UCB and Biogen’s Phase III PHOENYCS GO trial results signal a pivotal development for systemic lupus erythematosus (SLE) treatment, as dapirolizumab pegol met its primary endpoint and demonstrated enhanced disease control and safety at Week 48. With a novel CD40L-targeting mechanism and favourable efficacy outcomes, this therapy has the potential to challenge established SLE treatments and address unmet needs in an increasingly competitive therapeutic landscape, according to GlobalData.
The findings of this trial constitute a significant milestone for the companies. They will debut as a late-breaking abstract at the upcoming American College of Rheumatology (ACR) 2024 congress, which will take place from November 14 to 19, 2024.
In PHOENYCS GO, dapirolizumab pegol achieved the primary endpoint of achieving a BILAG 2004-based Composite Lupus Assessment (BICLA) response at Week 48. This was coupled with improvements in key secondary measures of disease activity and a consistent safety profile. This data will reinforce stakeholder confidence in the asset’s potential as an effective therapy for SLE, as well as its ability to compete with established SLE treatments.
Kieran Walker, Immunology Analyst at GlobalData, comments, “The SLE market is currently dominated by GSK and AstraZeneca and their established products, Benlysta and Saphnelo, respectively, with no new advanced therapies having been approved since 2021 in the US and 2022 in the EU.
With the announcement of positive Phase III data, dapirolizumab pegol is set to attract renewed interest following disappointing Phase IIb results, where it failed to meet its primary endpoint of a BICLA response. To justify progression to Phase III development, the PHOENYCS GO trial included updated eligibility criteria, informed by a post-hoc analysis of the Phase IIb study. Based on this, patients were selected with moderate-to-severe disease activity due to persisting active SLE or an acute worsening of SLE.
Walker continues, “The SLE development pipeline is highly active, with several promising therapies poised to enter the lupus market. AbbVie’s upadacitinib, BMS’s deucravacitnib, and Biogen’s own litifilimab are also in late-stage development. UCB and Biogen will likely leverage dapirolizumab’s unique CD40L-targeting MoA, a distinction that, according to the key opinion leaders interviewed by GlobalData, holds significant relevance for addressing the pathophysiology of lupus as a key driver of dysregulated immune responses.
However, UCB and Biogen are set to face strong competition within the adolescent SLE segment, particularly from Novartis’ ianalumab and RemeGen’s telitacicept, whose Phase III trials span the full adolescent age range, while dapirolizumab’s Phase III studies focus on patients ages 16 and older.
According to GlobalData, dapirolizumab pegol sales are expected to reach $63.4 million by 2031, assuming the asset attains approval in 2028.
Walker concludes: “The upcoming presentation of the PHOENYCS GO results will reignite interest in dapirolizumab pegol in SLE and, riding on this success, the companies are moving forward with a second Phase III study, PHOENYCS FLY. Additionally, patients who completed PHOENYCS GO will continue to be assessed in a long-term open-label study, underscoring both companies’ commitment to understanding the sustained benefits and safety profile of dapirolizumab pegol.”
Edits made by EP News Bureau