Positive Phase 2 data of novel investigational
anti-CD40L antibody frexalimab show significantly reduced disease
activity in relapsing multiple sclerosis
- Frexalimab met
primary endpoint with 89% reduction in new gadolinium-enhancing T1
brain lesions achieved at Week 12 in the higher-dose treatment arm,
compared with placebo
- Sanofi plans to
initiate pivotal trials in multiple sclerosis in early 2024
Paris,
May 31
2023. New data,
being presented in a late-breaking session at the 2023 Consortium
of Multiple Sclerosis Centers (CMSC) annual meeting, demonstrate
that frexalimab, Sanofi’s novel second-generation investigational
anti-CD40L antibody, with a unique mechanism of action,
significantly reduced disease activity in a Phase 2 trial of
patients with relapsing multiple sclerosis (MS). Following 12 weeks
of therapy, the number of new gadolinium-enhancing (GdE) T1-lesions
was reduced by 89% and 79% in the higher- and lower-dose treatment
arms, respectively, compared with placebo, meeting the study’s
primary endpoint.
A substantial unmet need remains in MS for
highly effective and well-tolerated treatment options that provide
sustainable control of disease activity and disability progression,
while minimizing risks. As the first second-generation anti-CD40L
antibody to show efficacy in MS, frexalimab is thought to block the
costimulatory CD40/CD40L cellular pathway necessary for adaptive (T
and B cells) and innate (macrophages and dendritic cells) immune
cell activation and function, without lymphocyte-depletion.
Erik
Wallström, MD, PhD Global Head of
Neurology Development, Sanofi"Building on our 20 years of research
and development in multiple sclerosis, we are committed to growing
our robust pipeline of MS therapies by exploring multiple treatment
approaches with unique MOAs that have the potential to slow or halt
disability, which remains one of the greatest unmet medical needs
in multiple sclerosis today.”
Gavin Giovannoni, MD, PhD, FCP,
FRCP, FRCPathChair of Neurology, Blizard
Institute, Barts and The London School of Medicine and Dentistry,
Queen Mary University of London"Frexalimab has a unique mechanism
of action, blocking the CD40/CD40L costimulatory pathway thought to
regulate both adaptive and innate immune cell activation and
function – a pathway that is pivotal in the pathogenesis of MS. We
are thrilled with the results achieved with frexalimab in just 3
months, which shows that CD40L inhibition rapidly controls MS
disease activity without lymphocyte depletion.”
Pivotal trials in MS are planned to be launched
in 2024.
About the Phase 2 studyThe Phase 2 study was a
randomized, double-blind, placebo-controlled trial evaluating
frexalimab in patients with relapsing MS. In the trial, 129
patients with relapsing MS were randomized (4:4:1:1) to receive
either higher or lower doses of frexalimab (n=52 and n=51,
respectively) or matching placebo (n=12 and n=14, respectively;
pooled for efficacy analyses) for 12 weeks (Part A). After Week 12,
patients receiving placebo switched to respective frexalimab arms
and entered the open-label Part B, which is currently ongoing. The
primary endpoint was the reduction in the number of new GdE
T1-hyperintense MRI brain lesions after 12 weeks of treatment.
Secondary endpoints included additional MRI-based efficacy measures
as well as the safety, tolerability and pharmacokinetics of
frexalimab.
In the study, both groups receiving higher or
lower doses of frexalimab had significant reductions in new GdE
T1-hyperintense lesions after 12 weeks of treatment. At Week 12,
high- and low-dose frexalimab significantly reduced the number
of new GdE T1-lesions by 89% (95%CI: 62%-97%, p=0.0004) and 79%
(95%CI: 44%-92%, p=0.0021), respectively, versus placebo (pooled
dose groups). Additionally, both groups treated with frexalimab
showed reductions in new or enlarging T2-lesions and total GdE
T1-lesions. At Week 24, 96% of participants in the higher-dose
frexalimab arm were free of new GdE T1-lesions. Early effects (Week
12) on MSIS-29 physical impact score (a patient-reported outcome)
and plasma neurofilament light chain (NfL) levels will also be
reported.
Frexalimab was well-tolerated, and 125 (97%)
patients completed Part A and continued to the open-label Part B.
The most common adverse events (≥4%) in any frexalimab-treated
group were COVID-19 (n=5 [9.8%] in the lower-dose group; all
uncomplicated cases of mild or moderate intensity) and headache
(n=1 [2.0%] and n=3 [5.8%] in the lower- and higher-dose group,
respectively).
About frexalimabFrexalimab (SAR441344) is a
novel monoclonal antibody that is thought to block the
costimulatory CD40/CD40L cellular pathway necessary for adaptive (T
and B cells) and innate (macrophages and dendritic cells) immune
cell activation and function, without lymphocyte-depletion. Sanofi
is developing SAR441344 under an exclusive license from ImmuNext
Inc. Frexalimab is an investigational product, and its safety and
efficacy has not been reviewed by any regulatory authority.
About Sanofi We are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY
Media RelationsSandrine
Guendoul | + 33 6 25 09
14 25 | sandrine.guendoul@sanofi.comSally
Bain | + 1 617 834 6026
| sally.bain@sanofi.com Investor
RelationsEva Schaefer-Jansen | + 33 7 86
80 56 39
| eva.schaefer-jansen@sanofi.comArnaud
Delépine | + 33 6 73 69
36 93 | arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 6 40 56 92 21 |
corentine.driancourt@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comTarik
Elgoutni| + 1 617 710 3587
| tarik.elgoutni@sanofi.comNathalie
Pham | + 33 7 85 93 30 17 |
nathalie.pham@sanofi.com
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