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. 

Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek, one of "America's Climate Leaders" by USA Today and one of the "World's Best Companies" by TIME.

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