Late-Breaking oral presentation shows that
cenerimod for the treatment of moderate to severe systemic lupus
erythematosus (SLE) in Japanese patients can be
considered safe and well-tolerated
Data shows a clinically meaningful improvement
in disease activity consistent with results from other global Phase
2 studies of cenerimod
PITTSBURGH, Aug. 23,
2024 /PRNewswire/ -- Viatris Inc. (NASDAQ:
VTRS), a global healthcare company, presented today the results of
one of its Phase 2 studies* of cenerimod (ACT-333441). The
ACT-333441 study was accepted as a late-breaking abstract and was
presented during an oral presentation at the 26th
Asia-Pacific League of Associations for Rheumatology (APLAR) Annual
Congress. The congress is being held August
21-25, 2024, in Suntec, Singapore.
The ACT-333441 study was a randomized, double-blind,
parallel-group, multicenter, Phase 2 study that was conducted in
Japan and evaluated the safety,
pharmacodynamics (PD), and efficacy of cenerimod, a selective
S1P1 receptor modulator, in 17 Japanese patients with
moderate to severe systemic lupus erythematosus (SLE). Adult
patients receiving SLE background treatment were randomized equally
to either 2 mg or 4 mg cenerimod (once-daily, oral dosing). The
primary endpoint of the study measured safety and tolerability, and
the secondary endpoint measured a change in total lymphocyte count
and the efficacy was assessed using a modified SLEDAI-2K
(mSLEDAI-2K) score.
Both cenerimod doses were considered safe and well-tolerated. A
decrease in lymphocyte counts was observed in both the 2 mg and 4
mg doses as expected per the mechanism of action of cenerimod and
was reversible upon treatment discontinuation. Both doses showed a
clinically meaningful improvement in disease activity, as measured
by mSLEDAI-2K, which persisted long after the treatment was
discontinued and was higher with the 4 mg dose. These results
are generally consistent with the global Phase 2 CARE study*.
Visit Viatris at APLAR at Booth #21-23 to learn more about the
study and how the company continues to support the needs of the SLE
community. The data was presented during the following oral
presentation:
- Cenerimod in Japanese patients with moderate to severe
systemic lupus erythematosus (SLE): A Phase 2, randomized,
double-blind trial
- Speaker: Sharavan Kanagaratnam
- August 23, 3:00 - 4:15 p.m.
GMT+8
- Abstract session 3: Late-breaking abstracts: Systemic lupus
erythematosus
Further details on the APLAR program can be accessed online
here.
About SLE
Systemic lupus erythematosus (SLE), the most
common form of lupus, is an autoimmune disease. While the cause of
SLE is not fully known, T and B lymphocytes are considered the key
immune cells that play a role in the development of SLE. In
individuals with SLE, both T and B cells become overactive,
infiltrate different tissues, and produce autoantibodies, leading
to inflammation and organ damage.
About cenerimod
Cenerimod is an investigational drug, a highly selective
S1P1 receptor modulator given as an oral once-daily
tablet. Cenerimod is an investigational drug that potentially
offers a novel approach for the treatment of SLE, a disease with a
significant impact on patients and limited treatment options.
In December 2022, the Oral S1P1 receptor
ModUlation in SLE (OPUS) program was initiated, which consists
of two multicenter, randomized, double-blind, placebo-controlled,
parallel-group Phase 3 studies to evaluate the efficacy, safety,
and tolerability of cenerimod in adult patients with
moderate-to-severe SLE on top of background therapy. The main
objectives of the program are to evaluate the effectiveness of
cenerimod 4 mg in reducing disease activity, as well as controlling
the disease, compared to placebo. The primary endpoint is response
on SRI-4 at month 12 compared to baseline. Secondary endpoints
include response on BICLA at month 12 compared to baseline and
measures of sustained disease control: time to first confirmed
4-month sustained mSLEDAI-2K response and time to first confirmed
4-month sustained response in mucocutaneous manifestations (i.e.,
rash, alopecia, mucosal ulcers).
The investigation of cenerimod for the treatment of SLE has
received Fast-Track designation from the U.S. Food and Drug
administration (FDA). This designation is intended to promote
communication and collaboration between the FDA and pharmaceutical
companies for drugs that treat serious conditions and fill an unmet
medical need.
*About the CARE study:
CARE was a Phase 2b, multicenter, randomized, double-blind,
placebo-controlled, parallel group study to evaluate the efficacy,
safety, and tolerability of cenerimod in subjects with moderate to
severe systemic lupus erythematosus (SLE). Patients with SLE,
mSLEDAI-2K ≥6 and history or presence of positive ANA or anti-dsDNA
were randomized to daily oral cenerimod (0.5, 1, 2 or 4 mg) or PBO.
