Solfarcos -

Methotrexate (MTX) is a drug widely used to treat various diseases, including rheumatoid arthritis, an autoimmune inflammatory disorder that manifests primarily in the joints. However, existing treatments often come with significant side effects that not all patients can tolerate, sooner or later leading to therapy abandonment. 

In response to this challenge, Solfarcos researchers have focused on developing an advanced alternative to MTX for rheumatoid arthritis. The approach involves encapsulating MTX within a liposomal formulation (FBL-MTX) targeting pathogenic cells in inflamed joints through a homing peptide. This innovative approach aims to reduce the required dosage of MTX therapy, thereby minimizing side effects and improving patient outcomes.

Preliminary studies, including efficacy and exploratory toxicology tests conducted on arthritic mice during the Folsmart Project, have provided promising results. Additionally, safety pharmacology studies on rats and dogs have not revealed any unexpected adverse effects.

Building on this work, Solfarcos is investing in the Folsmart2Trials project, making significant progresses in the clinical studies designed to evaluate Safety, Tolerability, and Pharmacokinetics of FBL-MTX. In the first-in-human phase I clinical trial, performed in Portugal in the Summer of 2021, healthy volunteers were successfully challenged with  a single intravenous injection of FBL-MTX. The proof-of concept phase II a clinical trial aimed at testing Efficiency, Safety, Tolerability, and Pharmacokinetics of multiple subcutaneous doses of FBL-MTX in patients with rheumatoid arthritis will begin in the Summer of 2024. The outcomes of this study are highly anticipated, after the exploratory results from local tolerance and pharmacokinetics study in minipig showed a very interesting bioavailability profile which, if translated into the target pharmacodynamics in patients, can make FBL-MTX a game-changer in the treatment of rheumatoid arthritis (and other autoimmune inflammatory diseases).

Folsmart Project co-funded by the Industrial Leadership programme from Horizon 2020.

More information about the project HERE.