Delenex Therapeutics Release: New Clinical Data Show Biologic Activity Of DLX105 Upon Topical Application Onto Psoriatic Skin

– Presentation of data at the 44th Annual ESDR Meeting in Copenhagen, Denmark
– Data enable pipeline of topically applied PENTRA®Bodies for various dermatological diseases

Schlieren/Zurich, September 11, 2014 - Delenex Therapeutics AG, a clinical stage biopharmaceutical company primarily developing treatments for dermatological diseases using its proprietary PENTRA®Bodies, today announced new clinical data of its lead program DLX105. It is a PENTRA®Body targeting TNF? for the treatment of mild to moderate psoriasis and hidradenitis suppurativa. The data were presented at this year’s European Society for Dermatological Research Meeting in Copenhagen (Poster LB011).

In a double-blind, parallel-group, placebo-controlled phase 2 study involving 59 patients with mild to moderate plaque psoriasis, patients were randomly assigned in a 1:1 manner to twice daily topical treatment with DLX105 or placebo for 4 weeks.

Gene expression data in skin biopsies taken at Day 14 demonstrated a DLX105-mediated highly significant reduction of TNF? and the TH17 pathway as compared to placebo. Levels of TNF?-dependent cytokine genes such as IL-1ß, IL-6, IL-8, IL-12, IL-17, IL-22, IL-23 and IL-27 were also decreased. “The changes in expression of relevant biomarkers show biological activity of DLX105 upon topical administration onto the skin of psoriasis patients,” said Georg Stingl, MD, together with Thomas Luger, MD, and Martin Röcken, MD, investigator of this clinical trial. “As the applied dose of DLX105 reduced markers of skin inflammation without causing significant clinical improvement, we expect to see clinical activity and an impact on PASI score with longer treatment periods, as is the case for etanercept, with increased drug concentrations in the skin or with our more potent follow-on drug DLX2751,” commented Thomas Jung, MD, Chief Medical Officer at Delenex. Treatment was very well tolerated and did not result in any measurable levels of DLX105 in patients’ blood, providing the basis for a superior safety profile compared to systemically administered anti-TNF? antibodies.

“The data demonstrate a first proof-of-principle for the penetration of our small and highly potent PENTRA®Bodies into the skin of patients,” adds Thomas Hecht, MD, Executive Chairman of Delenex. “These data are an encouraging, important step forward and validate our pipeline of proprietary PENTRA®Bodies for the topical treatment of various dermatological diseases.”

About Delenex Therapeutics AG

Delenex is a privately-held, clinical stage biopharmaceutical company focused on the development of locally and systemically applied antibody therapeutics. Delenex aims at extending the benefits of proven antibody therapeutics to a much larger number of people suffering from psoriasis, hidradenitis suppurativa, acne and other, dermatological and non-dermatologic, diseases. Delenex’ proprietary PENTRA®Bodies are small, highly potent and stable antibody fragments that are superior in penetrating tissues and in crossing barriers in the human body.

Delenex was founded in September 2009 as a spin-off from ESBATech (now a Novartis company).

For further details please contact:

Jakob Schlapbach, CFO
Delenex Therapeutics AG
Wagistrasse 27
CH-8952 Schlieren
Phone: +41 44 730 5180
E-mail: jakob.schlapbach@delenex.com
Website: www.delenex.com

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