Connect Biopharma Holdings Limited (Nasdaq: CNTB) has announced the promising results of Stage 1 of its pivotal CBP-201 China trial in moderate-to-severe atopic dermatitis (AD). The study met its primary and secondary endpoints, showing rapid relief from symptoms as early as one week in some cases, with no efficacy plateau at Week 16. The majority of reported side effects were mild-to-moderate in nature.
These results were presented today as a late-breaking oral presentation at the American Academy of Dermatology Annual Meeting in New Orleans. Connect Biopharma is developing T cell-driven therapies to treat inflammatory diseases, making these results a potential breakthrough in the field.
The CBP-201-CN002 trial recently reported on the effectiveness of CBP-201, a next-generation IL-4Rα antibody, on the treatment of adults with moderate-to-severe atopic dermatitis in a 16-week Stage 1 pivotal trial in China. The trial included 255 patients who received a 600 mg loading dose, followed by 300 mg every two weeks, and compared to placebo.
Results showed rapid symptom relief, with a reduction in itch at Week 1 and significant improvement in all endpoints by Week 4, with the effects sustained until Week 16. Furthermore, the IGA and EASI efficacy response did not plateau at Week 16.
At 16 weeks, an impressive 30.3% of patients treated with CBP-201 achieved a score of 0-1 on the Investigators Global Assessment (IGA), meaning their skin was either clear or almost clear. This was significantly higher than the 7.5% of patients on placebo who achieved the same result, meeting the study’s primary endpoint.
An even bigger gap can be seen in skin clearance, with 62.9% of CBP-201 patients achieving a 75% skin clearance (EASI-75) versus 23.4% on placebo, and 35.8% achieving EASI-90 versus 6.3% of the placebo group. Not only that, but the PP-NRS reduction of 4 points was achieved by 35.0% of CBP-201 patients, compared to only 9.6% of the placebo group. With such positive results, it’s no surprise that CBP-201 was found to be well tolerated.
Connect Biopharma is proud to announce that data from their two CBP-201 atopic dermatitis studies is being presented at the esteemed American Academy of Dermatology Annual Meeting. This data shows rapid and sustained relief, with a highly differentiated profile that includes a higher binding affinity, higher potency, and slower target-mediated drug elimination.
With this, the potential for a more flexible 4-week dosing schedule becomes possible. As the unmet need for a moderate-to-severe atopic dermatitis treatment remains high, Connect Biopharma looks forward to the completion of their 36-week maintenance data from their CBP-201 China trial to develop this promising new treatment.
About Connect Biopharma Holdings Limited
Connect Biopharma is on a mission to improve the lives of millions of people suffering from chronic inflammatory diseases. The Company is harnessing its expertise in T cell biology and drug discovery industry to develop innovative therapies. Its lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) for the treatment of atopic dermatitis (AD) and asthma.
The second most advanced product, CBP-307, is a modulator of S1P1 T cell receptor designed to treat ulcerative colitis (UC). Lastly, CBP-174 is a peripherally acting antagonist of histamine receptor 3 in development for the treatment of pruritus associated with AD. Connect Biopharma is dedicated to bringing hope to those suffering from chronic inflammatory diseases.