Portuguese company Solfarcos nears an innovative treatment - Clinical trial for innovative methotrexate nanotechnology treatment of Rheumatoid Arthritis.

Solfarcos’ folate-targeted liposomal methotrexate shows promising clinical Phase 2a progress that may reshape rheumatoid arthritis management and support future expansion into additional chronic inflammatory and oncological conditions

Key Phase 2a clinical study highlights
• Designed to integrate an innovative, cost-efficient technology that enhance treatment accessibility and patient well-being;
• Strong indications of reduced acute adverse effects on administration day, improving patient comfort;
• Improved tolerability profile, supporting better adherence and reducing indirect treatment costs;
• Potential for lower dosing frequency (monthly or semi-monthly instead of weekly);
• 7 clinical centers participating in the study in Portugal;
• FBL-MTX is estimated to have the potential of capturing ~1.3% of the RA drug market in the first commercial year (10% of new oral MTX patients + 10% of new SC MTX patients).

The aforementioned results will pave the way to extend the effective use of methotrexate, helping patients remain on a well-established therapy longer and postponing or avoiding transition to significantly more expensive biological treatments. Also, since the proprietary technology developed by Solfarcos can potentially be used for several conditions, the company also expects to broaden the scope of its partnerships moving forward.

Solfarcos, a Portuguese biotechnology company inspired by nature and driven by the transformative potential of peptides, announces significant progress in the clinical development of FBL-MTX, its innovative folate-targeted liposomal methotrexate formulation for rheumatoid arthritis (RA). The therapy addresses a well-recognized challenge in chronic disease management: maintaining the efficacy and accessibility of methotrexate while improving tolerability, reducing treatment burden, and supporting long-term adherence and efficacy. As it gets ready to enter the next phase, the company expects to obtain market approval in 2033 and be the golden standard for rheumatoid arthritis treatment by 2038.
According to Artur Cavaco Paulo, Solfarcos’ CEO and CSO, "for the past seventeen years, FBL-MTX has embodied our vision of combining scientific excellence, technological innovation, and a clear commitment to improving the lives of people suffering from this chronic disease. We firmly believe that we are closer than ever to delivering a methotrexate-based therapy that is effective, accessible, and better aligned with patients’ daily realities."

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