The TRIAD project, which was officially completed in December 2014, brought together clinical experts from the EU and Brazil. Its landmark achievement has been preclinical development of the novel drug FR104. This allows for more targeted autoimmune therapies that suppress only the parts of the immune system responsible for an autoimmune attack, while sparing and enhancing regulatory T cells.

These regulatory T cells play a key role in our immune systems by suppressing the immune responses of other cells, and act as a sort of built-in self-check to prevent excessive reactions. Current – less targeted – therapies inhibit certain signals that are crucial to the functioning of regulatory T cells.

Supporting innovative drug development

The next stage is to develop FR104 through clinical trials, leading to eventual commercialisation. Given that autoimmune diseases – such as multiple sclerosis, rheumatoid arthritis, psoriasis, uveitis and atherosclerosis – affect some 8 % of the population, the long-term impact of this project on improving patient wellbeing and reducing healthcare costs could be huge.

“We are a spin-off company that develops biological drugs at the preclinical-to-early clinical level, and are financed mainly by our founders and through crowdfunding,” explains project coordinator Bernard Vanhove, CEO of Effimune. “In order to start manufacturing FR 104 at the industrial level, we needed access to more funding as well as stronger scientific collaboration in order to convince Big Pharma partners to invest.”

Participation in the TRIAD project enabled Effimune to sign a licensing agreement with Janssen Biotech in September 2013, and the drug candidate is now in clinical development. Progress is ongoing; authorisation from the Belgian regulators for a Phase I clinical trial of FR104 was officially received in April 2015.

This double-blind randomised clinical trial will involve 70 healthy volunteers (both men and women) over a period of nine months and will prepare the future development of FR104 in rheumatoid arthritis and kidney and stem cell transplantation. The key objective of the trial is to establish the safety and tolerability of the drug.

A long-term global impact

The TRIAD project demonstrates that providing innovative SMEs with financial support is beneficial not only for small businesses but for society as a whole. In the short term, Effimune’s licensing agreement with Janssen Biotech will result in regular payments from development milestones and royalties on sales made over the coming years.

Looking at the broader picture, investment in drug development enables innovative discoveries and ideas to blossom, leading eventually to cures or longer lasting remissions that will have a direct impact on national healthcare budgets.

The project also promises to have a global impact. “Throughout this project, we interacted with the best European labs in the field and created a network that is still interacting following completion of TRIAD in 2014,” says Vanhove. “We also worked with a Brazilian partner at the Instituto Israelita Albert Einstein, São Paulo, which is willing to conduct a clinical trial of the drug candidate in South America (the trial will focus on the treatment of uveitis, an autoimmune affection of the eye that accounts for 25 % of all cases of blindness worldwide). This project created the unique opportunity to conduct such a trial.”

Website of EUmbrella (EU-Brazil cooperative projects)