Philikos BV Initiates Phase 1/2 Trial of T-Guard® for Systemic Sclerosis

Philikos BV has launched a Phase 1/2 clinical trial to investigate T-Guard® for treating diffuse cutaneous systemic sclerosis (dcSSc). This trial marks a step towards addressing the limited treatment options for this severe autoimmune disorder. Based in Nijmegen, Netherlands, Philikos focuses on antibody-based therapies for immune disorders.

The trial, coded PHIL_TG-01, aims to include 12 adult patients diagnosed with early-stage dcSSc within the last three years, whose conditions remain resistant to current therapies. The primary endpoint is monitoring for grade 3 or higher adverse events. Secondary endpoints review potential improvements in disease status using the Composite Response Index in Systemic Sclerosis over a year.

Ypke van Oosterhout, CEO of Philikos, emphasized T-Guard's potential as an alternative to stem cell transplantation, expected to offer good tolerability and accessibility. Initial results and recommendations are anticipated by late 2025.