IQVIA gets CDSCO panel nod to conduct study of ASLAN004 for atopic dermatitis
New Delhi: Drug maker IQVIA has got approval from the Central Drugs Standard Control Organization (CDSCO) to conduct a Phase IIb clinical trial of monoclonal antibody ASLAN004 for triggering symptoms of allergy in atopic dermatitis.
This came in line with the protocol presented by the firm for the Phase IIb clinical trial for monoclonal antibody ASLAN004 for triggering symptoms of allergy in atopic dermatitis.
Atopic Dermatitis (AD) is a chronic, inflammatory skin condition that severely impacts the quality of life for millions of children and adults globally. ASLAN004 is the only IL-13Rα1 receptor in clinical development for the treatment of AD.
ASLAN004 is a novel, first-in-class monoclonal antibody that targets the IL-13 receptor α1 subunit (IL-13Rα1), one of the components of the Type 2 receptor.
By blocking the Type 2 receptor, ASLAN004 prevents signaling through both interleukin 4 (IL-4) and interleukin 13 (IL-13), the key drivers of inflammation, which are central to triggering symptoms of allergy in atopic dermatitis, such as redness and itching of the skin, and in other atopic diseases.
This unique action of blocking the IL-13 receptor rather than the IL-4 receptor has the potential for improved efficacy, safety, and dose regimen. ASLAN004 is found to be safe and efficacious in treating moderate-to-severe atopic dermatitis.
At the 67th SEC meeting for Dermatology & Allergy held on March 15th, 2022, the committee extensively reviewed the protocol presented by IQVIA for conducting a Phase IIb clinical trial for monoclonal antibody ASLAN004 for triggering symptoms of allergy in atopic dermatitis.
After detailed deliberation, the committee recommended the grant of permission to conduct the study as per the protocol presented.
