Media Update: Frexalimab New Phase 2 Data Showed Reduction of Key Biomarker of Nerve Cell Damage in Relapsing MS
Media Update: Frexalimab New Phase 2 Data Showed Reduction of Key Biomarker of Nerve Cell Damage in Relapsing MS
Frexalimab new phase 2 data showed reduction of key biomarker of nerve cell damage in relapsing MS
Frexalimab新的2期數據顯示在複發性多發性硬化中降低神經細胞損傷的關鍵生物標誌物。
- Frexalimab high-dose arm observed a 41% reduction in plasma neurofilament light chain (NfL) levels, a biomarker of nerve cell damage, after 48 weeks of treatment
- Data support potential as a first-in-class, high-efficacy, and disease-modifying treatment for people with relapsing MS
- Phase 3 studies of frexalimab in relapsing MS and non-relapsing secondary progressive MS (nrSPMS) are underway
- Frexalimab高劑量組觀察到神經細胞損傷生物標誌物——血漿神經絲輕鏈(NfL)水平下降41%,治療48周後;
- 數據支持作爲首個高效、疾病修飾性治療複發性多發性硬化症的治療方法。
- Frexalimab 在複發性多發性硬化症和非複發性二級進行性多發性硬化症(nrSPMS)的三期研究正在進行中。
Paris, June 28, 2024. Sanofi's CD40L monoclonal antibody, frexalimab, reduced a key biomarker associated with multiple sclerosis nerve cell damage in patients with relapsing MS, supporting the rationale for this novel mechanism in MS phase 3 studies aiming to delay disability progression. New phase 2 results showed significant reduction in plasma levels of neurofilament light chain (NfL) after one year of treatment, a biomarker of nerve cell damage that is typically elevated in people living with MS. These data were presented at the 10th Congress of the European Academy of Neurology (EAN) in Helsinki, Finland.
2024年6月28日,賽諾菲的CD40L單克隆抗體Frexalimab減少了複發性多發性硬化患者神經細胞損傷相關的關鍵生物標誌物,支持在MS 3期研究中延遲殘疾進展的新機制。新的2期結果顯示,在經過一年的治療後,神經纖維輕鏈(NfL)的血漿水平明顯降低,這是通常在患有MS的人中升高的神經細胞損傷的生物標誌物。這些數據在芬蘭赫爾辛基歐洲神經學學會(EAN)第10屆會議上發表。
Patrick Vermersch, MD, PhD
University of Lille, CHU Lille, France
"As our science and diagnostic tools have evolved, so has our understanding of multiple sclerosis. We now know that NfL levels may be related to both acute inflammatory damage and chronic diffuse neuronal loss leading to disability progression, strengthening its position as a key biomarker of nerve cell damage in people with multiple sclerosis. These data presented at EAN suggest that CD40L inhibition may reduce nerve cell damage in people with multiple sclerosis and reinforce the potential of frexalimab to slow or halt disease progression for people living with this disease."
Patrick Vermersch博士,博士後,法國里爾大學,里爾CHU。
法國里爾大學,里爾CHU。
"隨着我們的科學和診斷工具的進步,我們對多發性硬化的理解也在不斷加深。我們現在知道,NfL水平可能與急性炎症損傷和慢性瀰漫性神經元損失相關,並導致殘疾進展,從而加強了它在患有多發性硬化人群中作爲神經細胞損傷的關鍵生物標誌物的地位。 EAN上呈報的這些數據表明,CD40L抑制可能減少患有多發性硬化的神經細胞損傷,並強化Frexalimab減緩或阻止該疾病對患者造成的進展潛力。."
Erik Wallström, MD, PhD
Global Head of Neurology Development, Sanofi
"People with multiple sclerosis need new high-efficacy treatment options that target disability progression, which remains an unmet need. These results, alongside the previously reported phase 2 efficacy and safety results, further show that frexalimab's novel mechanism of action has the potential to deliver meaningful improvements for people living with this chronic and debilitating disease."
