Manu Jaggi
Dabur Research Foundation, India
Title: Clinical development of a novel polyherbal product for treatment of atopic dermatitis and other chronic dermal inflammatory diseases
Biography
Biography: Manu Jaggi
Abstract
Atopic dermatitis (AD), also known as atopic eczema, is a type of inflammation of the skin (dermatitis). It results in itchy, red, swollen, and cracked skin. Current management strategies include oral medications, steroid creams and light therapy. We have developed a novel aqueous mixture (SIRB-001) consisting of three traditional Chinese medicine (TCM) based herbs; Rheum palmatum L. (Da Huang), Rehmannia glutinosa Libosch (Sheng di huang) and Lonicera Japonica (Jin yin hua) in the ratio 1:1:3. SIRB-001 based cream was developed and found to be highly safe in animal studies. SIRB-001 has previously demonstrated promising anti-psoriatic activity in pre-clinical models and clinical efficacy in psoriasis and scalp psoriasis. SIRB-001 exhibited anti-eczema properties in cell based models. Inhibition of cytokines and IgE was observed in keratinocytes (HaCaT)/immune cells and myeloma cell line-U-266, respectively. Inhibition of JAK-1/JAK-3 was induced by SIRB-001. Encouraging preclinical results paved the path for clinical investigations in atopic dermatitis. The efficacy, safety and tolerance of SIRB-001 cream were examined in 6-week clinical-dermatological application test in 25 subjects suffering from mild to moderate AD. With twice-daily application, SIRB-001 was very well tolerated and led to significant inhibition (p<0.001) in eczema area and severity index (EASI) with reduction of erythema, induration, excoriation and lichenification at 4 weeks and 6 weeks. Efficacious effect and tolerability of SIRB-001 cream was also evaluated in subjects with eczematous lesions in a mono-centric, open label study with twice daily application for 4 weeks. SIRB-001 cream demonstrated significant (p<0.001) decrease in eczema severity index (ESI), investigator's global assessment severity (IGAS) and was well-tolerated in human patients with a good safety profile. Inhibition of cytokines contributing to pathogenesis of AD; IL-8, IL-17A, TARC in serum samples was observed. It can be concluded that SIRB-001 is a highly effective new treatment with favorable safety profile for management of AD.