Evgen Pharma PLC (AIM:EVG) has unveiled the final data from its Phase 1b study of the new enteric-coated tablet formulation of its lead drug, SFX-01.
The study primarily focused on the absorption of sulforaphane, the active ingredient, from the intestine and its subsequent physiological effects on healthy volunteers.
It confirmed that the sulforaphane was successfully released from the new tablet beyond the stomach's acidic environment. Furthermore, there were no serious adverse events reported.
Blood tests revealed the presence of sulforaphane and its metabolites at levels where efficacy has been observed in laboratory settings.
An interesting aspect of the study was the exploratory investigation using mRNA sequencing, which indicated changes in gene expression after dosing with SFX-01, even among the healthy participants.
This research also pinpointed significant variances in gene expression in those treated with SFX-01. The company plans further analysis to better understand the specific genes identified, with hopes of gleaning more insights from subsequent clinical studies.
Dr Glen Clack, Evgen's chief medical officer, said: "The pharmacodynamic data generate several hypotheses that are pertinent not only in oncology but also in other conditions.
"We are enthusiastic about the results and are keen to incorporate the new formulation in upcoming clinical studies involving SFX-01."
In light of these positive results, Evgen intends to share the findings with its partner, Stalicla SA.
This collaboration aims to bolster regulatory submissions for phase II trials focusing on Autism Spectrum Disorder (ASD).
Evgen has said that all subsequent regulatory submissions and clinical trials will employ the new formulation of SFX-01. This new version not only offers enhanced patent protection but also supersedes the previous capsule formulation.