Erik Wallström博士
賽諾菲公司神經學開發全球負責人
"患有多發性硬化的人需要有針對殘疾進展的新高效治療選擇,而這仍然是未被滿足的需求。除了之前報道的2期療效和安全性結果之外,這些結果進一步表明Frexalimab的新機制有潛力爲患有這種慢性疾病的人提供有意義的改善。"
Ninety-seven percent (125/129) of the study participants from the initial 12-week double-blind period entered the open-label extension (OLE) of the phase 2 study, and 87% (112/129) remained in the study by the 48-week cut-off. During the OLE, treatment groups consisted of participants with relapsing MS receiving either high-dose frexalimab regimens (frexalimab-high), low-dose frexalimab regimens (frexalimab-low), or placebo-matched groups that switched to matching high or low doses of frexalimab at week 12 (placebo-low/frexalimab-low and placebo-high/frexalimab-high). Plasma NfL samples were collected and analyzed from all four groups at baseline, week 12, week 24, and week 48.
最初的12周的雙盲期參與者中,97%(125/129)參加了2期研究的開放式延伸(OLE),並且87%(112/129)在48周的截止日期前仍在研究中。在OLE期間,治療組包括接受高劑量Frexalimab方案(Frexalimab-high),低劑量Frexalimab方案(Frexalimab-low)或安慰劑匹配組,在第12周切換到匹配的高或低Frexalimab劑量(安慰劑低/ Frexalimab-low和安慰劑高/ Frexalimab-high)。所有四個組在基線,第12周,第24周和第48周進行了血漿NfL樣本收集和分析。
NfL biomarker results from the phase 2 study showed:
2期研究的NfL生物標誌物結果顯示:
- Plasma NfL levels (geometric mean pg/ml [SD]) were similar across all study groups at baseline and were reduced across all four treatment groups by week 48.
- Participants receiving high-dose frexalimab experienced a 41% reduction in plasma NfL levels from baseline (11.5 [1.9]) to week 48 (6.8 [2.0]), the greatest NfL level reduction across the four treatment groups.
- Participants receiving low-dose frexalimab experienced a 35% reduction in plasma NfL levels from baseline (12.4 [1.9]) to week 48 (8.1 [1.7]).
- Participants in the placebo-high group who switched to high-dose frexalimab at week 12 experienced a 24% reduction in plasma NfL levels from baseline (12.6 [2.1]) to week 48 (9.6 [1.7]) and by 39% from week 12 when switched from placebo to high-dose frexalimab.
- Participants in the placebo-low group who switched to low-dose frexalimab at week 12 experienced a 33% reduction in plasma NfL levels from baseline (11.8 [1.9]) to week 48 (7.8 [2.1]) and by 39% from week 12 when switched from placebo to low-dose frexalimab.
- 基線時血漿NfL水平(幾何平均pg / ml [SD])在所有研究組中相似,並在48周內在所有四個治療組中降低。
- 接受高劑量Frexalimab的參與者從基線(11.5 [1.9])到第48周(6.8 [2.0])的血漿NfL水平降低了41%,這是四個治療組中最大的NfL水平降低。
- 接受低劑量Frexalimab的參與者從基線(12.4 [1.9])到第48周(8.1 [1.7])的血漿NfL水平降低了35%。
- 安慰劑高組中在第12周切換到高劑量Frexalimab的參與者從基線(12.6 [2.1])到第48周(9.6 [1.7])的血漿NfL水平降低了24%,當從安慰劑切換到高劑量Frexalimab時,從第12周開始下降39%。
- 安慰劑低組中在第12周切換到低劑量Frexalimab的參與者從基線(11.8 [1.9])到第48周(7.8 [2.1])的血漿NfL水平降低了33%,當從安慰劑切換到低劑量Frexalimab時,從第12周開始下降39%。
In February 2024, 12-week double-blind study period results were published in The New England Journal of Medicine, and at AAN in April 2024, 48-week open-label extension efficacy and safety data were featured in an oral presentation.
