Oral DS107 found to reverse the molecular signature of moderate to severe atopic dermatitis patients in a phase 2 trial

DS Biopharma announces positive top-line phase 2b trial results for DS107 as a topical treatment for mild to moderate atopic dermatitis
October 3, 2018
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Oral DS107 found to reverse the molecular signature of moderate to severe atopic dermatitis patients in a phase 2 trial

Dublin, Ireland, October 18th 2018 – DS Biopharma (DS), a privately held biopharmaceutical company, today announced that oral treatment with DS107 reversed the molecular signature of Atopic Dermatitis (AD) patients in a phase 2b clinical trial comprising 319 patients with moderate to severe AD (ADvance Study).

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 downregulates T-cell activation and downstream Th2, Th17, Th1 and Th22 cytokine production. As activated T-cells play a role in triggering and sustaining AD, this mechanism of action suggests that DS107 has potential utility as a disease modifying agent in this disease.

The ADvance trial was an international (predominately US), randomized, double-blind, multi-centre, placebo-controlled phase 2b study over 8 weeks of treatment where the efficacy and safety of oral DS107 administered in capsules in once daily doses of 1g and 2g, were evaluated. The participating patients were 86% moderate and 14% severe.

As part of the study procedures, serum samples were taken from all patients pre and post treatment. These blood samples were analysed to evaluate the key inflammation and immune response biomarkers associated with AD.

The biomarker results showed statistically significant reversals in the proteomic profile of AD patients who received 2g DS107 after 8 weeks of treatment contrasting with little or no change in patients administered with 1g DS107 or placebo.  The treatment with the 2g DS107 dose improved the proteomic AD profile significantly decreasing the expression of 99 upregulated proteins. This includes statistically significant reductions in a number of key cytokines from downstream pathways targeted by other AD therapies including Th2 (OSM, IL5-RA, IL-13), Th17 (IL-17A) and Th1 (IL-12, IL-18). In addition, 2g DS107 was shown to have a statistically significant impact on key fibrotic markers (TGF-β, EGFR, VEGF-A, HGF).

Oral treatment with DS107 was safe and very well tolerated in the ADvance study without any drug-related Serious Adverse Events (SAEs). The ADvance results have been accepted for presentation at the next Inflammatory Skin Disease Summit being held in Vienna, Austria from the 12th-15th of December 2018 where full detail of the results will be available.

Commenting on the  data, Prof. Emma Guttman-Yassky, MD PhD, Professor of Dermatology and Immunology, Icahn School of Medicine at Mount Sinai and DS Biopharma scientific advisory board member said: “DS107 is an oral molecule with a novel mechanism of action which has significantly impacted AD biomarkers in serum and has the potential to offer a safe and effective oral therapy for Atopic Dermatitis.”

DS Biopharma Chief Operating Officer, Dr. Markus Weissbach MD PhD said: “The Company is very encouraged by the DS107 biomarker data which is the first time we have observed such a significant reversal in the molecular signature of Atopic Dermatitis. DS107 could potentially be a disease modifying therapy and these results further support the recent positive topical DS107 phase 2b data. We look forward to sharing detailed clinical data on oral DS107 at the Inflammatory Skin Disease Summit in December. The additional finding that DS107 downregulates a number of fibrosis biomarkers also expands the potential of DS107 in other indications such as scleroderma.”

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 (phase 3 ready) and separately as an oral capsule in moderate to severe AD (phase 2b). DS holds multiple patents and pending applications protecting the DS107 product and its clinical uses.

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