Evgen Pharma PLC (AIM: EVG) has revealed the conclusive data from its Phase 1b study, which evaluated the new enteric-coated tablet formulation of its primary drug, SFX-01.
The study was designed to assess the absorption of sulforaphane, the active component of SFX-01, in the intestine and to examine its subsequent physiological effects in healthy volunteers.
The results confirmed that sulforaphane was effectively released from the new tablet in an environment beyond the stomach’s acidity. Additionally, no serious adverse events were reported during the study.
Blood tests demonstrated the presence of sulforaphane and its metabolites at levels previously shown to be effective in lab-based experiments.
An intriguing element of this study was the use of mRNA sequencing as an exploratory tool. This analysis revealed changes in gene expression following the administration of SFX-01, even among healthy participants. The research identified significant variations in gene expression in the subjects treated with SFX-01, and further analysis is planned to more comprehensively understand the specific genes involved. This analysis is hoped to provide deeper insights in future clinical studies.
Dr. Glen Clack, Evgen’s Chief Medical Officer, commented: “The pharmacodynamic data generate several hypotheses that are relevant not only in the field of oncology but also for other conditions. We are excited about these findings and look forward to integrating the new formulation in forthcoming clinical trials involving SFX-01.”
Given these encouraging results, Evgen is preparing to discuss the findings with its collaboration partner, Stalicla SA. This partnership is focused on supporting regulatory submissions for Phase II trials, which will target Autism Spectrum Disorder (ASD).
Evgen has announced that all future regulatory submissions and clinical trials will utilize this new formulation of SFX-01. This updated version provides not only stronger patent protection but also represents an improvement over the previous capsule formulation.
