Solfarcos -
First liposomal drug for rheumatoid arthritis passes phase I in Portuguese clinical trial
In mid-September 2021, the first clinical trial on healthy volunteers that evaluated the safety and tolerability of a new medicine for rheumatoid arthritis, completely developed in Portugal, ended successfully.
Promoted by Solfarcos and counting on BlueClinical, as responsible for implementing the clinical trial, and Bluepharma, as producer of the investigational medicine, the success of this first test in humans is the completion of research work spanning more than 10 years, by a team that was born in the Center for Biological Engineering at the University of Minho.
Led by Professor Artur Cavaco Paulo, this research is the direct result of two doctoral theses carried out under the Nanofol and Folsmart projects, funded by the European programs FP7 and H2020 and also by the Foundation for Science and Technology.
BlueClinical, whose role as CRO (contract research organization) consisted of obtaining authorizations from regulatory bodies (INFARMED and CEIC) and conducting the clinical trial in its Phase I facilities, and Bluepharma, which had responsibility as CMO (contract manufacturing organization) to produce the investigational medicine according to Good Manufacturing Practices, ensuring its quality, were fundamental partners of the Folsmart consortium and whose contributions will continue in the future.
The treatment in question is based on the methotrexate molecule, the first-line drug for rheumatoid arthritis, encapsulated in a liposome, a lipid nanoparticle, which contains a signaling molecule on its surface that directs the release of the active substance to sites of inflammation – joints affected by rheumatoid arthritis.
In the words of Eugénia Nogueira, one of the researchers responsible for developing this technology, founding partner and CEO of Solfarcos, “the characteristics of these liposomes allow the circulation time of methotrexate to be increased, requiring a much lower dose to produce a similar effect to that of the marketed medicine and, therefore, the occurrence of less significant adverse effects.”
Although it can only be confirmed with the proof-of-concept trial in patients with rheumatoid arthritis, it is expected that liposomal methotrexate will allow greater spacing between doses, going from an injection once a week at the usual dosage, to once every 2 or 4 weeks.
The team of researchers believes they have a medicine in their possession that could have a major impact on the treatment guideline for rheumatoid arthritis. “Our ambition is for liposomal methotrexate to become the first-line treatment for rheumatoid arthritis, because it will allow us to increase the time of use of methotrexate, which is known to be so effective, but only in a limited period of time due to the adverse effects that occur and become intolerable in chronically ill people”, adds Professor Artur Cavaco-Paulo, also a founding partner of Solfarcos and Scientific Director.
The innovation of the technology developed is protected by two patents, registered by the University of Minho, and which Solfarcos has freedom to exploit.
More information HERE.