2024年2月的12周雙盲期研究結果反孿生體注6-義務和 contingencies 的基本報表備註(未經審計),包含在本報告的第I部分第1項中。《新英格蘭醫學雜誌》以及在2024年4月的AAN上,48周的開放式延伸療效和安全性數據也在口頭陳述中亮相。
Sanofi has initiated global phase 3 studies of frexalimab in relapsing MS (NCT06141473) and non-relapsing secondary progressive MS (NCT06141486), which have begun enrolling participants.
賽諾菲已經開始在複發性多發性硬化(NCT06141473)和非複發性次進展性多發性硬化(NCT06141486)中的全球3期研究招募參與者。
About the phase 2 study
The phase 2 study was a randomized, double-blind, placebo-controlled study evaluating frexalimab in participants with relapsing MS. Participants were randomized (4:4:1:1) to receive either high dose (frexalimab 1200 mg intravenously every four weeks, with an initial 1800 mg loading dose) or low dose (frexalimab 300 mg subcutaneously every two weeks, with an initial 600 mg loading dose) frexalimab or matching placebo for 12 weeks (part A). The primary endpoint was the reduction in the number of new Gd+ T1 MRI brain lesions at week 12. Secondary endpoints included additional MRI-based efficacy measures as well as the safety, tolerability, and pharmacokinetics of frexalimab. After week 12, participants receiving placebo switched to respective frexalimab arms and entered the open-label part B, which is currently ongoing.
關於2期研究
2期研究是一項隨機,雙盲,安慰劑對照的研究,評估Frexalimab在複發性MS患者中的應用。參與者隨機分配(4:4:1:1)接受高劑量(每4周1200mg Frexalimab靜脈注射,初始1800mg負荷劑量)或低劑量(每2周300mg Frexalimab皮下注射,初始600mg負荷劑量)的Frexalimab或相匹配的安慰劑,爲期12周(A部分)。主要終點是在第12周減少新的Gd + T1 MRI腦部病變的數量。次要終點包括額外的MRI基礎療效措施以及Frexalimab的安全性,耐受性和藥代動力學。第12周後,接受安慰劑的參與者切換到相應的Frexalimab療程,並進入目前正在進行的開放式B部分。
About frexalimab
Frexalimab (SAR441344) is a potentially first-in-class second-generation CD40L antibody that blocks the costimulatory CD40/CD40L pathway which is important for activation and function of adaptive (T and B cells) and innate (macrophages/microglia and dendritic cells) immunity. Through this unique upstream mechanism of action, frexalimab has the potential to address both acute and chronic neuroinflammation in MS, without causing lymphocyte depletion. Frexalimab has significant indications under development, such as phase 2 studies in systemic lupus erythematosus and Type 1 diabetes, and its safety and efficacy have not been reviewed by any regulatory authority. Sanofi is developing frexalimab under an exclusive license from ImmuNext Inc. For more information on frexalimab clinical studies, please visit www.ClinicalTrials.gov.
關於Frexalimab
Frexalimab(SAR441344)是一種可能的第二代CD40L抗體,可阻斷重要的共刺激CD40 / CD40L途徑,該途徑對適應性(T和B細胞)和先天性(巨噬細胞/微膠質細胞和樹突狀細胞))免疫的激活和功能很重要。通過這種獨特的上游作用機制,Frexalimab有望在不造成淋巴細胞消耗的情況下解決MS中的急性和慢性神經炎症問題。Frexalimab具有正在開發的重要跡象,例如全身性紅斑狼瘡和1型糖尿病的2期研究,其安全性和療效尚未得到任何監管機構的審查。賽諾菲正在根據ImmuNext Inc.的獨家許可開發Frexalimab。有關Frexalimab臨床研究的更多信息,請訪問www。臨床試驗.gov。
About Sanofi
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