SOPHIA ANTIPOLIS, France, May 16 /PRNewswire/ -- NicOx S.A. (Eurolist: NICOX) today announced that NicOx and Grupo Ferrer Internacional, S.A. have selected NCX 1047 as the development candidate in their dermatology collaboration. The selection of NCX 1047 marks the successful completion of the partners' research program, announced in September 2005, to identify a new synthetic nitric oxide (NO)-donating corticosteroid with the potential for an improved risk-benefit ratio.
Ennio Ongini, Vice President of Research at NicOx, commented: "The identification of a development candidate only eight months after the expansion of our alliance with Ferrer reflects the determined hard work of the joint research team and highlights the ability of our technology to generate drug candidates within a short timeframe. We believe there is a clear market need for a higher potency corticosteroid with improved local safety and tolerability, or which could be used more sparingly due to increased activity. Both partners are eager to complete pre-clinical development of NCX 1047 and initiate clinical development as soon as possible."
Ferrer and NicOx were jointly responsible for this research project, in which a number of NO-donating compounds were synthesized and assessed for their activity and suitability for development. The first round of testing was conducted in vitro and involved measuring glucocorticoid receptor binding, the level of NO donation and NO-mediated effects. Compounds successfully passing this first round were assessed 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 due to its superior overall profile. Ferrer will manage and fund all development of NCX 1047 through to registration, under the oversight of a joint NicOx and Ferrer development committee.
Antonio Guglietta, Vice President of Research and Development at Ferrer, added: "We are very pleased with the rapid progress that has been made in this important collaboration with NicOx, which seeks to improve the risk-benefit profile of commonly used dermatology products. The Ferrer team is well aware of the commercial potential of this program, due to our existing sales and marketing expertise in dermatology, and we therefore look forward to the initiation of clinical studies for NCX 1047."
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 local side effects, such as thinning of the skin (dermal atrophy), which can be permanent and disfiguring in some cases. This is a particular problem with the higher potency compounds which are most commonly used in current clinical practice. This collaboration aims to improve the risk-benefit ratio of these higher potency compounds, using NicOx' proprietary technology to improve local safety and possibly improve anti- inflammatory activity.
NicOx and Ferrer initiated the research program focused on higher potency agents following the encouraging clinical results from a prototype NO-donating corticosteroid, which suggested that NO donation may reduce the risk of dermal atrophy by maintaining blood flow in the skin. Additionally, the proposed role of NO in a number of biological processes in the skin suggests that NicOx' technology could increase the efficacy and reduce the side effects of these agents.
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven biopharmaceutical company dedicated to the development of nitric oxide- donating drugs to meet unmet medical needs. NicOx is targeting the therapeutic areas of pain and inflammation and cardio-metabolic disease. Resources are focused on two lead compounds, HCT 3012, in phase 3 development for the treatment of osteoarthritis, and NCX 4016, in phase 2 for Peripheral Arterial Obstructive Disease (PAOD). NicOx has strategic partnerships with some of the world's leading pharmaceutical companies, including Pfizer Inc. and Merck and Co., Inc. NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a public company listed on the Eurolist of Euronext Paris (segment: Next Economy).
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