Background SLE medication had to be stable for ≥30 days
pre-randomization (corticosteroids ≥15 days). Study duration was 18
months (M), two 6M treatment periods
and a 6M follow-up. After the first
6M, patients on cenerimod 4 mg were
rerandomized to cenerimod 2 mg or PBO to assess reversibility of
lymphopenia and potential withdrawal effects. Of 427 randomized
patients, 339 completed 12M of
treatment. The primary endpoint was change from baseline (BL) to M6
in mSLEDAI-2K. Secondary endpoints were SLE Responder Index SRI-4
and BILAG-2004 improvement. Safety endpoints included adverse
events (AEs) and AEs of special interest (AESI).
About Viatris
Viatris Inc. (NASDAQ: VTRS) is a global healthcare company
uniquely positioned to bridge the traditional divide between
generics and brands, combining the best of both to more
holistically address healthcare needs globally. With a mission to
empower people worldwide to live healthier at every stage of life,
we provide access at scale, currently supplying high-quality
medicines to approximately 1 billion patients around the world
annually and touching all of life's moments, from birth to the end
of life, acute conditions to chronic diseases. With our
exceptionally extensive and diverse portfolio of medicines, a
one-of-a-kind global supply chain designed to reach more people
when and where they need them, and the scientific expertise to
address some of the world's most enduring health challenges, access
takes on deep meaning at Viatris. We are headquartered in the U.S.,
with global centers in Pittsburgh,
Shanghai and Hyderabad, India. Learn more at
viatris.com and investor.viatris.com, and connect
with us on LinkedIn, Instagram, YouTube and
X (formerly Twitter).
Forward-Looking Statements
This press release includes statements that constitute
"forward-looking statements." These statements are made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Such forward looking statements may include
statements regarding the outcomes of clinical trials; that
late-breaking oral presentation shows that cenerimod for the
treatment of moderate to severe systemic lupus erythematosus (SLE)
in Japanese patients can be considered safe and well-tolerated;
that data shows a clinically meaningful improvement in disease
activity consistent with results from other global Phase 2 studies
of cenerimod; that both cenerimod doses were considered safe and
well-tolerated; that a decrease in lymphocyte counts was observed
in both the 2 mg and 4 mg doses as expected per the mechanism of
action of cenerimod and was reversible upon treatment
discontinuation; and that both doses showed a clinically meaningful
improvement in disease activity, as measured by mSLEDAI-2K, which
persisted long after the treatment was discontinued and was higher
with the 4 mg dose. Because forward-looking statements inherently
involve risks and uncertainties, actual future results may differ
materially from those expressed or implied by such forward-looking
statements. Factors that could cause or contribute to such
differences include, but are not limited to: actions and decisions
of healthcare and pharmaceutical regulators; changes in healthcare
and pharmaceutical laws and regulations in the U.S. and abroad; any
regulatory, legal or other impediments to Viatris' ability to bring
new products to market, including but not limited to "at-risk"
launches; Viatris' or its partners' ability to develop,
manufacture, and commercialize products; the scope, timing and
outcome of any ongoing legal proceedings, and the impact of any
such proceedings; the possibility that Viatris may be unable to
realize the intended benefits of, or achieve the intended goals or
outlooks with respect to, its strategic initiatives; the
possibility that Viatris may be unable to achieve intended or
expected benefits, goals, outlooks, synergies, growth opportunities
and operating efficiencies in connection with divestitures,
acquisitions, other transactions or restructuring programs, within
the expected timeframes or at all; goodwill or impairment charges
or other losses related to the divestiture or sale of businesses or
assets; Viatris' failure to achieve expected or targeted future
financial and operating performance and results; the potential
impact of public health outbreaks, epidemics and pandemics; any
significant breach of data security or data privacy or disruptions
to our information technology systems; risks associated with
international operations; the ability to protect intellectual
property and preserve intellectual property rights; changes in
third-party relationships; the effect of any changes in Viatris' or
its partners' customer and supplier relationships and customer
purchasing patterns; the impacts of competition; changes in the
economic and financial conditions of Viatris or its partners;
uncertainties and matters beyond the control of management,
including general economic conditions, inflation and exchange
rates; failure to execute stock repurchases consistent with current
expectations; stock price volatility; and the other risks described
in Viatris' filings with the Securities and Exchange Commission
(SEC). Viatris routinely uses its website as a means of disclosing
material information to the public in a broad, non-exclusionary
manner for purposes of the SEC's Regulation Fair Disclosure (Reg
FD). Viatris undertakes no obligation to update these statements
for revisions or changes after the date of this press release other
than as required by law.
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