Sodium thiosulfate is a well-known endogenous compound with proven therapeutic benefits in several medical fields. However, until now, its clinical use has been limited to intravenous administration. This mode of delivery has prevented STS from being developed as a chronic therapy, despite strong preclinical evidence of its potential for cardiovascular and vascular diseases. TS Vascular’s novel, patented, tablet formulation is the first to enable effective oral delivery of STS, overcoming a long-standing barrier in the field.
In the upcoming clinical trial at UMCG, TS will be intravenously administered for several hours, in order determine what blood level of TS is needed to become efficacious in patients with primary Raynaud’s Phenomenon. Results, including a PK model, from this study will guide the dose regimen for TS tablets to be used in the second study in which patients with primary Raynaud’s Phenomenon will be orally dosed with TS for 2 weeks. Further development (phase 3) will lead to registration in primary Raynaud’s Phenomenon with the European Medicines Agency (EMA),
By pioneering this breakthrough in formulation science, TS Vascular aims to unlock the full therapeutic potential of STS, offering new hope for patients suffering from various (cardio) vascular diseases with currently limited treatment options, starting with the primary Raynaud Phenomenon.
“This approval marks an important milestone in our mission to develop an accessible, effective treatment for patients with serious (cardio) vascular conditions such as primary Raynaud’s Phenomenon,” said Pierre Peeters, CEO of TS Vascular. “Our patented oral formulation allows STS to finally be explored as a chronic therapy, something that was not possible before due to its instability and tolerability issues in investigated oral formulations thus far.”
