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▎Editor of WuXi AppTec's content team On December 21, 2021, Eli Lilly and Company announced that the IL-13 inhibitor lebrikizumab and topical corticosteroid (TCS) are under investigation for the treatment of patients with moderate to severe atopic dermatitis.
The third pivotal phase 3 clinical trial, which reached all its primary and key secondary endpoints at week 16, proved that the lebrikizumab combination therapy group can significantly improve the severity of the patient's disease
.
The safety characteristics of the combination therapy are consistent with previous studies of lebrikizumab in the treatment of atopic dermatitis
.
The two previous clinical trials of the lebrikizumab project have also reached their primary endpoints.
Based on the positive data obtained, the company plans to submit a regulatory application next year
.
Atopic dermatitis, also known as eczema, is a chronic inflammatory skin disease caused by skin barrier dysfunction and immune response disorders
.
Usually patients will have strong and persistent itching symptoms, dry skin, skin inflammation, etc.
, and may affect sleep, daily activities and social relationships
.
In patients with atopic dermatitis, interleukin 13 (IL-13) protein is overexpressed, and by promoting type 2 helper T cell (Th2) response, it drives inflammation and leads to skin barrier dysfunction
.
Lebrikizumab is an innovative monoclonal antibody drug that can bind IL-13 with high affinity and specificity, thereby preventing the formation of IL-13Rα1/IL-4Rα complex and inhibiting the receptor complex-mediated Signal pathway
.
Prior to this, lebrikizumab has obtained fast-track qualifications granted by the US FDA to treat adults and adolescents with moderate to severe atopic dermatitis, and has obtained positive results in phase 2b clinical trials
.
▲The mechanism of action of Lebrikizumab and other antibody therapies targeting IL-4 and IL-13 signaling pathways (picture source: reference [2]) This randomized, double-blind, placebo-controlled phase 3 study aims to evaluate lebrikizumab combined with TCS therapy Efficacy and safety of adults and adolescents (age 12 to less than 18 years old, weight at least 40 kg) in patients with moderate to severe atopic dermatitis
.
In the study, TCS with or without topical calcineurin inhibitor (TCI) could not adequately control the patient's symptoms
.
The primary endpoint of the trial is the 16th week.
The Investigator’s Overall Assessment (IGA) score is clear (0) or almost clear (1) skin, and the eczema area and severity index (EASI) score is at least 2 points lower than the baseline.
Change from baseline by at least 75% (EASI 75)
.
In addition to reaching the primary endpoint of EASI 75, compared with placebo combined with TCS, the lebrikizumab combined with TCS treatment group also reached all key secondary endpoints, including skin improvement, relief of itching, improvement of sleep disturbance by itching, and quality of life
.
The most common adverse events (AE) in the Lebrikizumab combination therapy group included conjunctivitis and headache
.
The specific results will be announced at next year's scientific conference
.
"Considering the heterogeneity of the disease and the different outcomes of patients' signs and symptoms, doctors and patients who treat atopic dermatitis need new options that are different from the current standard treatment," Global Immunology Development and Eli Lilly's U.
S.
and Global Medical Affairs Vice President Dr.
Lotus Mallbris said, “These results add to the positive data of our lebrikizumab Phase 3 clinical trial project and support the hypothesis that targeting the IL-13 pathway is effective in treating atopic dermatitis and helping to improve the outcome of these patients.
Critical
.
We look forward to continuing to evaluate the clinical utility of lebrikizumab in ongoing trials to provide this drug to patients who still have unmet needs
.
"Reference: [1] Lilly's lebrikizumab demonstrated significant skin improvement and itch relief when combined with topical corticosteroids in people with atopic dermatitis in third Phase 3 study.
Retrieved December 12, 2021, from https://investor.
lilly.
com/news -releases/news-release-details/lillys-lebrikizumab-demonstrated-significant-skin-improvement[2] Moyle et al.
, (2019).
Understanding the immune landscape in atopic dermatitis: The era of biologics and emerging therapeutic approaches.
Experimental Dermatology, https://doi.
org/10.
1111/exd.
13911 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only.
The views in the article do not represent the position of WuXi AppTec, nor do they represent the position of WuXi AppTec.
