Evgen Pharma has revealed the final data from its Phase Ib healthy volunteer study using the company’s new enteric coated tablet formation of its lead asset SFX-01.
SFX-01 is a patented composition of synthetic sulforaphane and alpha-cyclodextrin. The company has already completed three trials in patients, including a positive open label trial in metastatic breast cancer using a prototype capsule formulation.
The study aimed to investigate how sulforaphane released from the new enteric-coated tablet formulation was absorbed from the intestine and its effects on the physiology of healthy volunteers.
The clinical study report (CSR) showed that, based on the time course seen, sulforaphane was released by the new enteric coated tablet beyond the acid environment of the stomach. No serious adverse events were observed.
In addition, total blood levels of sulforaphane (SFN) and SFN-metabolites were confirmed in the micromolar range, where efficacy is seen in vitro.
In addition to the biomarkers analysed in the study, changes in gene expression were measured by mRNA sequencing on participants’ blood, for placebo and SFX-01 treated subjects that received 600mg once daily.
The initial analysis identified a large number of significant differentially expressed genes in the SFX-01 treated group, between blood samples taken before the first dose was administered (baseline) and blood samples taken after the first dose timepoint (six hours after first dose).
Dr Huw Jones, Evgen CEO, said: “The final CSR confirms, as expected, that the new formulation of SFX-01 is safe and well tolerated at multiple doses. It delivers the drug at highly relevant blood levels within the timeframes expected of an enteric coated formulation.”
The new tablet formulation of SFX-01 will now replace the prototype capsule for future regulatory submissions and clinical trials.
Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World