Investigational Treatment Dapirolizumab Pegol Shows Positive Results in Phase 3 Clinical Trial
Investigational Treatment Dapirolizumab Pegol Shows Positive Results in Phase 3 Clinical Trial

September 24, 2024

Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, is proud to share positive topline results from the Phase 3 PHOENYCS GO study evaluating the investigational therapy dapirolizumab pegol in people living with moderate-to-severe systemic lupus. Results of the Phase 3 PHOENYCS GO study were reported by study sponsors UCB and Biogen.

The initial topline results showed that compared with placebo, dapirolizumab pegol in addition to standard-of-care treatment met the primary endpoint, showing greater improvement at 48 weeks in moderate-to-severe disease activity as assessed by the widely accepted measurement tool called BICLA [British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA)]. This tool measures clinical disease activity based on patient medical history, clinical examination. and laboratory tests. Improvement was also seen in disease activity and flares. The safety profile of dapirolizumab pegol was consistent with that seen in previous studies.

“These results provide hope for people with lupus given the urgent need for additional treatment options to address the wide range of symptoms and complications caused by this highly heterogenous disease,” noted Stacie Bell, PhD, Executive Vice President of Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance. “We are particularly pleased to see these results, with Lupus Therapeutics having partnered with UCB and Biogen on the PHOENYC GO trial from start-up to reporting through the Lupus Clinical Investigators Network (LuCIN).”

Based on this trial, UCB and Biogen reported plans to initiate a second Phase 3 trial of dapirolizumab pegol, PHOENYCS FLY, in 2024. Lupus Therapeutics will continue to support the UCB/Biogen development program leveraging LT clinical expertise and LuCIN. The expansive, first-of-its-kind lupus clinical research network is comprised of more than 50 top clinical research institutions throughout North America.

Source: Sept. 24 UCB/Biogen Press Release

 

 

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