Clinical Study Shows Topical DS107 Prevents Disease Exacerbation in Atopic Dermatitis Patients

DS Biopharma announces DS107 patent grant in the US for the treatment of atopic dermatitis
November 19, 2018
Show all

Clinical Study Shows Topical DS107 Prevents Disease Exacerbation in Atopic Dermatitis Patients

Dublin, Ireland, March 06 2019 – DS Biopharma (DS) today announced positive results from a new study where continued treatment with 5% DS107 cream not only maintained the treatment response after 1 week topical corticosteroid (TCS) application but also further improved signs and symptoms of atopic dermatitis (AD) after the steroid treatment was discontinued.

In a randomized, double-blind, vehicle-controlled, multicentre study in moderate to severe AD patients, the effects of 5% DS107 cream were assessed using the standard efficacy endpoints for AD including; Investigator’s Global Assessment (IGA), Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD) and body surface area affected by AD (BSA).

Once treatment with TCS (1% Mometasone Furoate Cream) was withdrawn after day 7, the 5% DS107 cream maintained and incrementally improved clinically meaningful responses for the remaining treatment period of 4 weeks. This effect was over and above that seen with the vehicle across multiple endpoints (IGA, EASI, SCORAD and BSA). The treatment effect increased further during a 1 week follow-up period and reached statistically significant differences in favour of the DS107 group for IGA and Objective SCORAD.

 
DS107 cream was safe and well tolerated. There were no study drug-related serious adverse events or notable differences between the treatment groups.

Commenting on the results, Prof. Diamant Thaci, M.D., Principal Investigator and Key Opinion Leader, Professor of Dermatology and Head of the Comprehensive Center for Inflammation Medicine, University of Lubeck, Germany stated:

 
 “I am very encouraged by the positive results seen in this study, the design of which mirrors daily clinical practice. These results suggest that DS107 cream has a potential pharmacological role in preventing exacerbation following the application of topical corticosteroids. A safe and effective topical cream which reduces the frequency of flares will be an important addition to the treatment options for dermatologists and patients alike”.

Commenting on the results, DS Biopharma Chief Operating Officer, Dr. Markus Weissbach, M.D., Ph.D. said “The Company is very pleased that in such a short study, statistically significant differences in key parameters like IGA and Objective SCORAD were observed. These results further support the utility of topical DS107 which is Phase 3 ready.”

About DS Biopharma
DS Biopharma (DS), headquartered in Dublin, Ireland, is a 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 (Phase 3) and separately as an oral capsule in moderate to severe AD (Phase 2). DS107 is a novel, immunomodulating, bioactive lipid which targets the immune activation and skin barrier dysfunction of AD by inhibiting the expression of CD40. DS holds multiple patents and pending applications protecting the DS107 product and its clinical uses.

Contact DS Biopharma: investorrelations@dsbiopharma.com, +35312933590