Studies Demonstrate Positive Efficacy, Safety Data of Dazodalibep for Sjögren’s Syndrome

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Data indicate dazodalibep has the potential to address unmet therapeutic needs for patients with Sjögren’s syndrome.

In an interview with HCPLive Rheumatology, Ilias Alevizos, DMD, PhD, executive medical director, Horizon, discusses the phase 2 dazodalibep efficacy and safety data that will be presented at the European Congress of Rheumatology (EULAR) 2023. The data indicate dazodalibep has the potential to address the unmet therapeutic needs for patients with Sjögren’s syndrome, a condition which currently has no approved disease-modifying therapies.

Investigators evaluated the drug on 2 different populations: those with moderate-to-severe systemic disease activity as well as a second population, often unrepresented in clinical trials, assessing symptoms such as dryness, pain, and fatigue, among other endpoints.

As there is no approved drug for Sjögren’s, treatment and management are generally performed through palliative care, usually focused on temporarily decreasing dryness. Alevizos was excited that dazodalibep treatment was able to provide relief for symptomatic burden, which is often very severe debilitating for these patients. The drug also improved systemic disease activity which, if untreated, can lead to organ damage and death.

His team is currently working with regularly agencies worldwide to help design a phase 3 study, expected to begin in 2023, which Alevizos hopes will confirm and replicate the findings from the phase 2 trial.

“Not only were we able to meet the primary endpoint, but we had clinically meaningful and significant improvement in many other secondary endpoints,” Alevizos stated. “Within the study population, we observed that treatment with dazodalipeb demonstrated a multitude of positive trends, and we find that very interesting and exciting.”

This transcript was edited for clarity.