Ucb and Biogen (BIIB.US) announced on Monday that their investigational drug dapirolizumab pegol (DZP) has met the primary endpoint in a Phase 3 clinical trial for the treatment of systemic lupus erythematosus.
Trial data showed that 50% of patients in the treatment group achieved a BICLA response at week 48, compared to 35% in the placebo group, with the difference being statistically significant.
Dapirolizumab pegol is a novel, investigational antibody fragment (Fab) targeting CD40 ligand (CD40L, also known as CD154) and conjugated with polyethylene glycol (PEG).
This trial was conducted in patients with moderate to severe active systemic lupus erythematosus (SLE).
BICLA is a composite efficacy endpoint used to assess whether patients experience a clinically meaningful improvement in disease activity across all affected organ systems, without worsening of other lupus-related conditions.
A higher BICLA response rate indicates a more ideal treatment effect and signifies that patients can obtain clinical benefit.
As the first key secondary endpoint (BICLA response at week 24) was not met, subsequent results were not adjusted for multiplicity.
Overall, across multiple assessment measures, DZP combined with standard of care (SOC) demonstrated positive efficacy, including in severe BILAG flare, SRI-4, SLEDAI-2K, and skin and joint-related measures.
Regarding safety, the incidence of serious adverse events for the drug was 10%, lower than the 14.8% in the placebo group.
Patient recruitment is currently underway for the confirmatory Phase 3 'PHOENYCS FLY' trial.
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