New data from 48-week Phase 2 of flexaliumab support potential for high sustained efficacy in multiple sclerosis
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Data support flexaliumab's potential as a first-in-class, highly effective, non-lymphodepleting treatment for relapsing multiple sclerosis
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Ninety-six percent of participants who received high-dose intravenous flexaliumab had no new Gd+ T1 lesions, and the annual recurrence rate after 48 weeks was 0.04.
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Sanofi initiates global Phase 3 trial of flexalimab in relapsing MS and non-relapsing secondary progressive MS
Paris, April 17, 2024. Sanofi's CD40L antibody flexalimab demonstrated sustained reductions in disease activity and good tolerability after nearly one year in participants with relapsing multiple sclerosis. These data will be presented today at the American Academy of Neurology (AAN) 2024 Annual Meeting in Denver, Colorado, USA. Results from a 12-week double-blind study period were previously published. New England Medical Journal.
Patrick Vermarsch, MD
University of Lille, CHU Lille, France
“These 48-week data showed that treatment with flexaliumab further reduced the number of lesions and sustained reductions in disease activity. Preliminary clinical results are promising with very low annual recurrence rates. This strengthens the rationale for targeting CD40L in MS and supports further development of flexalimab as a potential highly effective therapy in relapsing MS.”
From the initial 12-week double-blind period, 97% (125/129) of study participants entered the open-label extension (OLE) of the Phase 2 study. Of all participants receiving flexalimab in both high-dose and low-dose regimens and those who switched from placebo at the beginning of the open-label extension period (week 12), 87% (112/129 participants) remained in the study at 48 days. – Weekly deadlines. During the OLE, participants in the high-dose group (n=50) and low-dose group (n=49) continued to receive flexalimab 1200 mg intravenously every 4 weeks or flexalimab 300 mg subcutaneously every 2 weeks, respectively. However, the first group receiving placebo was switched to the high-dose or low-dose flexaliumab treatment group as described above (n=12 and n=14, respectively).
Eric Wahlstrom, MD, PhD
Global Head of Neurology Development, Sanofi
“Flexalimab is a new, potentially first-in-class treatment mechanism in multiple sclerosis designed to address aspects of this disease for which there is still unmet medical need. We apply our deep expertise in addressing the full spectrum of neuroinflammation and neurodegeneration to improve the lives of people living with STD.”
Phase 2 OLE results at week 48 showed:
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Ninety-six percent of patients who continued on high-dose flexalimab and 87% of patients who continued on low-dose flexalimab were free of Gd+ T1 lesions at week 48, respectively. Additionally, patients who switched from placebo to high-dose and low-dose flexaliumab at the start of OLE at week 12 saw a reduction at week 24, with 90% and 92% free of Gd+ T1 lesions at week 48, respectively. Ta.
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Number of Gd+ T1 lesions (mean [SD]) remained low in participants who continued on flexaliumab (high dose: 0.0 [0.2];low dose: 0.2 [0.5]), continued to decrease in patients switching from placebo to flexalimab at week 12 (high dose: 0.2 [0.6]; low dose: 0.1 [0.3]).
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The number and volume changes of new or enlarged Gd+ T2 lesions remained low in all flexaliumab treatment groups until week 48, and lymphocyte counts remained stable.
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Participants who continued on high-dose flexaliumab experienced a low annualized relapse rate (ARR) of 0.04 (95% CI: 0.01, 0.18) over the 48-week treatment period, and 96% did not relapse. The initial low-dose group had an ARR of 0.22, and patients who switched to high-dose and low-dose flexaliumab had ARRs of 0.09 and 0.40 by week 48, respectively.
Flexalimab was generally well tolerated up to week 48. From baseline to his 48 week cutoff, the most common adverse event (≥10%) among all subgroups of patients receiving flexalimab during OLE was nasopharyngitis (n = 14) [11%]), headache (n=14) [11%]) and novel coronavirus infection (n=13) [10%]).
About Phase 2 study
The phase 2 study was a randomized, double-blind, placebo-controlled trial evaluating flexalimab in participants with relapsing MS. Participants received either a high dose (flexalimab 1,200 mg intravenously every 4 weeks, initial loading of 1,800 mg) or a low dose (flexalimab 300 mg subcutaneously every 2 weeks, initial loading of 600 mg). Randomized (4:4:1:1). Dose) of flexaliumab or matching placebo for 12 weeks (Part A). The primary endpoint was a reduction in the number of new Gd+ T1 MRI brain lesions at week 12. Secondary endpoints included flexaliumab safety, tolerability, and pharmacokinetics, as well as additional MRI-based efficacy assessments. After 12 weeks, participants who received placebo were switched to their respective flexaliumab arm and entered the ongoing open-label Part B.
About flexaliumab
Flexalimab (SAR441344) is a first-in-class drug that blocks the costimulatory CD40/CD40L pathway, which is important for the activation and function of adaptive cells (T cells and B cells) and innate cells (macrophages/microglia and dendritic cells). A potential second-generation investigational anti-CD40L antibody. cell) immunity. Through this unique upstream mechanism of action, flexalimab has the potential to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion. Sanofi is developing flexalimab under exclusive license from ImmuNext Inc. Flexalimab is being evaluated in a phase 3 clinical study in multiple sclerosis and a phase 2 clinical study in immunological indications and type 1 diabetes, but its safety and efficacy remain unclear. It has not been reviewed by any regulatory authority. . For more information about flexalimab clinical trials, please visit.
About Sanofi
We are an innovative global healthcare company with one purpose: Pursuing the miracles of science to improve people's lives. Around the world, our teams are dedicated to transforming health care, working to turn the impossible into the possible. We bring potentially life-changing treatment options and life-saving vaccine protection to millions of people around the world, keeping sustainability and social responsibility at the heart of our goals. .
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