The data show that compared with the current research data of standard biological treatment of moderate to severe atopic dermatitis (Dupilumab), CBP-201 has a better effect after 4 weeks of treatment and has a more rapid onset of action.
On day 29, of the patients with moderate to severe atopic dermatitis treated with CBP-201, 42.9% (300mg dose group) and 50.0% (150mg dose group) achieved the investigator’s overall assessment (IGA score) of 0 or 1 That the skin symptoms are completely or almost cleared, which is also the study endpoint required for FDA approval, is significantly higher than the 12.5% level in the placebo group.
Connectbiopharm is a biopharmaceutical company that focuses on the development of new drugs for the treatment of autoimmune diseases and has clinical-stage products. On January 8, 2020, it released its new IL-4Rα antibody CBP-201 (in Australia and New Zealand) targeting moderate-to-severe Positive data from clinical studies of patients with atopic dermatitis 1b. The data show that compared with the current research data of atopic dermatitis standard biotherapy, CBP-201 has better efficacy and safety after 4 weeks of treatment. The company expects to start a global 2b clinical study of CBP-201 in the treatment of moderate to severe atopic dermatitis in the first quarter of 2020. At that time, it will participate in dozens of clinical trial centers including the United States and Europe and will enroll more than 200 patients.
Atopic dermatitis is a chronic inflammatory skin disease characterized by skin eczema-like lesions, itching, dry skin, and sleep disturbances, which has multiple negative effects on patients’ lives. Atopic dermatitis is a common disease and it is estimated that 10-15% of children and 2-4% of adults have atopic dermatitis. Among them, about 30% of patients with atopic dermatitis are moderate to severe patients. There are still huge unmet medical needs in patients with moderate to severe atopic dermatitis that are difficult to adequately control after topical corticosteroid treatment.
“Although CBP-201 is still in the early stages of clinical development, positive data from the 1b clinical trial shows that CBP-201 can bring atopic dermatitis to patients with atopic dermatitis in just 4 weeks Overall improvement, 42.9% (300mg dose group) and 50.0% (150mg dose group) of patients treated with CBP-201 achieved complete or almost clear skin symptoms after 4 weeks. Now, after 16 weeks of treatment with atopic dermatitis standard biotherapy, the improvement rate after placebo adjustment is only 22-28%. The clinical effect of CBP-201 is very exciting! We will be in 2b More data will be obtained in clinical studies to further explore the important role of CBP-201 in the treatment of moderate to severe atopic dermatitis. ”
“We are very pleased to see that CBP-201 shows excellent tolerance and rapid onset of action after 4 weeks of treatment in patients with moderate to severe atopic dermatitis, and these data further support CBP-201 has the potential of best-in-class new drugs. In addition, the current standard biological treatment is once every two weeks, and CBP-201 is expected to achieve a better four-week once-administration, which will make CBP-201 is clinically and commercially successful. We look forward to further validating the positive results of the Phase 1b trial in a Phase 2b clinical study initiated in the first quarter of 2020. ”
Key test results
CBP-201 treatment can quickly improve skin lesions in 29 days! This is based on changes in the investigator’s overall assessment (IGA) and eczema area and severity index (EASI) from baseline.
● 42.9% (300mg dose group) and 50.0% (150mg dose group) of patients achieved the investigator’s overall assessment (IGA score) of 0 or 1, which means that the skin symptoms are completely or almost cleared, which is also required by FDA approval. The study endpoint was significantly higher than the 12.5% level in the placebo group.
● 100% (300mg dose group) and 87.5% (150mg dose group) patients achieved an EASI score reduction of at least 50% (EASI50) from baseline, compared with 37.5% in the placebo group.
● The average EASI scores of the 300 mg and 150 mg dose groups were 74.4% and 74.0% lower than baseline, compared with 32.9% in the placebo group.
● The average atopic dermatitis affected body surface area (BSA) in the 300 mg and 150 mg dose groups was reduced by 58.7% and 62.7% from baseline, respectively, and the placebo group was reduced by 28.7% on average.
