Dazodalibep improves disease activity, symptoms in two Sjögren’s syndrome populations
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Dazodalibep has successfully improved disease activity and symptoms two patient populations with Sjögren’s syndrome in a phase 2 trial, according to a press release from Horizon Therapeutics.
The company added that dazodalibep (VIB4920, Horizon), a CD40 ligand antagonist, is currently the only drug in development to achieve the primary endpoint in these populations in a phase 2 trial.
“There are currently no disease-modifying FDA-approved treatments for Sjögren’s and the population in this trial represents a large subset of patients who have a clear unmet clinical need,” Frederick B. Vivino, MD, MS, former director of the Penn Sjögren's Center and chief of the division of rheumatology at Penn Presbyterian Medical Center, part of the University of Pennsylvania Perelman School of Medicine, said in the press release.
“Participants in this study had been excluded from other recent trials, despite their substantial disease burden,” he added. “The positive results from the phase 2 trial are very promising in addressing many debilitating symptoms of people living with Sjögren’s.”
The trial included two distinct patient populations. The first included 74 patients with moderate-to-high systemic disease activity, defined by an ESSDAI score of at least 5. The second, meanwhile, included 109 patients with moderate-to-severe subjective symptoms, defined by an EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score of at least 5, and residual stimulated salivary flow but with mild systemic disease activity, defined by an ESSDAI score of less than 5.
Following a 4-week screening period, patients were randomized to receive either intravenous dazodalibep or placebo. After 24 weeks of treatment, patients initially randomized to placebo began receiving dazodalibep for the remainder of the 40-week treatment period, and vice-versa. Patients were followed for 12 weeks after the end of the treatment period.
In the first patient population, those receiving dazodalibep achieved a 6.3-point reduction in their ESSPRI scores, compared with a 4.1-point reduction in those receiving placebo (P = .017).
In the second patient population, at day 169, patients who had been treated with dazodalibep saw a 1.8-point reduction in ESSPRI scores, compared with a 0.53-point reduction in patients who received placebo (P = .0002).
Secondary points, which assessed quality-of-life measures such as fatigue, were also achieved in a statistically significant manner, according to the release. In addition, the drug was well-tolerated in both populations, with the most common adverse events being COVID-19 infection, nasopharyngitis and anemia, the release said.
“It is remarkable to see how these data demonstrated a significant separation in symptom intensity in patients treated with dazodalibep, compared to placebo, and this reinforces the potential of dazodalibep’s mechanism of action for patients suffering with the disease,” Elizabeth H.Z. Thompson, PhD, executive vice president of research and development for Horizon, said in the release. “Following these positive data, we look forward to working with regulators to continue developing dazodalibep as a potential treatment to positively impact the severe symptomatology of people living with this disease and improve their quality of life.”
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