Treatment of XLHED – Where We Are

December 2007
By Christophe Maier

APO200 is a recombinant protein initially designed at the University of Lausanne, Switzerland. It was then further developed at Apoxis as a drug candidate for the treatment of X–Linked Hypohidrotic Ectodermal Dysplasia (XLHED).

Results obtained in two relevant animal models of the XLHED syndrome showed that administration of this product restored the development of sweat glands, teeth and hair with, thus far, an absence of toxicity.

In June 2007, Apoxis was acquired by a Scandinavian biotech company, TopoTarget A/S. Since this program is not aligned with the Topotarget core activities, the company is seeking to disinvest this asset. Due to the nature of the product and its associated risks, it appears that, in the present situation, a new business entity constitutes the best strategy and a guarantee that the project continues to move ahead toward the clinic.

To actively pursue the development of operations, a team composed of Mr. Christophe Maier (Director of Business Development and APO200 Project Leader at Apoxis) and Dr. Stephane Demotz (Head of R&D at Apoxis) was established. This team is committed, and ideally positioned to create this new business venture.

The well–defined plan of the remaining tasks to be accomplished, together with the contacts and collaborations in place, will ensure a swift development pace of the APO200 drug candidate.

The business strategy is based on the out–sourcing of the entirety of the pre–clinical and clinical activities to relevant experts, whilst the professional experience and expertise of the team will ensure an efficient control of the operations and management of the remaining phases of the project.

To achieve this goal, the team is today aiming at securing $6.8 million (€5 million) to conduct the pre–clinical development of APO200 and to complete a combined clinical phase I/II over a period of three years. The team is already in discussions with several potential investors and wishes to complete the round of financing by the end of the year. In parallel, the team explores other alternatives in the event the round of financing is not completed.

During the forthcoming months, the team will strive in one way or another to make sure that the project moves forward.

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