UCB has announced the initiation of a Phase III clinical trial evaluating the efficacy and safety of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SoC) medication. Key opinion leaders interviewed by leading data and analytics company GlobalData noted that although DZP was not entirely successful in its Phase II trial it is still possible to attain success - as evidenced by the fact that GlaxoSmithKline’s (GSK’s) Benlysta (belimumab) also did not do well in its Phase II trial.
GlobalData forecasts that DZP will enter the market in 2024 and will be the third subcutaneous (SC) biologic launched after GSK’s Benlysta and Janssen’s Stelara (ustekinuma). This will hamper DZP’s uptake especially if Stelara shows better efficacy than DZP. It is essential that UCB prices DZP effectively as the drug will have the potential to overtake both Stelara and Benlysta in sales if it can be priced at a discount especially compared to Stelara’s annual price of over $100000 per patient in the US.
Patrick Aiyes Senior Immunology Analyst at GlobalData comments: “The intention is to achieve clinically relevant long-term improvement in moderate-to-severe systemic lupus erythematosus (SLE) despite the fact that DZP failed to meet its primary endpoint in its Phase IIb trial. In view of DZP’s Phase IIb failures it will be interesting to evaluate whether the therapy can be a success in SLE.”
The randomized double-blind placebo-controlled Phase III study will enroll approximately 450 SLE patients. The estimated primary completion date of the study is October 2022 with overall study completion anticipated in November 2022.
Aiyes adds: “In the Phase IIb study evaluating efficacy and safety DZP did not meet its primary endpoint of demonstrating a dose response on the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA).
“Despite its flaws DZP’s BICLA response rates at Week 24 for the 6mg/kg 24mg/kg and 45mg/kg doses were 48.8% 54.5% and 52.5% compared to 37.2% with placebo. Janssen’s Stelara (ustekinumab) also measured BICLA response as a secondary endpoint in its LOTUS Phase II study and its results versus placebo at Week 24 were 35% versus 33% respectively. From the indirect comparisons with Phase II SLE trials for DZP and Stelara all doses of DZP seem to induce a higher rate of BICLA response at Week 24.”