The therapy has the potential to treat neurological and oncological conditions
Evgen – a company developing sulforaphane-based treatments – has revealed that it has dosed the first group of healthy volunteers in its placebo-controlled, dose-escalating phase 1/1b clinical trial of SFX-01. The therapy is a patented composition of synthetic sulforaphane and alpha-cyclodextrin.
Research intends to deliver further insights into the pharmacodynamic and pharmacokinetic characteristics of the new enteric coated tablet formulation of SFX-01. It will also investigate how sulforaphane released from the candidate engages with key molecular targets.
The new formulation – which will replace the prototype formulation manually-filled capsules – releases sulforaphane to a targeted part of the intestine, with the goals of predicable release and minimisation of gastro-intestinal side effects. If it performs as expected, SFX-01 will be suitable for large scale trials and commercial supply.
Dr Huw Jones, Evgen’s chief executive officer, explained: “This first dosing, on schedule, marks an important further step in our development plan for SFX-01. We believe it will confirm the improved delivery of SFX-01 through our new formulation.”
“In addition, we will gain further insights into how the asset engages with key molecular targets of interest as Evgen expands into new indications in oncology and neurodevelopmental disorders,” he added.
Evgen has already completed three SFX-01 trials in patients, including a positive open label trial in metastatic breast cancer using a prototype capsule formulation. The company’s core technology is Sulforadex – a method for stabilising and synthesising the naturally occurring compound sulforaphane in addition to novel proprietary analogues based on sulforaphane.
Sulforaphanes have demonstrated potential benefits in neurodevelopmental disorders, oncology and inflammatory conditions. Meanwhile, SFX-01, is the only stabilised sulforaphane suitable for clinical research and eventual approval as a treatment.