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 ActivityThe 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 SymptomatologyThe 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