驗中獲得、初步結果可能無法預測頂線結果、與Vera業務總體相關的風險、宏觀經濟和地緣政治事件的影響,以及Vera在美國證券交易委員會的備案中描述的其他風險。本新聞稿中包含的所有前瞻性陳述僅於其發表日發表,並基於管理層在該日期的假設和估計。Vera無義務更新此類聲明以反映其發表日期後發生的事件或存在的情況,除非法律另有規定。

For more information, please contact:

更多信息,請聯繫:

Investor Contact:
Joyce Allaire
LifeSci Advisors
212-915-2569
jallaire@lifesciadvisors.com

投資者聯繫人:
喬伊斯·阿萊爾
LifeSci顧問
212-915-2569
jallaire@lifesciadvisors.com

Media Contact:
Madelin Hawtin
LifeSci Communications
MHawtin@lifescicomms.com

媒體聯繫:
Madelin Hawtin
通信-半導體
MHawtin@lifescicomms.com


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