Digna in press

March 25, 2010 | media: Press Release

Disitertide (P144), jointly developed by ISDIN and Digna Biotech showed a statistically significant improvement versus placebo in the patients that perceived improvement of the treated skin area affected by systemic sclerosis

• After three months of treatment, 42,2% of the patients enrolled in the double blind placebo controlled proof of concept trial, recognized an improvement in the Disitertide treated area compared to the 17,8% of the patients that perceived improvement in the placebo treated area. The difference was statistically significant (p<0,034). • ISDIN and Digna Biotech have decided to continue the development of Disitertide for the systemic sclerosis treatment.

Madrid, March, 25th, 2010.

Digna Biotech and ISDIN have announced today, the results of their Disitertide proof of concept trial in the topical treatment of skin fibrosis in patients with systemic sclerosis. Results of the trial are sufficiently encouraging to continue the clinical development for this indication.

These clinical trials recruited 56 patients with skin fibrosis in 17 European hospitals including 5 EU countries (Spain, Germany, United Kingdom, Poland, Hungary and Italy).

In this study, Disitertide demonstrated, a statiscally significant difference (p<0,034) in the patients that noticed improvement of the treated skin area. The trial was a 3 months randomized, double blind, intra-individual placebo-controlled Phase II study. Following the treatment, 42,2% of the patients recognized an obvious improvement in the Disitertide treated arm compared to the 17,8% of patients that perceived an improvement in the arm treated with placebo. It is important to emphasize the excellent safety profile observed with Disitertide. There were no reports of severe adverse events related to the Disitertide treatment.

Digna Biotech obtained in Europe and USA the Orphan Drug Designation for this product intended for the treatment of systemic sclerosis.

Digna Biotech CEO, Pablo Ortiz, said: "For the first time, a topical TGF-b1 antagonist (Disitertide), showed clinical benefit in patients with systemic sclerosis. This is a relevant finding since Disitertide could be the first drug of a new therapeutic class". ISDIN CEO, Juan Naya, added: "These results encourage us to continue investing in this project to advance towards the market and to be able to offer a substantial improvement in the quality of life of the patients with systemic sclerosis".

About the systemic sclerosis and Disitertide

Systemic sclerosis is a chronic disease characterized by anomalous fibrosis on skin, blood vessels and internal organs such as lungs. The over-expression of TGF-b1 is one of the key etio-pathological factors in the development of this disease. Currently, the treatments provided to these patients improve only the symptoms (palliative care), no curative care is available or this condition.

Disitertide, is a TGF-b1 antagonist. Blocking TGF-b1 could be an important factor to improve fibrosis in different organs and therefore ameliorating various sclerosis conditions. In this regard, Digna Biotech is investigating other potential indications for the Disitertide including cardiac fibrosis, prosthetic implant-induced fibrosis and macular degeneration of retina.

About ISDIN

ISDIN is the first laboratory in the Spanish dermatological market, with a market share of 9% (8% in the ethical product's market and 12% in the pharmaceutical skin care market), with a significant position in numerous Latin-American countries and in the Southern Europe.

The company was created in 1975, following the agreement of two Spanish international companies Puig and Esteve. ISDIN is focused on scientifically tested dermatological products with superior safety profile. Gradually, ISIDN is incorporating products in other areas such as gynaecology, paediatrics and oral care.

For more information,visit: www.isdin.com

About Digna Biotech

Digna Biotech is a spin-off company from the University of Navarra (Pamplona, Spain) and a group of investors representing some of the more important companies in Spain.

Digna Biotech's is a privately held biopharmaceutical company whose mission is to develop and commercialize the IP generated at CIMA (Center for Applied Medical Research, www.cima.es). CIMA is the largest private biomedical research center in Spain with over 400 employees dedicated to R&D in oncology, neurology, cardiovascular and gene therapy. In addition, the company leverages the synergies with the Clinic University of Navarra (CUN) and the schools of Sciences, Pharmacy and Medicine of the University of Navarra to achieve results that can be made available for the patients.

For more information visit: www.dignabiotech.com

<< Back