CBP-201 shows favorable atopic dermatitis results in pivotal trial
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Key takeaways:
- 30.3% of patients with atopic dermatitis treated with CBP-201 achieved IGA 0 or 1 vs. 7.5% of placebo-treated patients.
- CBP-201 targets an interleukin-4Ralpha epitope and has a higher affinity than dupilumab.
NEW ORLEANS — A greater proportion of patients with atopic dermatitis experienced complete IGA improvement with CBP-201 vs. vehicle, according to a study presented at the American Academy of Dermatology Annual Meeting.
“CBP-201 is a next-generation monoclonal antibody that binds to a distinct [interleukin (IL)]-4Ralpha epitope with higher affinity than dupilumab, inhibiting the actions of IL-4 and IL-13,” Chin Lee, MD, MPH, of Connect Biopharma, said during the late breaker presentation.
Lee presented results from stage 1 of the randomized, double-blind, pivotal trial evaluating the efficacy of CBP-201 in adults with moderate to severe AD for 16 weeks. Stage 2, a maintenance treatment period of 36 weeks, is ongoing.
In stage 1, 255 patients were randomly assigned to receive CBP-201 300 mg (n = 170) or placebo (n = 85) once every 2 weeks. The treatment group also received a 600 mg CBP-201 loading dose on day 1.
Results showed that the study met the primary endpoint of a proportion of patients achieving IGA 0 or 1 and at least a 2-point decrease from baseline by week 16. A greater percentage of patients treated with CBP-201 achieved the endpoint vs. placebo (30.3% vs. 7.5%; P < .001).
The drug was also superior to vehicle in achieving EASI 75 responses with 62.9% of treated patients reaching the endpoint compared with 23.4% of the placebo group (P < .001). A higher proportion of patients treated with CBP-201 also achieved at least a 4-point reduction in Peak Pruritus Numerical Rating Scale scores vs. placebo (35% vs. 9.6%; P < .001).
Most treatment-emergent adverse events were mild or moderate and none led to treatment discontinuation.
“CBP-201 demonstrated efficacy in this study with a safety profile that was consistent with what we have seen before,” Lee concluded.