DS Biopharma announces positive top-line phase 2b trial results for DS107 as a topical treatment for mild to moderate atopic dermatitis
Dublin, Ireland, October 3rd 2018 – DS Biopharma (DS), a privately held biopharmaceutical company, today announced positive top line results from a phase 2b clinical trial of topical DS107 (called ‘ADvantage’) in 326 mild to moderate atopic dermatitis (AD) patients.
DS107 is a novel, immunomodulating, bioactive lipid which targets the immune activation and skin barrier dysfunction of AD by inhibiting the expression of CD40. Inhibition of CD40 in AD patients downregulates T-cell activation and downstream Th2, Th1, Th17 and Th22 cytokine production.
The ADvantage trial was an international (mainly North America), randomized, double-blind, multi-centre, vehicle-controlled phase 2b study over 8 weeks of treatment, followed by a 2 week follow-up period where the efficacy and safety of DS107 cream (1% and 5%) were evaluated. Efficacy of DS107 was assessed by the key regulatory endpoints for AD; Investigator’s Global Assessment (IGA) which is at least a 2-grade improvement from baseline with a score of clear or almost clear and Eczema Area and Severity Index (EASI).
The results showed a clear dose dependent response in IGA and EASI-75 (proportion of patients who showed a 75% reduction of the EASI score compared to baseline value). For 5% Topical DS107 both IGA and EASI-75 approached statistical significance at the end of the treatment period and were statistically significant after the two week follow-up period compared to vehicle (p=0.029 and p=0.019 respectively). There was no evidence of reaching a treatment plateau after the 8 week treatment period and also the follow-up period in both the IGA and EASI scores for the 5% DS107 cream. A clinically meaningful mean change from baseline of 2.9 points with 5% DS107 was also achieved for pruritus as measured by the Numerical Rating Scale (NRS).
DS107 cream at doses of 1% and 5% was safe and very well tolerated. There were no trends in Adverse Event (AE) incidence rates, no differences in the safety profile between active treatment and vehicle cream and no drug-related Serious Adverse Events (SAEs). The ADvantage results have been accepted for an oral presentation at the next Inflammatory Skin Disease Summit being held in Vienna, Austria during the 12th-15th of December 2018.
Commenting on the results, DS Biopharma Chief Operating Officer, Dr. Markus Weissbach, M.D., Ph.D. said: “The Company welcomes the positive top-line results of this study which show that DS107 cream, with its excellent safety profile, is an effective topical treatment for mild to moderate atopic dermatitis. The product is now a Phase 3 ready asset with a novel mechanism of action that has the potential to change the treatment paradigm of atopic dermatitis. Further data on Topical DS107 have shown encouraging steroid sparing potential in an exploratory study which will be further investigated.”
Prof. Emma Guttman-Yassky, M.D., Ph.D., Professor of Dermatology and Immunology, Icahn School of Medicine at Mount Sinai and DS Biopharma scientific advisory board member further commented: “DS107 is an immunomodulator with a novel mechanism of action targeting CD40 that may offer a safe and effective alternative to current treatment options.”
About DS Biopharma
DS Biopharma (DS), headquartered in Dublin, Ireland, is a privately held, clinical stage, pharmaceutical drug discovery and development company, which develops new medicines for unmet needs in dermatological diseases. The compounds under development are based on a novel bioactive lipid platform. These lipid molecules have been shown to be crucial to the pathways of several conditions including skin disorders such as atopic dermatitis (AD). The Company’s lead compound; DS107 is being explored clinically as both a topical cream for mild to moderate AD and separately as an oral capsule in moderate to severe AD. DS holds multiple patents and pending patent applications protecting the DS107 product and its clinical uses.