BioWorld International Correspondent

LONDON - Phoqus plc expects to start a U.S. Phase II study of its lead product Chronocort in treating congenital adrenal hyperplasia (CAH) later this month, following the recent filing of an investigational new drug application.

This first U.S. trial will lay the foundations for moves by newly appointed CEO Richard Mason to reposition Phoqus from a drug delivery services specialist to a drug development company.

"We are moving into drug development because we want to have more control, be masters of our own technology and build greater value," Mason told BioWorld International.

Phoqus's drug delivery platform is based on electrostatic deposition - the technology at the heart of photocopying. The company has developed processing equipment that can be applied to the manufacture of four different kinds of tablets; fast dissolving, controlled release, dose loading and image branded.

The first three give fine-tuned control over pharmacodynamics and can improve clinical effectiveness and reduce side effects, the fourth can be used as an anticounterfeiting measure.

To date, the technology mainly has been applied in collaboration with pharmaceutical companies. Now Mason wants to build the in-house portfolio by using it to reprofile existing drugs. "We plan to use biological insights from academic partners to improve the way drugs work, or find new indications," he said. "The advantage of our technology is the amazing level of control it provides over pharmacokinetics."

Mason said Phoqus's technology still will be available to partners, but under license, rather than through collaborations. "It makes sense to do drug development ourselves because these days pharma wants products, not technology."

West Malling, UK-based Phoqus is in discussions with academic groups over potential collaborations, but Mason said it is still "early days" in terms of transforming the company.

However, Chronocort, provides a role model for the type of projects that Mason would like to initiate. The product, which delivers hydrocortisone in the same diurnal pattern as the naturally-generated hormone, is being developed in partnership with Diurnal Ltd, a spinout from Sheffield University.

Along with CAH, the drug is in development for adrenal insufficiency also, and has European and U.S. orphan drug status. Both conditions require patients to take hormone replacement therapy, but currently that cannot be administered with the same release profile as the natural hormone, production of which rises overnight. As a result, disease symptoms are often poorly controlled, and there may be side effects from steroid therapy.

In July Phoqus raised $10 million in a placing to fund the Phase II and Phase III trials of Chronocort in both indications. In addition to the fundraising, the company has a Cooperative Research and Development agreement with the National Institutes of Health, and the U.S. trials will be carried out jointly with the National Institute of Child Health and Human Development and the Warrren G. Magnuson Clinical Center at NIH.

Following completion of the U.S. Phase II study, the harmonized Phase III trials are designed to enable the company to file in both the U.S. and Europe. Mason said the endpoint is to show superiority against the current standard of care as assessed by a recognized biochemical marker.