Evgen Pharma PLC (AIM:EVG) said preliminary results from a phase Ib study of its new enteric-coated (EC) SFX-01 tablet formulation confirmed the release of the active ingredient beyond the stomach.
As such, a clear dose relationship was demonstrated, with no serious adverse events observed.
Evgen's chief executive, Dr Huw Jones, said: "These top-line results confirm the 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. We have also seen a marked increase in blood levels with increasing dose with no serious adverse events."
The phase I/Ib clinical trial aimed to provide insight into the pharmacokinetic and pharmacodynamic characteristics of the company's lead asset, SFX-01, the active ingredient for which is sulforaphane, which naturally occurs in broccoli and cauliflower.
Pharmacokinetic analysis looks at how the drug is absorbed and circulates in the body, while pharmacodynamics investigates how the drug engages with molecular targets relevant to the disease.
The new tablet formulation, which has additional patent protection, demonstrated that sulforaphane was released beyond the acid environment of the stomach as predicted.
Blood levels of sulforaphane and its active metabolites increased predictably with increasing doses, with total levels in the range previously seen to be effective in pre-clinical experiments and clinical studies for target diseases like breast cancer and glioblastoma.
The new enteric-coated tablet formulation of SFX-01 will replace the previous prototype capsule formulation, offering predictable release and minimising gastrointestinal side effects. The updated formulation is suitable for large-scale trials and commercial supply.
Pharmacodynamic analysis is currently underway, focusing on how the drug modulates disease-relevant molecular targets.
The study is on schedule for full reporting in the second quarter.
As more data emerges from the study, Evgen will provide further updates on SFX-01's effects on specific molecular targets.