Evgen Pharma PLC (AIM:EVG) said it has dosed its first healthy volunteer with drug candidate SFX-01.
The aim of the phase I/Ib study is to understand how SFX-01 works in its new formulation - as a pill will with an enteric coating that controls the release of the active ingredient that minimises any potential gastrointestinal side effects.
With that in mind, researchers will be assessing how the new coated pill interacts with the body by assessing its pharmacokinetic and pharmacodynamic characteristics.
They will also evaluate how sulforaphane, SFX-01’s active ingredient, engages with "key molecular targets of interest".
To achieve these ends, it is embarking on a placebo-controlled, randomised, dose-escalating analysis of the putative treatment that has been shown to have promise in neurodevelopmental disorders, oncology and inflammatory diseases.
The form of the trial means that half the volunteers enrolled on it will receive the active ingredient at different doses, while the other half will get a placebo pill containing no sulforaphane.
The scientists will not know which group is which until the trial is 'unblinded'.
Chief executive Huw Jones said the dosing of the first patient in the tablet formulation study marked an important further step in Evgen’s development plan for SFX-01.
“We believe it will confirm the improved delivery of SFX-01 through our new formulation. In addition, we will gain further insights into how the asset engages with key molecular targets of interest as Evgen expands into new indications in oncology and neurodevelopmental disorders,” he added.