Amgen has reported the latest findings from its Phase II clinical trial of the investigational medicine, dazodalibep, to treat patients with Sjögren’s syndrome, an autoimmune disease.
The placebo-controlled, double-blind, randomised, crossover trial is designed to analyse dazodalibep in two Sjögren’s populations.
These groups included subjects with moderate to severe systemic disease activity, as well as people with moderate to severe symptomatology but no further organ involvement.
According to the latest trial findings, dazodalibep was shown to offer an improvement in systemic and symptomatic disease burden in these subject groups.
The treatment was found to be safe and well-tolerated in both groups.
In May 2023, the company reported that both patient populations who received treatment with dazodalibep met the primary endpoint at day 169.
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Amgen research and development executive vice-president David Reese said: “To date, there are no FDA-approved disease-modifying treatments for Sjögren’s and the positive results from the Phase II 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.”
A CD40 ligand antagonist, dazodalibep is presently being evaluated in a Phase III trial in patients with Sjögren’s.
The company also intends to analyse the therapy in individuals with focal segmental glomerulosclerosis, a rare kidney disorder.
Amgen recently reported that its Krystexxa (pegloticase) therapy offered a reduction in blood pressure in chronic gout patients in the MIRROR trial.