The companies DIGNA Biotech and ISDIN are going to start a new clinical essay of Disitertide (P144) to continue the development of the product in patients with scleroderma or systemic sclerosis. Recently this cream has shown a subjective and statistically significant improvement of the treated area, in a Phase II clinical essay conducted in 17 European hospitals in Spain, Germany, United Kingdom, Poland, Hungary and Italy. Specifically, after three months of treatment, 42% of patients reported an improvement in the arm treated with Disitertide. Moreover, no treatment-related serious adverse effects have been reported. As will be recalled, DIGNA Biotech had already obtained 'orphan drug' designation for the product in Europe and the US for the treatment of systemic sclerosis. It is a molecule (P144) patented by the research center Médica Aplicada (CIMA) of the University of Navarra.

According to Dr. Pablo Ortiz, director general manager of DIGNA Biotech, "for the first time a topically administered TGF-β1 inhibitor, such as Disitertide, has shown a sign of subjective improvement in patients with systemic sclerosis. This fact is of special relevance because we may have in our hands the first representative of a new therapeutic class ". For his part, Juan Naya, director general manager of ISDIN added that "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 patients with systemic sclerosis".

Chronic disease

Systemic sclerosis is a chronic disease characterized by fibrosis of the skin, blood vessels and internal organs such as the lung. At present, there is no treatment that cures the disease, only symptomatic treatments of dubious efficacy.

Disitertide is an inhibitor of TGF- β1, one of the factors core topic in the development of this pathology. In parallel, DIGNA Biotech is investigating other potential indications for this product, such as cardiac fibrosis, fibrosis following implantation of a foreign body such as silicone, macular degeneration of the retina, and melanoma. For all of these, the company already has a positive concept test in animal models.