Connect Biopharma has reported 52-week improvements across multiple endpoints in a phase 3 trial of its eczema drug candidate, fueling the biotech’s belief that its molecule is better than Dupixent.
Simcere Pharmaceutical, Connect’s partner, enrolled 259 adolescent and adult patients with moderate to severe atopic dermatitis at sites in China. After a 16-week induction stage, participants randomized to the study drug, rademikibart, continued on the IL-4/IL-13 blocker for another 36 weeks. Patients randomized to placebo switched to rademikibart.
At Week 52, 96.6% of patients had a 75% or greater reduction from baseline in their Eczema Area and Severity Index (EASI) score. More than 85% of patients had a 90% or greater improvement in EASI, and 87.1% of people had clear or almost clear skin on the Investigator’s Global Assessment (IGA).
Sanofi and Regeneron generated 52-week monotherapy results for their blockbuster IL-4/IL-13 blocker Dupixent by rerandomizing patients who met the EASI-75 or IGA 0/1 endpoints at Week 16. The design differences complicate cross-trial comparisons. Sanofi and Regeneron reported 52-week rates of EASI-75 and IGA 0/1 of 64% and 40%, respectively, in a study that tested weekly Dupixent plus topical steroids.
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On a call with investors to discuss the data, Connect CEO Barry Quart named the rate of conjunctivitis, an eye condition, as a differentiator versus Dupixent. The rates for rademikibart were 3.9% at Week 16 and 6.3% at Week 52, compared to 3.1% and 5.6%, respectively, on placebo. In comparison, the rate of conjunctivitis in the phase 3 monotherapy Dupixent trials was (PDF) 10%.
Quart said the conjunctivitis rate on rademikibart was “substantially lower than was seen with other products.” The CEO compared rademikibart to Apogee Therapeutics’ zumilokibart, noting that the rival biotech recently reported a 20.2% rate of conjunctivitis at Week 52.
Connect shared Simcere’s phase 3 eczema results alongside phase 1 data on rademikibart in asthma and chronic obstructive pulmonary disease. Quart compared the data favorably to the results on Dupixent, while noting that the rademikibart results come from a small trial.
The respiratory diseases are Connect’s focus, with Quart reiterating the biotech’s decision not to expend its resources on atopic dermatitis. While Connect is awaiting more asthma data, Quart said the biotech plans to start phase 3 studies in acute and chronic forms of the respiratory disease early next year. Connect wants to find a commercial partner to share the costs of the phase 3 program.
