New 48-week frexalimab phase 2 data support
potential for high sustained efficacy in multiple sclerosis
- Data support frexalimab as a potential
first-in-class, high-efficacy, non-lymphocyte depleting treatment
for relapsing multiple sclerosis
- 96% of participants receiving
high-dose intravenous frexalimab had no new Gd+ T1 lesions and an
annualized relapse rate of 0.04 after 48 weeks
- Sanofi has initiated global phase 3
studies of frexalimab in relapsing MS and non-relapsing secondary
progressive MS
Paris, April 17,
2024. Sanofi’s CD40L antibody, frexalimab, demonstrated
sustained reduction of disease activity and favorable 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,
US. Results from the 12-week double-blind study period were
previously published in The New England Journal of Medicine.
Patrick Vermersch, MD,
PhDUniversity of Lille, CHU Lille, France“These 48-week
data showed that treatment with frexalimab resulted in further
decreases in the number of lesions and a sustained reduction in
disease activity. The preliminary clinical results are promising
with a very low annual relapse rate. This strengthens the rationale
for targeting CD40L in MS and supports further development of
frexalimab as a potential high-efficacy 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
frexalimab, both on high- and low-dose regimens and participants
who switched from placebo at the start of the open-label extension
period (week 12), 87% (112/129) remained in the study at the
48-week cut-off. During the OLE, participants in the high- (n=50)
and low-dose (n=49) arms continued to receive frexalimab 1200 mg
intravenously every four weeks, or frexalimab 300 mg subcutaneously
every two weeks, respectively, while those initially receiving
placebo switched to the aforementioned high or low dose frexalimab
treatment arms (n=12 and n=14, respectively).
Erik Wallström, MD,
PhDGlobal Head of Neurology Development, Sanofi“Frexalimab
represents a novel potential first-in-class treatment mechanism in
multiple sclerosis designed to tackle the aspects of this disease
where unmet medical needs still exist. We are applying our deep
expertise to address the full spectrum of neuroinflammation and
neurodegeneration to improve the lives of people living with
multiple sclerosis.”
Results of the phase 2 OLE at week 48
showed:
- 96% of patients who continued
receiving high-dose frexalimab and 87% of those who continued
receiving low-dose frexalimab were free of Gd+ T1 lesions at week
48, respectively. Additionally, among patients who switched from
placebo to high and low-dose frexalimab at the start of the OLE at
week 12, declines were seen at Week 24, and 90% and 92% were free
of Gd+ T1 lesions at week 48, respectively.
- The number of Gd+ T1-lesions (mean
[SD]) remained low in participants who continued receiving
frexalimab (high dose: 0.0 [0.2]; low dose: 0.2 [0.5]) and
continued to decline in those who switched from placebo to
frexalimab at week 12 (high dose: 0.2 [0.6]; low dose: 0.1
[0.3]).
- Number of and volume change of new
or enlarging Gd+ T2-lesions remained low for all frexalimab
treatment groups through week 48, and lymphocyte counts remained
stable.
- Participants who continued
receiving high-dose frexalimab experienced a low annualized relapse
rate (ARR) of 0.04 (95% CI: 0.01, 0.18) over the 48-week treatment
period with 96% being free of relapses. ARR in the initial low-dose
arm was 0.22, and ARR in patients who switched to high and low-dose
frexalimab were 0.09 and 0.40, respectively, through week 48.
Frexalimab was generally well-tolerated through
week 48. The most common adverse events (≥10%) amongst all
subgroups of patients receiving frexalimab during OLE until cut-off
at week 48 from baseline were nasopharyngitis (n=14 [11%]),
headache (n=14 [11%]) and COVID-19 (n=13 [10%]).
About the phase 2 studyThe 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 (frexalimab 1200 mg
intravenously every four weeks, with an initial 1800 mg loading
dose) or low (frexalimab 300 mg subcutaneously every two weeks,
with an initial 600 mg loading dose) doses of 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.
About frexalimabFrexalimab (SAR441344) is a
potentially first-in-class second generation investigational
anti-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.
Sanofi is developing frexalimab under an exclusive license from
ImmuNext Inc. Frexalimab is being evaluated in phase 3 clinical
studies for Multiple Sclerosis and phase 2 clinical studies for
immunology indications and Type 1 Diabetes, and its safety and
efficacy have not been reviewed by any regulatory authority. For
more information on frexalimab clinical trials, please visit .
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across the world, 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.comVictor Rouault | +3333
6 70 93 71 40 | victor.rouault@sanofi.comTimothy
Gilbert |+ 1 516 521 2929 | timothy.gilbert@sanofi.com
Investor RelationsThomas Kudsk
Larsen | +44 7545 513 693 |
thomas.larsen@sanofi.comAlizé Kaisserian | +
33 6 47 04 12 11 | alize.kaisserian@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.comNathalie
Pham | + 33 7 85 93 30 17 |
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