Skin lesions improved as soon as 1 week after administration, and the degree of improvement was related to the rapid decrease in itching intensity and frequency.
● At day 15, the average weekly pruritus digital score scale (PNRS) for the 300 mg and 150 mg dose groups was 40.4% and 26.4% lower than the baseline, and 3.5% for the placebo group.
● On day 29, the average weekly PNRS in the 300 mg and 150 mg dose groups was 56.4% and 43.6% lower than baseline, respectively, compared to 20.6% in the placebo group.
● On day 29, the average weekly itching frequency in the 300 mg and 150 mg dose groups decreased by 57.1% and 43.0%, respectively, compared to 19.9% in the placebo group.
The results show that CBP-201 is well tolerated.
● No serious adverse events (SAE), and no injection site reactions or adverse events related to conjunctivitis / keratitis.
• The proportion of patients who experienced at least one adverse event (TEAE) in the 300 mg dose group was 85.7%, compared with 62.5% in the placebo group. The frequency and severity of TEAE were not related to the dose.
● Most TEAEs are mild and most are not related to CBP-201.
Aggravation of atopic dermatitis was the only TEAE in the study that resulted in the discontinuation of study treatment. One patient in the 75 mg dose group and one in the placebo group discontinued treatment.
About clinical trials
The trial was a randomized, double-blind, placebo-controlled, multi-dose escalation study in 31 patients with moderate to severe atopic dermatitis who did not respond well to topical corticosteroids and immunosuppressive agents. The treatment period was 4 weeks. Assess the safety and effectiveness of CBP-201. The trial was conducted at 10 clinical trial centres in Australia and New Zealand. Ten patients in each dose group (75 mg, 150 mg, or 300 mg) were randomly assigned to CBP-201 or placebo in a 4: 1 ratio, administered subcutaneously once a week for 4 weeks, Followed up for 7 weeks. The primary clinical endpoint of the study was the safety and tolerability of CBP-201. Other clinical endpoints included multiple efficacy assessment indicators (IGA score, EASI score, lesion involvement body surface area (BSA), and PNRS).
CBP-201 is a highly potent anti-IL-4Rα monoclonal antibody. IL-4Rα is a cell surface protein required for IL-4 and IL-13 signaling. IL-4 and IL-13 are two key Th2 proinflammatory cytokines, and their biological activities significantly overlap. CBP-201 is a new antibody drug independently developed by Connectbiopharm through its unique immunomodulation technology platform. It is currently in clinical development and is used to treat moderate to severe atopic dermatitis and other major Th2 inflammatory diseases that do not meet clinical needs. Previous Phase 1a clinical studies in 48 healthy subjects have shown that CBP-201 is well tolerated and enables serum thymus activation and regulation of chemokine (TARC / CCL17, a biomarker of Th2 activity) Material) continued to decrease rapidly.
Connectbiopharm is a clinical stage biopharmaceutical company focused on the discovery and development of new immunomodulators for the treatment of autoimmune diseases and inflammation. The company’s unique immunomodulation technology platform is based on the functional biology of T cells. Compared with traditional drug discovery methods, the high-throughput platform can more quickly and efficiently identify molecules that target clinically proven disease pathways. .
In addition to CBP-201, Conrad’s other leading drug candidate, CBP-307, is a new generation of S1P1 and S1P5 oral modulators that are expected to be used to treat a variety of autoimmune diseases, including inflammatory bowel disease, psoriasis, and multiple Sclerosis. In two completed clinical phase 1 randomized, double-blind, placebo-controlled studies, CBP-307 has shown good safety and efficient T cell regulatory activity, as well as ideal pharmacokinetics and pharmacodynamic characteristics, Shows the potential of best-in-class. CBP-307 is currently undergoing two Phase 2 clinical studies to evaluate its efficacy and safety in patients with moderate to severe ulcerative colitis and moderate to severe Crohn’s disease.