The Ministry of Health has just authorized human trials (clinical trials) of the P144 peptide. For the development of this therapeutic product, a agreement was signed between ISDIN, laboratory leader in the Spanish dermatological sector, and Digna Biotech, the company that develops the intellectual property (patents) of CIMA. P144 is one of the 30 patents of research center Médica Aplicada (CIMA) of the University of Navarra.

Endorsed by official bodies in Europe and the U.S., P144 has been formulated as a topical treatment for scleroderma, a disease that causes fibrosis of the skin, blood vessels and internal organs such as the lung.

Following authorization from the Ministry of Health, clinical trials are now underway to assess the tolerability and bioavailability of the molecule in humans. The tests will be carried out at the University Clinic of the University of Navarra and the Puerta de Hierro University Hospital in Madrid, following the approval of approval by their respective Clinical Ethics Committees research .

Tests on healthy volunteers

With few exceptions, new drugs must first demonstrate their safety in healthy volunteers (Phase I). Beforehand, they sign a document with the study's data and their informed consent. In addition, they are required to have no toxic habits and to show no clinically significant alterations in the safety tests: complete blood tests, electrocardiogram, physical examination, etc.

Eighteen volunteers will participate in each of the Pamplona and Madrid hospitals, divided into 3 groups of 6. In the first group, some will receive topical treatment with P144 and others with placebo (no active treatment). After one week of daily application without relevant side effects, the second group group will be treated with a higher dose. Similarly, after checking the condition of the skin, the 3rd will be treated. In all groups, 2 persons will receive placebo and 4 will receive the active treatment. Thus, the study avoids exposing all volunteers to the product until its safety has been tested in a stepwise manner.

The two hospitals will set up multidisciplinary teams of experts to supervise the trials: dermatologists, doctors from other specialties, nurses and pharmacologists, among others.

The treatment consists of a daily application of P144 or placebo on the upper back. For 21 consecutive days, the volunteer comes to the hospital for a check-up, answers a few simple questions and applies the cream again. In order to ensure their health, they must return to the center one month after the end of the treatment. By legal prescription, there is an insurance insurance policy to cover possible risks.

If the Phase I clinical essay is successfully completed, the process will continue with Phase II: group of patients from various hospitals in Spain, Germany, England, Italy, Poland and Hungary.
 

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 research center Applied Medicine (CIMA) of the University of Navarra at preclinical, clinical and commercial level. The CIMA, with 400 researchers and other professionals, conducts research in 4 areas: Gene Therapy and Hepatology, Neurosciences, Oncology and Cardiovascular Sciences. It takes advantage of synergies with the Clínica Universitaria de Navarra and the Schools of Science, Pharmacy and Medicine of the University of Navarra to obtain results that can be applied to patients.