Evgen Pharma PLC (AIM:EVG) was granted regulatory permission to assess a new coating on its drug that will allow the release of the active ingredient in a targeted part of the intestine.
SFX-01 is currently delivered in capsule form. However, the group has now developed an enteric-covered tablet.
The study of healthy volunteers taking the stabilised sulforaphane-based treatment will assess how the active ingredient engages with ‘key molecular targets that are of interest to Evgen’.
Researchers will also monitor for any potential side effects and how SFX-01 interacts with the body through the analysis of its pharmacokinetic and pharmacodynamic properties.
The drug is being developed to treat cancer, though Evgen is looking at other possible indications.
"These approvals will enable us to launch our healthy volunteer study on schedule in the fourth quarter,” said Evgen chief executive, Dr Huw Jones.
“This important study will provide deeper insights into our new formulation of SFX-01, its metabolism and the way it interacts with selected molecular targets, which will be key to informing future development work and trials.”
The drug developer's core technology is Sulforadex, a method for synthesising naturally occurring compound sulforaphane, which has shown to be beneficial in reducing inflammation and blocking DNA mutation of cancer.