First Phase 2 Trial in Sjögren's to Achieve
the Primary Endpoint Both in Patients With Severe Symptomatology
and Those With Systemic Disease
Results From Crossover Period Provide Further
Evidence of the Clinical Efficacy and Safety of Dazodalibep in
Sjögren's
THOUSAND
OAKS, Calif., Nov. 7, 2023
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from
its Phase 2 study evaluating dazodalibep, an investigational
medicine, for the treatment of Sjögren's. These results will be
featured in presentations at the American College of Rheumatology
(ACR) Convergence 2023, Nov. 10-15,
in San Diego. Findings from the
study demonstrate that dazodalibep may improve both the systemic
and symptomatic disease burden of two different patient
populations.
The Phase 2 study of dazodalibep, a CD40 ligand antagonist in
clinical development, was a randomized, double-blind,
placebo-controlled crossover study evaluating two Sjögren's
populations: patients with moderate to severe systemic disease
activity and those with moderate to severe symptomatology despite
lacking additional organ involvement. In May
2023, presentations at the 2023 EULAR Congress reported
that at Day 169, both patient groups treated with dazodalibep
achieved the study's primary endpoint. The presentations at ACR
highlight results from the crossover period, when at Day 169,
patients initially treated with dazodalibep transitioned to
placebo, and patients that initially received placebo switched to
dazodalibep. After administration of the last dose, patients were
followed for an additional 12 weeks for safety.
"To date, there are no FDA-approved disease-modifying treatments
for Sjögren's and the positive results from the Phase 2 trial
provide evidence that dazodalibep may address the underlying causes
of the disease by reducing systemic disease activity and improving
the debilitating symptoms such as dryness and fatigue," said
David M. Reese, M.D., executive vice
president of Research and Development at Amgen.
The company is advancing a Phase 3 trial evaluating the benefit
of dazodalibep in Sjögren's.
Patients with Moderate to Severe Systemic Disease
Activity
The first patient population included patients with
moderate to severe systemic disease activity as defined by a EULAR
Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥5.
Key findings include:
- Patients who transitioned from placebo to dazodalibep
experienced an improvement in their disease activity from Day 169
(4.1-point reduction in total ESSDAI score) to Day 365 (6.3-point
reduction).
- At Day 365, patients who transitioned to dazodalibep also
showed greater improvements in ESSDAI response rate (3- to 4-point
reduction), EULAR Sjögren's Syndrome Patient Reported Index
(ESSPRI) score and fatigue compared to those who transitioned to
placebo.
- Dazodalibep was generally safe and well tolerated.
Patients with Moderate to Severe Symptomatology
The
second patient population studied included those with moderate to
severe symptomatology including dryness, fatigue and pain despite
lacking additional organ involvement as defined by an ESSPRI score
≥5 and an ESSDAI score of <5.
Key findings include:
- Patients who transitioned from placebo to dazodalibep
experienced further improvement in total ESSPRI score from Day 169
(0.5-point reduction) to Day 365 (1.3-point reduction).
- For patients who transitioned from dazodalibep to placebo,
the improvements in total ESSPRI score achieved at Day 169
(1.8-point reduction) were largely sustained through Day 365
(1.9-point reduction).
- Patients who transitioned to dazodalibep also showed
improvements in measurements of fatigue and the Patient Global
Impression of Severity (PGI-S) from Day 169 to Day 365.
- Dazodalibep was generally safe and well tolerated.
"Sjögren's can be a devastating disease that significantly
impacts a person's quality of life and can lead to serious medical
outcomes," said E. William St.
Clair, M.D., professor of medicine, Duke University Medical Center. "The results from
this Phase 2 clinical trial are very encouraging and provide
evidence that dazodalibep may be an effective therapy for
addressing the significant disease burden of people living with
Sjögren's."
About Dazodalibep
Dazodalibep is a CD40 ligand
antagonist that blocks T cell interaction with CD40-expressing B
cells, disrupting the overactivation of the CD40 ligand
co-stimulatory pathway. Several autoimmune diseases are associated
with the overactivation of this pathway. Amgen also plans to
investigate dazodalibep in focal segmental glomerulosclerosis, a
rare kidney disorder characterized by scarring of glomeruli.
About Sjögren's Syndrome
Sjögren's syndrome is a
chronic, systemic autoimmune disease affecting exocrine glands,
primarily the salivary and tear glands, with severe cases affecting
multiple organs. Like other autoimmune diseases, Sjögren's syndrome
primarily affects women. The disease also has an increased risk of
non-Hodgkin's B-cell lymphoma and there is an unmet medical need
for patients with extraglandular disease manifestations, as
currently there is no therapy that can improve or slow the course
of the disease. Disease manifestations include dry mouth, dry eyes,
arthritis and kidney or lung dysfunction.
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one
of the world's leading independent biotechnology
companies, has reached millions of patients around the world and is
developing a pipeline of medicines with breakaway
potential.
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