Jado initiates phase II trails of lead RAFT modulator in urticaria

07-04-2008: JADO Technologies GmbH, a developer of RAFT intervention therapeutics, announced the start of a Phase II study to evaluate the safety and efficacy of oral TF002, a formulation of miltefosine, in patients with antihistamine resistant urticaria. TF002 exerts 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 and inflammatory response.

"The start of this systemic trial continues JADO's product development strategy in allergy. Having identified that miltefosine acts via a RAFT mechanism, we want to ensure that we continue to capture the value of the product in the allergy field with our formulations," noted Charl van Zyl, CEO of JADO. "We have made excellent progress with our studies and believe data from this study will continue to support our multi-faceted development program for TF002."

The randomized, double-blind, placebo-controlled study will enroll a total of 75 patients in 7 German centers. The primary end-point of the study is urticaria symptoms assessed by urticaria activity score (UAS) at the end of treatment.

JADO is investigating topical and oral versions of TF002 in Phase II trials in several allergy indications. Proof of concept with the topical formulation in a Phase II study of atopic dermatitis has been achieved. The company and academic collaborators also recently published in Science proof of concept for its Alzheimer's RAFT inhibitor program.