UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQ: BIIB) today
presented detailed results from the Phase 3 PHOENYCS GO study
evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L
drug candidate, demonstrating significant clinical improvement in
disease activity in people living with moderate-to-severe systemic
lupus erythematosus (SLE). The results were shared during an oral,
late-breaker presentation at ACR Convergence 2024, the American
College of Rheumatology’s annual meeting, in Washington, DC.
“There remains a significant unmet need for
additional treatment options for people living with systemic lupus
erythematosus and the results we observed in PHOENYCS GO suggest
dapirolizumab pegol has the potential to be impactful for this
chronic and debilitating autoimmune disease. Across clinical
endpoints we observed a positive effect and a favorable safety
profile,” said Megan E.B. Clowse, M.D., principal investigator of
the study and Associate Professor of Medicine, Chief of the
Division of Rheumatology and Immunology at Duke University School
of Medicine. “Participants receiving dapirolizumab pegol
experienced reduced lupus activity while also tapering steroids,
changes important to people living with the disease.”
In the PHOENYCS GO study (n=321), dapirolizumab
pegol (DZP) was administered intravenously every four weeks. On the
primary endpoint measuring improvement of moderate-to-severe
disease activity as assessed by achievement of British Isles Lupus
Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA)
after 48 weeks, study participants receiving DZP plus SOC had a
statistically significant 14.6% (95% confidence interval [CI]: 3.3,
25.8; p=0.0110) higher response rate (49.5%) than those receiving
SOC alone (34.6%). A higher BICLA response rate reflects a
treatment response across all affected organs at baseline and is
associated with meaningful clinical benefit.
On the first secondary endpoint of BICLA
response at Week 24, study participants receiving DZP plus SOC had
a 7.9% higher response rate (46.6%) than those receiving SOC alone
(38.3%). However, the difference did not reach statistical
significance (95% CI: -3.6, 19.4; p=0.1776). Given statistical
significance was not achieved for the first key secondary endpoint
in the hierarchical testing, analyses for all the subsequent
secondary endpoints are descriptive and nominal p-values are
included.
Subsequent analyses of additional secondary
endpoints showed clinical improvements in the DZP group, including
SLE Responder Index (SRI)-4 response, corticosteroid tapering, SLE
Disease Activity Index-2K (SLEDAI-2K), achievement of Lupus Low
Disease Activity State (LLDAS) and prevention of severe BILAG
flares:
- 17.1% more participants receiving
DZP were able to reduce their corticosteroid dose from >7.5
mg/day prednisone equivalent at baseline to ≤7.5 mg/day at Week 48
(72.4% vs. 52.9%; difference [95% CI]: 17.1% [0.7, 33.4]; nominal
p=0.0404).
- 18.8% higher SRI-4 response rate at
Week 48 (95% CI: 7.3, 30.3; nominal p=0.0014) among study
participants who received DZP plus SOC (60.1%) versus those who
received SOC alone (41.1%).
- A 1.8-fold greater decrease from
baseline in SLEDAI-2K in study participants receiving DZP plus SOC
compared to SOC alone at Week 48 (-6.1 vs –4.2; difference [95%
CI]: -1.8 [-2.7, -0.9]; nominal p=0.0001).
- A 20.9% greater proportion of
participants in the DZP group achieved LLDAS at Week 48 compared to
SOC alone (40.9% vs. 19.6%; difference [95% CI]: 20.9% [10.7,31.2];
nominal p<0.001).
- Participants receiving DZP plus SOC
had 50% fewer severe BILAG flares through Week 48 (95% CI: 1.4,
21.6; nominal p=0.0257) compared to SOC alone (11.6% vs.
23.4%).
“Due to the varied symptoms and severity by
patient, progress in the treatment of lupus has historically been
challenging. With dapirolizumab pegol, we believe that our
differentiated approach that targets the CD40L pathway results in
clinically meaningful improvements across multiple disease domains
and could substantially impact the burden of this disease in
particular for women, who are disproportionately affected by
lupus,” said Fiona du Monceau, Head of Patient Evidence at UCB. “We
are highly encouraged by the results we have seen in PHOENYCS GO
and are excited to continue the clinical development of
dapirolizumab pegol in the second Phase 3 study, PHOENYCS FLY.”
The safety profile of dapirolizumab pegol was
generally favorable. The safety results were consistent with
previous DZP studies and with that in study participants with SLE
receiving an immunomodulator. In the PHOENYCS GO study, a higher
proportion of patients receiving DZP plus SOC had
treatment-emergent adverse events (TEAEs) compared to SOC alone
(82.6% vs. 75.0%). The proportion of participants with serious
TEAEs was 9.9% in those participants receiving DZP plus SOC
compared to 14.8% in those receiving SOC alone. Opportunistic
infections were reported in 2.8% of participants receiving DZP plus
SOC compared to 0.9% of those receiving SOC alone. Discontinuation
of treatment or study participation due to TEAEs occurred in 4.7%
(10) of participants receiving DZP plus SOC and 3.7% (4) of
participants receiving SOC alone.
