Kangnaide biomedical released innovative drug cbp-201 to treat moderate and severe atopic dermatitis

Data show that cbp-201 is more effective and more rapid after 4 weeks than the current research data of dupilumab On the 29th day, 42.9% (300mg dose group) and 50.0% (150mg dose group) of patients with moderate or severe atopic dermatitis received cbp-201 treatment achieved the investigator's overall assessment (IGA score) of 0 or 1, i.e complete or almost clear skin symptoms, which is also the end point for FDA approval, significantly higher than the level of 12.5% of placebo group Kangnaide biomedical is a biomedical 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 positive data of its new IL-4R α antibody cbp-201 (in Australia and New Zealand) for 1b clinical research of patients with moderate and severe atopic dermatitis Data show that cbp-201 is more effective and safe than the current standard biotherapy for atopic dermatitis The company expects to launch the 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, the company will participate in dozens of clinical trial centers in the United States and Europe, and will enroll more than 200 patients Atopic dermatitis is a chronic inflammatory skin disease characterized by eczema like skin lesions, pruritus, dry skin and sleep disorders, which has multiple negative effects on patients' lives Atopic dermatitis is a common disease It is estimated that 10-15% of children and 2-4% of adults suffer from atopic dermatitis Among them, about 30% of patients with atopic dermatitis are moderate to severe At present, there are still huge unmet medical needs in patients with moderate to severe atopic dermatitis who are difficult to fully control after topical corticosteroid treatment Dr Mike Royal, chief medical officer of Cornell, said: "although cbp-201 is still in the early stage of clinical development, the positive data of clinical trial 1b shows that cbp-201 can bring comprehensive improvement to patients with atopic dermatitis after only four weeks of treatment 42.9% (300mg dose group) and 50.0% (150mg dose group) of patients receiving cbp-201 will achieve the improvement after four weeks The skin symptoms were completely or almost cleared In contrast, the current standard biotherapy for atopic dermatitis has a placebo adjusted improvement rate of only 22-28% after 16 weeks of treatment The clinical effect of cbp-201 is very exciting! We will obtain more data in the 2B clinical study to further explore the important role of cbp-201 in the treatment of moderate to severe atopic dermatitis " Dr Zheng Wei, co-founder and CEO of Cornell, said: "we are very pleased to see that cbp-201 shows excellent tolerance and rapid efficacy in patients with moderate to severe atopic dermatitis after 4 weeks of treatment, and these data further support the potential of cbp-201 to have the best in class new drugs of the same kind In addition, the current standard biological treatment is 2-week administration, cbp-201 is expected to achieve better 4-week administration, which will make cbp-201 successful in clinical and commercial We look forward to further validating the positive results of the phase 1b trial in the phase 2B clinical study launched in the first quarter of 2020 " >>>>Key test results cbp-201 treatment can rapidly improve skin lesions in 29 days! This is based on the change of the overall assessment of the investigator (IGA) and the eczema area and severity index (EASI) from baseline ● 42.9% (300mg dose group) and 50.0% (150mg dose group) patients achieved the investigator's overall assessment (IGA score) of 0 or 1 point, i.e complete or almost clear skin symptoms, which is also the end point required by FDA approval, significantly higher than the level of 12.5% in placebo group ● 100% (300mg dose group) and 87.5% (150mg dose group) patients achieved easi score reduction of at least 50% (easi50) from baseline, compared with 37.5% in placebo group ● the easi scores in the 300mg and 150mg dose groups decreased by 74.4% and 74.0% on average compared with the baseline, compared with 32.9% in the placebo group ● the mean body surface area (BSA) in the 300mg and 150mg dose groups was 58.7% and 62.7% lower than that in the baseline, respectively, and 28.7% lower in the placebo group The skin lesions improved as soon as 1 week after administration, and the degree of improvement was related to the rapid reduction of itch intensity and frequency ● on day 15, the mean weekly pruritus numerical rating scale (PNRS) for the 300mg and 150mg dose groups was 40.4% and 26.4% lower than the baseline, respectively, compared with 3.5% for the placebo group ● on day 29, the mean weekly PNRS in the 300mg and 150mg dose groups decreased by 56.4% and 43.6% from baseline, respectively, compared with 20.6% in the placebo group ● on day 29, the mean weekly pruritus frequency decreased by 57.1% and 43.0% in the 300mg and 150mg dose groups, respectively, compared with 19.9% in the placebo group The results showed that cbp-201 was well tolerated ● there were no serious adverse events (SAE) and no injection site reactions or conjunctivitis / keratitis related adverse events ● 85.7% of the 300 mg group had at least one treatment emergent adverse event (teae) and 62.5% of the placebo group There was no correlation between the frequency and severity of teae and dosage ● most of the teaes were mild and mostly not related to cbp-201 ● the exacerbation of atopic dermatitis was the only teae in the study that resulted in the termination of the study, with one patient in the 75 mg dose group and one in the placebo group terminating the treatment >>>>About the clinical trial, the trial was a randomized, double-blind, placebo-controlled, multi dose incremental study in 31 patients with moderate to severe atopic dermatitis who were not effective in the treatment of local corticosteroids and immunosuppressants The treatment period was 4 weeks, so as to evaluate the safety and effectiveness of cbp-201 The trial was conducted in 10 clinical trial centers in Australia and New Zealand Ten patients in each dose group (75mg, 150mg or 300mg) were randomly assigned to cbp-201 or placebo treatment according to the ratio of 4:1 They were injected subcutaneously once a week for 4 weeks and followed up for 7 weeks The main clinical end point of the study was safety and tolerability of cbp-201 Other clinical end points included multiple effectiveness evaluation indexes (IGA score, easi score, lesion involved body surface area (BSA) and PNRS) >>>>Cbp-201 is a highly effective monoclonal antibody against IL-4R α IL-4R α is the 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 overlap significantly Cbp-201 is a new antibody drug independently developed by kangnaide biomedical through its unique immunomodulatory technology platform It is currently in the clinical development stage and is used to treat moderate and severe atopic dermatitis and other major Th2 inflammatory diseases that do not meet the clinical needs Previous phase 1A clinical studies in 48 healthy subjects showed that cbp-201 was well tolerated and could continuously and rapidly reduce thymic activation and regulatory chemokines (biomarkers of TARC / CCL17, Th2 activity) in serum >>>>About kangnaide biomedical kangnaide biomedical is a clinical stage biomedical company, focusing on the discovery and development of new immunomodulators for the treatment of autoimmune diseases and inflammation The company's unique immune regulation technology platform is based on T-cell functional biology Compared with traditional drug discovery methods, the high-throughput platform can more quickly and efficiently identify molecules targeting clinically proven disease pathways In addition to cbp-201, Conrad's other leading candidate drug cbp-307 is a new generation of S1P1 and S1P5 oral modulator, which is 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 showed good safety and high-efficiency T-cell regulatory activity, as well as ideal pharmacokinetic and pharmacodynamic characteristics, showing the potential of best in class Cbp-307 is currently undergoing two clinical phase 2 studies to evaluate its efficacy and safety in patients with moderate to severe ulcerative colitis and Crohn's disease Jeni turtle