JADO Reports Clinical Proof Of Concept With Raft Modulator In Atopic Dermatitis

Main Category: Dermatology
Also Included In: Clinical Trials / Drug Trials
Article Date: 19 Feb 2008 - 1:00 PDT

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JADO Technologies GmbH, the leading developer of RAFT intervention therapeutics, announced positive results from a Phase IIa clinical trial of its lead RAFT modulator TF002 in patients with severe atopic dermatitis. TF002, a topical formulation of miltefosine, exerts its anti-inflammatory activity via RAFT modulation. RAFTS are sub-compartments in the lipid membrane of cells that play a role in the complex physiological processes, such as immune response.

The randomised, double-blind, active (hydrocortisone) controlled, 17 patient study demonstrated that TF002 met its primary endpoint of significant reduction of inflammation in atopic skin. The anti-inflammatory effect was measured through a highly significant improvement in TIS (Three Item Severity) score after three week treatment. Both TF002 and hydrocortisone achieved an improvement of the TIS score of more than 1.5 which was defined as being clinical efficacious. This result correlates to significant anti-inflammatory effects and clinically relevant efficacy on atopic dermatitis skin. TF002 appeared to have longer-lasting effects in a 4 weeks follow-on examination and did not induce skin atrophy compared to hydrocortisone, which was measured as a secondary outcome. TF002 showed a trend of reducing total number of mast cells.

"This study demonstrates clinical proof of concept for our lead RAFT modulator product TF002 and validates the RAFT based novel mode of action. It encourages us to move ahead with its development. We are now in the process of reformulating the product so that more of the active and less irritable compound is available to the outer layers of the skin, an area where mast cells congregate most. The plan will then be to retest TF002 in placebo and active controlled studies of diseases such as atopic dermatitis where mast cell activation plays a key role," Charl van Zyl, CEO of JADO Technologies stated. "We believe that targeting RAFTS in allergic diseases could potentially lead to effective new treatments without the side effects commonly seen with currently available therapies."

About Atopic Dermatitis

Atopic dermatitis is the most common form of the inflammatory skin disorder, eczema. Approximately 10-20% of the world's population is affected by this chronic and relapsing condition which has a severe impact on quality of life. In many, the condition manifests during childhood, however more than 50% continues to experience symptoms throughout adult life. Although the precise cause is unknown, atopic dermatitis appears to be an abnormal response of the immune system.

About RAFTS

RAFTS are discrete sub-compartments in the lipid membrane of cells that play a central role in the complex physiological processes, such as immune response or in many pathological situations. In an infectious disease event, RAFTS are hijacked by pathogens to gain entry into cells. By blocking this process, JADO is pursuing the development of novel therapeutics.

About JADO Technologies

JADO is a leader in the emerging field of RAFT intervention therapeutics. Representing a paradigm shift in drug development, RAFT therapeutics have the potential to address multiple unmet needs, particularly in allergy, infectious diseases, Alzheimer's disease and cancer.

RAFTS are sub-compartments of cell membranes that play an integral role in key biological pathways. The Company's RAFT Intervention Technology® provides a unique platform, protected by a strong patent position, to drive significant pipeline development opportunities. JADO has leveraged its technology to generate multiple small molecule drug candidates, with its lead program in Phase IIa clinical trials for allergy indications. The Company is supported by a global network of clinical and academic experts, including JADO founders, Prof. Kai Simons, Prof. Marino Zerial, Dr. Teymuras Kurzchalia (Max-Planck Institute of Molecular Cell Biology and Genetics, Dresden) and Prof. Hans-Joachim Knölker (Technical University of Dresden). JADO is headquartered in Dresden, Germany with a subsidiary in Bethlehem, Pennsylvania (USA).

JADO Technologies