Press Release: Phase 2 results demonstrate rilzabrutinib rapidly
reduced itch severity and significantly improved disease activity
in adults with chronic spontaneous urticaria
Phase 2 results demonstrate rilzabrutinib
rapidly reduced itch severity and significantly improved disease
activity in adults with chronic spontaneous urticaria
- Late-breaking data
at 2024 AAAAI showed rilzabrutinib, an oral BTK inhibitor,
significantly reduced weekly itch severity score (ISS7) as early as
the first week of treatment in adults with moderate to severe
CSU
- Data form the
basis for the Phase 3 CSU and prurigo nodularis programs to start
in 2024
- Pivotal Phase 3
readout in immune thrombocytopenia and Phase 2 readouts in asthma,
IgG4-related disease and warm autoimmune hemolytic anemia expected
in 2024
- Rilzabrutinib is
one of 12 potential blockbusters in Sanofi’s leading immunology
pipeline
Paris, February 24, 2024.
Positive results from the Phase 2 study RILECSU showed that
rilzabrutinib significantly improved itch, hives and urticaria in
adults with moderate-to-severe chronic spontaneous urticaria (CSU),
whose symptoms are not adequately controlled by H1 antihistamines.
These results were presented today in a late-breaking poster at the
2024 American Academy of Allergy, Asthma and Immunology (AAAAI)
Annual Meeting in Washington, DC and form the basis for the Phase 3
program which is on track to start in 2024.
Professor Marcus Maurer,
M.D.Professor of Dermatology and Allergy, Executive
Director of the Institute of Allergology at the Charité Berlin
“People with CSU are living with debilitating symptoms such as
intensely itchy recurrent hives, swelling, or both which can have a
high impact on their day-to-day lives. These data are promising
news for patients that cannot be controlled with standard-of-care
antihistamines – the possibility of controlling itch rapidly with
an oral medicine would offer an important advancement in the
treatment of this disease.”
Naimish Patel, M.D.Head of
Global Development, Immunology and Inflammation, Sanofi“These data
reinforce the potential of rilzabrutinib as a treatment option for
patients with moderate-to-severe CSU and we believe that the rapid
improvement of itch could make a meaningful difference in
alleviating the physical and psychosocial burden these patients
suffer from. Based on these data, later this year we will advance
rilzabrutinib into Phase 3 development in both CSU and prurigo
nodularis, another skin disorder characterized by relentless
itching. We also look forward to data readouts for rilzabrutinib in
2024 with the opportunity to further demonstrate its potential
impact across multiple immune-mediated diseases.”
Key Results In this
dose-ranging study, different doses of rilzabrutinib were
evaluated: 400 mg once every evening (QPM), 400 mg twice a day
(BID), 400 mg three times a day (TID).
In the intent-to-treat (ITT) population which
included either patients who were previously naïve or incomplete
responders to omalizumab, Rilzabrutinib 400 mg TID
demonstrated:
- Significant
reduction from baseline in weekly itch severity score (ISS7) at
Week 12, a key symptom of the disease, [least squares mean (LSM)
-9.58 vs -6.31, respectively; p=0.0181]. Significant changes in
ISS7 were seen as early as Week 1.
- Significant
reduction from baseline to week 12 in weekly urticaria activity
score (UAS7) [LSM -17.95 vs -11.20, respectively; p=0.0116].
- Significant reduction from baseline
to week 12 in weekly hives severity score (HSS7) [LSM -8.31 vs
-4.89; p<0.0100].
Rilzabrutinib was generally well-tolerated with
no events of cytopenia, bleeding or atrial fibrillation seen with
other BTK inhibitor. Treatment-emergent AEs occurring at a higher
frequency with rilzabrutinib vs placebo were diarrhea (29.3% TID
and BID, 7.9% QPM, 15% placebo), nausea (19.5% TID, 17.1% BID,
13.2% QPM, 5.0% placebo), headache (9.8% TID, 14.6% BID, 5.3% QPM,
0.0% placebo) and abdominal pain (0.0% TID, 12.2% BID, 2.6% QPM,
5.0% placebo).
Rilzabrutinib is currently under clinical
investigation, and its safety and efficacy have not been evaluated
by any regulatory authority.
About CSUCSU is an inflammatory skin condition
driven mainly by the activation of cutaneous mast cells, which
causes itchy recurrent hives, swelling, or both. CSU is typically
treated with H1 antihistamines and biologics; however, the disease
remains uncontrolled in up to 50% of patients, who are left with
limited alternative treatment options. These individuals continue
to experience debilitating symptoms that can significantly impact
quality of life.
About the RILECSU studyRILECSU is a 52-week
Phase 2 study, comprising a 12-week randomized, double-blind,
placebo-controlled, dose-ranging, efficacy and safety period,
followed by a 40-week open-label extension period.
RILECSU is evaluating rilzabrutinib in adult
patients with moderate-to-severe CSU who remain symptomatic despite
use of H1 antihistamine treatment and are either naïve to or
incomplete responders to omalizumab. The primary endpoint was
change from baseline in weekly itch severity score ISS7 at 12
weeks. Secondary endpoints include change from baseline in weekly
UAS7 at 12 weeks and change from baseline weekly HSS7 at 12
weeks.
Participants in the trial (n=160) were
randomized 1:1:1:1 to rilzabrutinib 400mg once every evening (QPM),
400mg twice a day (BID), 400mg three times a day (TID), or matching
placebo.
About RilzabrutinibRilzabrutinib is an oral,
reversible, covalent BTK inhibitor that has the potential to be a
first- or best-in-class treatment of a number of immune-mediated
diseases. BTK, expressed in B cells and mast cells, plays a
critical role in multiple immune-mediated disease processes. With
the application of Sanofi’s TAILORED COVALENCY® technology,
rilzabrutinib can selectively inhibit the BTK target while
potentially reducing the risk of off-target side effects.
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
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