“At Biogen, we understand that lupus affects
everyone differently and are committed to developing treatments as
diverse as the patients we serve,” said Diana Gallagher, MD, Head
of AD, MS and Immunology Development Units at Biogen. “These
results reinforce our belief that dapirolizumab pegol has the
potential to change the approach to care of SLE and we are
dedicated to advancing this program with our partner UCB.”
Participants from the PHOENYCS GO study will
continue to be followed in a long-term open-label study. In 2024,
UCB and Biogen will initiate a second Phase 3 trial of
dapirolizumab pegol, PHOENYCS FLY (NCT06617325).
The safety and efficacy of dapirolizumab pegol
in systemic lupus erythematosus have not been established, and it
is not approved for use in systemic lupus erythematosus by any
regulatory authority worldwide.
About Systemic Lupus Erythematosus
(SLE)SLE is a chronic, multifactorial autoimmune disease
that is caused by the activation of autoreactive T, B and
antigen-presenting cells, resulting in manifestations across
multiple organ systems with periods of illness or flares
alternating with periods of inactivity.1 SLE can present itself in
several ways including rash, arthritis, anemia, thrombocytopenia,
serositis, nephritis, seizures or psychosis.2 SLE is associated
with a greater risk of death from causes such as infection and
cardiovascular disease.
An estimated 90% of people living with lupus are
women; most begin to see symptoms between the ages of 15-55.3,4,5
Individuals from populations of African, Hispanic, Asian and Native
American descent are at a greater risk of earlier onset and more
aggressive disease.6,7 Pregnancy in women with SLE is high risk,
with higher maternal and fetal mortality and morbidity than the
general population.8,9
About Dapirolizumab
PegolDapirolizumab pegol is a novel investigational
humanized Fc-free polyethylene glycol (PEG)-conjugated
antigen-binding (Fab’) fragment. Dapirolizumab pegol inhibits CD40L
signaling which has been shown to reduce B cell activation and
autoantibody production, mitigate type 1 interferon (IFN)
secretion, and attenuate T cell and antigen-presenting cell (APC)
activation.10 Dapirolizumab pegol is presently in Phase 3 clinical
development for the treatment of systemic lupus erythematosus (SLE)
under a collaboration between UCB and Biogen.11
About UCBUCB, Brussels, Belgium
(www.ucb.com) is a global biopharmaceutical company focused on the
discovery and development of innovative medicines and solutions to
transform the lives of people living with severe diseases of the
immune system or of the central nervous system. UCB is listed on
Euronext Brussels (symbol: UCB).
About BiogenFounded in 1978,
Biogen is a leading biotechnology company that pioneers innovative
science to deliver new medicines to transform patient’s lives and
to create value for shareholders and our communities. We apply deep
understanding of human biology and leverage different modalities to
advance first-in-class treatments or therapies that deliver
superior outcomes. Our approach is to take bold risks, balanced
with return on investment to deliver long-term growth.
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Given these uncertainties, you should not place
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UCB is providing this information, including
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Additionally, information contained in this
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Biogen Safe Harbor This news
release contains forward-looking statements, including but not
limited to those relating to the potential benefits, safety and
efficacy of DZP; the timing and status of current and future
regulatory filings; risks and uncertainties associated with drug
development and commercialization; the potential of Biogen’s
commercial business and pipeline programs; the anticipated benefits
and potential of Biogen’s collaboration arrangements with UCB;
Biogen’s strategy and plans; and potential cost healthcare savings
related to biosimilars. These forward-looking statements may be
accompanied by words such as “aim,” “anticipate,” “believe,”
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“potential,” “possible,” “will,” “would” and other words and terms
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Results in early stage clinical trials may not be indicative of
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trials and do not ensure regulatory approval. You should not place
undue reliance on these statements.
These statements involve risks and uncertainties
that could cause actual results to differ materially from those
reflected in such statements, including without limitation, actual
timing and content of submissions to and decisions made by the
regulatory authorities regarding DZP; regulatory submissions may
take longer or be more difficult to complete than expected;
regulatory authorities may require additional information or
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10.1136/lupus-2017-000247. PubMed PMID: 29531773; PubMed Central
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Xu J, Sammaritano L, Salmon J, Lockshin M, et al. Trends in
Maternal and Fetal Outcomes Among Pregnant Women With Systemic
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Clinicaltrials.gov (NCT04294667). A Study to Evaluate the Efficacy
and Safety of Dapirolizumab Pegol in Study Participants With
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(PHOENYCS GO) 2023 [cited August 2024] Available at:
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2024.
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