Solfarcos -

The research is being promoted by the biotechnology company Solfarcos, and its partners are Bluepharma and BlueClinical, leading companies in the health sector.

The future 100% Portuguese drug for treating rheumatoid arthritis will begin to be tested on patients after an initial clinical trial was successfully carried out on healthy volunteers. The new study, which aims to assess future drug’s efficacy, safety and tolerability, will involve 40 patients and clinical teams from eight Portuguese hospitals in the north and centre of the country. The kick-off meeting for the new study took place on July 10th.  

The research, led by the biotech company Solfarcos in partnership with Bluepharma and BlueClinical, aims to reduce the doses administered, the frequency of taking the drug, and adverse patient effects. More than 20 million people worldwide suffer from this chronic inflammatory disease.  

The new drug has the methotrexate molecule as its active ingredient, which is already used and is the first-line medication in treating this disease. However, unlike conventional therapy, this substance will now be encapsulated in a liposome, a lipid (fat) nanoparticle which, through a signalling molecule on its surface, will direct the release of the active substance to the sites of inflammation, the joints affected by rheumatoid arthritis. 

According to the researchers, these liposomes will increase the circulation time of methotrexate in the body, requiring a much lower dose to produce an effect similar to that of the drug currently on the market. With the "controlled release of the active substance and the absence of concentration peaks," the adverse patient effects on patients will be reduced.  

Another advantage will be reducing the drug's frequency and increasing the dose spacing. Instead of one subcutaneous injection a week, as with the current dosage, it is estimated that one injection will be administered every 2 to 4 weeks. According to the scientists, this new treatment is also intended to be more practical and straightforward for patients, increasing their adherence to therapy.

The first meeting to introduce the clinical teams to thise new Phase IIa proof-of-concept clinical trial, called "Phase IIa", took place recently at the Solfarcos facilities in Braga (Portugal) and brought together clinical teams from eight Portuguese hospitals, namely ULSAM - Unidade Local de Saúde do Alto Minho, Centro Clínico Académico de Braga (2CA-Braga), ULSAAve - Unidade Local de Saúde do Alto Ave, ULSSJ - Unidade Local de Saúde de São João, ULSGE - Unidade Local de Saúde de Gaia e Espinho, ULSRA - Unidade Local de Saúde da Região de Aveiro, ULSG - Unidade Local de Saúde da Guarda, ULSRL - Unidade Local de Saúde da Região de Leiria. Also present at the event were representatives from the Blueclinical and Bluepharma teams, who have been partners in this project since 2016 and 2017, respectively. 

The trial will last around 12 months and involve 40 patients with rheumatoid arthritis and teams of rheumatologists, internal medicine doctors, nurses, and pharmacists. Throughout the study, the patients will be continuously monitored, and their state of health status will be assessed.  

There is no forecast for the new drug's market entry yet, but the researchers are optimistic about the success of this new study.  

About the research 

The research on which the new drug is based was started at the University of Minho (Portugal) and led to the creation of the company Solfarcos - Soluções Farmacêuticas e Cosméticas, which is promoting the study for its commercial exploitation. The pharmaceutical company Bluepharma is responsible for producing the liposomes, with the participation of Stemmatters - Biotecnologia e Medicina Regenerativa. BlueClinical has been the partner responsible for the regulatory area and for implementing the clinical studies.

This innovation results from research begun fifteen years ago by a team from the CEB - Centre of Biological Engineering of the University of Minho, led by Professor Artur Cavaco Paulo. It is the direct result of two doctoral theses carried out under the Nanofol and the Folsmart projects, funded by the European FP7 and H2020 programs and the Portuguese Foundation for Science and Technology (FCT).  

Two patents registered by the University of Minho protect the innovative technology developed and are exploited by Solfarcos.

The new study on patients diagnosed with rheumatoid arthritis were reported in the national press and on the radio.

See the information in the links below.