It does not mean that WuXi AppTec supports or opposes the opinions
in the
article .
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital
.
The third pivotal phase 3 clinical trial, which reached all its primary and key secondary endpoints at week 16, proved that the lebrikizumab combination therapy group can significantly improve the severity of the patient's disease
.
The safety characteristics of the combination therapy are consistent with previous studies of lebrikizumab in the treatment of atopic dermatitis
.
The two previous clinical trials of the lebrikizumab project have also reached their primary endpoints.
Based on the positive data obtained, the company plans to submit a regulatory application next year
.
Atopic dermatitis, also known as eczema, is a chronic inflammatory skin disease caused by skin barrier dysfunction and immune response disorders
.
Usually patients will have strong and persistent itching symptoms, dry skin, skin inflammation, etc.
, and may affect sleep, daily activities and social relationships
.
In patients with atopic dermatitis, interleukin 13 (IL-13) protein is overexpressed, and by promoting type 2 helper T cell (Th2) response, it drives inflammation and leads to skin barrier dysfunction
.
Lebrikizumab is an innovative monoclonal antibody drug that can bind IL-13 with high affinity and specificity, thereby preventing the formation of IL-13Rα1/IL-4Rα complex and inhibiting the receptor complex-mediated Signal pathway
.
Prior to this, lebrikizumab has obtained fast-track qualifications granted by the US FDA to treat adults and adolescents with moderate to severe atopic dermatitis, and has obtained positive results in phase 2b clinical trials
.
▲The mechanism of action of Lebrikizumab and other antibody therapies targeting IL-4 and IL-13 signaling pathways (picture source: reference [2]) This randomized, double-blind, placebo-controlled phase 3 study aims to evaluate lebrikizumab combined with TCS therapy Efficacy and safety of adults and adolescents (age 12 to less than 18 years old, weight at least 40 kg) in patients with moderate to severe atopic dermatitis
.
In the study, TCS with or without topical calcineurin inhibitor (TCI) could not adequately control the patient's symptoms
.
The primary endpoint of the trial is the 16th week.
The Investigator’s Overall Assessment (IGA) score is clear (0) or almost clear (1) skin, and the eczema area and severity index (EASI) score is at least 2 points lower than the baseline.
Change from baseline by at least 75% (EASI 75)
.
In addition to reaching the primary endpoint of EASI 75, compared with placebo combined with TCS, the lebrikizumab combined with TCS treatment group also reached all key secondary endpoints, including skin improvement, relief of itching, improvement of sleep disturbance by itching, and quality of life
.
The most common adverse events (AE) in the Lebrikizumab combination therapy group included conjunctivitis and headache
.
The specific results will be announced at next year's scientific conference
.
"Considering the heterogeneity of the disease and the different outcomes of patients' signs and symptoms, doctors and patients who treat atopic dermatitis need new options that are different from the current standard treatment," Global Immunology Development and Eli Lilly's U.
S.
and Global Medical Affairs Vice President Dr.
Lotus Mallbris said, “These results add to the positive data of our lebrikizumab Phase 3 clinical trial project and support the hypothesis that targeting the IL-13 pathway is effective in treating atopic dermatitis and helping to improve the outcome of these patients.
Critical
.
We look forward to continuing to evaluate the clinical utility of lebrikizumab in ongoing trials to provide this drug to patients who still have unmet needs
.
"Reference: [1] Lilly's lebrikizumab demonstrated significant skin improvement and itch relief when combined with topical corticosteroids in people with atopic dermatitis in third Phase 3 study.
Retrieved December 12, 2021, from https://investor.
lilly.
com/news -releases/news-release-details/lillys-lebrikizumab-demonstrated-significant-skin-improvement[2] Moyle et al.
, (2019).
Understanding the immune landscape in atopic dermatitis: The era of biologics and emerging therapeutic approaches.
Experimental Dermatology, https://doi.
org/10.
1111/exd.
13911 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only.
The views in the article do not represent the position of WuXi AppTec, nor do they represent the position of WuXi AppTec.
It does not mean that WuXi AppTec supports or opposes the opinions
in the
article .
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital
.
