AMGEN PRESENTS NEW DATA FROM PHASE 2 TRIAL OF DAZODALIBEP IN SJÖGREN'S SYNDROME AT ACR 2023
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
Key findings include:
Patients with Moderate to Severe Symptomatology
Key findings include:
"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 Sjögren's Syndrome
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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