BioWorld International Correspondent

PARIS - NicOx SA and Grupo Ferrer Internacional SA have selected a drug candidate for development under their dermatology collaboration. The candidate, NCX 1047, is a new synthetic nitric oxide-donating corticosteroid that could prove to have an improved risk-benefit ratio relative to the more potent compounds currently used.

NicOx, of Sophia Antipolis, France, pointed out that corticosteroids are the most frequently prescribed treatment for a range of skin disorders such as atopic dermatitis, psoriasis and seborrheic dermatitis, but are associated with adverse side effects, such as thinning of the skin (dermal atrophy), which can be permanent and disfiguring in some cases. It is a particular problem with higher potency compounds, and the collaboration between NicOx and Barcelona, Spain-based Ferrer was aimed at improving the risk-benefit ratio of higher potency compounds through the application of NicOx's proprietary technology, which can stimulate anti-inflammatory activity, as well as improve local safety.

NicOx and Ferrer initiated their joint research program on the strength of encouraging clinical results obtained from a prototype NO-donating corticosteroid, which suggested that NO donation might reduce the risk of dermal atrophy by maintaining blood flow in the skin. The companies evaluated the activity and development potential of a number of synthesized NO-donating compounds, beginning with in vitro tests that involved measuring glucocorticoid receptor binding, the level of NO donation and NO-mediated effects.

Compounds that passed the first round were then evaluated in several different in vivo models of skin inflammation, including some related to specific dermatological disorders. Several of the analyzed compounds were shown to have increased activity compared to an equimolar dose of their parent molecule on a number of inflammatory parameters.

NCX 1047 was chosen for its superior overall profile. Its selection for development comes eight months after NicOx and Grupo Ferrer renewed their research, development and marketing agreement covering the application of NO-donating corticosteroids to the treatment of dermatological conditions last September.

Grupo Ferrer will manage and fund the development of NCX 1047 through to regulatory filing, under the oversight of a joint NicOx/Ferrer development committee. The agreement gives the Spanish company an option to license rights to develop and market any product arising from the collaboration in the U.S. and grants it marketing rights in Western Europe, Latin America, francophone Africa and Egypt. NicOx retains its rights in Asia and its right to co-market products directly in Western Europe.