ISDIN, laboratory leader in the Spanish dermatological sector, and Digna Biotech, the company that develops the intellectual property (patents) of the University of Navarra's CIMA , initiated in September the Phase II clinical trial essay of the P144 peptide for the treatment of scleroderma. The Ministry of Health authorized in March the human trials of P144, which also has the endorsement of official bodies in Europe (EMEA) and the USA (FDA) as a potential topical treatment for scleroderma, a disease that causes fibrosis of the skin (scarring), blood vessels and internal organs such as the lung.

Phase II began the process of recruiting scleroderma patients to participate in essay. A total of one hundred participants are expected to take part in the study, which will be carried out in hospitals in five European countries: Hungary, Germany, England, Poland and Spain.

essay In addition, during the last few months, the first clinical study to assess the tolerability and bioavailability of the molecule in humans has been carried out at the Clínica Universitaria de Navarra and the Hospital Universitario Puerta de Hierro in Madrid, Spain, with the participation of 36 healthy volunteers. The tests involved 36 healthy volunteers under the supervision of multidisciplinary teams of experts - dermatologists, rheumatologists, pharmacologists and nurses - who certified the safety of the topical treatment.

The P144 peptide is the first therapeutic molecule from research center Applied Medicine (CIMA) of the University of Navarra to be test in patients. To develop P144, a agreement agreement was signed between ISDIN and Digna Biotech, the company that develops the intellectual property (patents) for CIMA. 

About ISDIN

ISDIN is the leading pharmaceutical laboratory in the Spanish dermatological market, with a market share of 9% (8% in the ethical market and 12% in the dermo-pharmaceutical market), and holds a significant position in several Latin American countries and southern Europe. Since its creation in 1975 as a result of agreement of the international groups Puig and Esteve, ISDIN has focused its activity on skin and mucosal care. Gradually, it has also incorporated products aimed at areas such as gynecology, dentistry and pediatrics.

About Digna Biotech and CIMA

Digna Biotech is a biotechnology company created from the agreement between the University of Navarra and a group of investors from the most important companies in Spain. Digna Biotech has as mission statement the development of the intellectual property generated by the CIMA of the University of Navarra at preclinical, clinical and commercial level. The CIMA, with 400 researchers and other professionals, researches in 4 areas: Gene Therapy and Hepatology, Neurosciences, Oncology and Cardiovascular Sciences.