UCB and Biogen’s lupus drug has met its primary endpoint in a Phase III trial, but the companies are yet to release the study data.
The PHOENYCS GO study (NCT04294667) evaluated dapirolizumab pegol on top of standard of care (SOC) in 321 patients with moderate-to-severe systemic lupus erythematosus (SLE).
The trial met the primary endpoint of demonstrating greater improvement of moderate-to-severe disease activity as assessed by achievement of the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) after 48 weeks.
The drug also showed clinical improvements among secondary endpoints measuring disease activity and flares. The safety profile was generally consistent with previous studies.
Following the announcement, UCB’s stock rose slightly (2.57%) from a close of €163.40 on 23 September to an open of €167.60 on 24 September. The NASDAQ stock market, where Biogen is listed, had not yet opened at the time of publication.
An earlier Phase II trial of the drug failed to meet its primary endpoint. Despite this, the companies decided to run a Phase III trial of the candidate, a decision which appears to have paid off.
The companies have not announced specifics of the Phase III data but said they will be presented at an upcoming medical conference.
Following the announcement, the companies will run another Phase III trial, PHOENYCS FLY, which will begin before the end of the year. All patients from the PHOENYCS GO study will be enrolled on an open-label study.
Head of patient evidence at UCB, Fiona du Monceau said: “These positive results with dapirolizumab pegol represent encouraging progress in the development of medicines that can improve the lives of those living with lupus, an area that remains one of high unmet medical need and where women are disproportionately affected.”
Dapirolizumab pegol is a humanised anti-CD40L antibody that acts by inhibiting the activation of cells bearing CD40 on their cell surface by CD40 ligand, which plays a vital role in T cell activation and the manufacturing of antibodies by B cells.
SLE is an autoimmune disease where the immune system of the body mistakenly attacks healthy tissue.
In March 2023, AbbVie reported data from a Phase II trial of its SLE candidate upadacitinib.
