Study involves SFX-01 candidate and emerging preliminary pharmacokinetic data from study
Evgen Pharma – a company developing sulforaphane-based treatments – has announced top line pharmacokinetic data relating its dose-escalating, placebo-controlled, randomised phase 1/1b clinical trial.
The research aimed to provide additional insights into the pharmacodynamic and pharmacokinetic characteristics of Evgen’s new enteric coated (EC) tablet formulation based on the company’s lead candidate, SFX-01.
SFX-01 releases sulforaphane to a targeted part of the intestine, with the goals of predicable release and minimisation of gastro-intestinal side effects. Also, the new formulation is suitable for wider scale trials and, ultimately, commercial supply.
The study will also explore how sulforaphane released from the tablet engages with molecular targets of interest.
During the clinical trial sulforaphane released from the tablet went beyond the acid environment of the stomach, while levels of sulforaphane increased predictably with increasing dose.
Meanwhile, total levels of sulforaphane and active metabolites in blood were in the range previously seen to be effective in pre-clinical experiments. Furthermore, no serious adverse events observed during the course of the study.
Dr Huw Jones, chief executive officer at Evgen, was optimistic about the results: “These top line results confirm release of the active ingredient from SFX-01 to the bloodstream in a time course that shows our new enteric coated tablet works as predicted.”
He added: “We have also seen a marked increase in blood levels with increasing dose, with no serious adverse events. The full analysis of the data continues, focusing on SXF-01’s effects on particular molecular targets and we will provide further updates as key data from this insightful study emerge.”
SFX-01 will replace the former prototype capsule formulation, while the new form of active ingredient in the tablet has additional patent protection.