First healthy volunteers dosed on schedule
Alderley Park, UK – 16 November 2022 : Evgen Pharma plc (AIM: EVG), a clinical stage drug development company developing sulforaphane-based medicines announces that, further to the announcement on 12 November 2022, it has dosed the first group of healthy volunteers in its placebo-controlled, dose-escalating, randomised Phase I/Ib clinical trial. The study aims to provide further insight into the pharmacokinetic and pharmacodynamic characteristics of the new enteric coated tablet formulation of SFX-01, as well as investigating how sulforaphane released from SFX-01 engages with key molecular targets of interest.
The new enteric-coated tablet formulation will replace the prototype formulation, which used manually-filled capsules. It releases sulforaphane to a targeted part of the intestine, with the goals of predicable release and minimisation of gastro-intestinal side effects. The new formulation, if it performs as expected, will be suitable for large scale trials and commercial supply.
Dr Huw Jones, Evgen CEO, commented:
“This first dosing, on schedule, marks an important further step in our 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.”
SFX-01 is a patented composition of synthetic sulforaphane and alpha-cyclodextrin. The Company has already completed three trials in patients, including a positive open label trial in metastatic breast cancer using a prototype capsule formulation.
Evgen’s core technology is Sulforadex®, a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane. Sulforaphanes have shown potential benefits in neurodevelopmental disorders, oncology and inflammatory conditions. SFX-01, Evgen’s lead asset, is the only stabilised sulforaphane suitable for clinical research and eventual approval as a medicine.
A pharmacokinetic study looks at how the drug is absorbed and circulates in the body, while a pharmacodynamic study investigates how the drug engages with molecular targets relevant to disease. The current healthy volunteer study examines both in a double-blinded placebo-controlled modular design.
Enquiries:
Evgen Pharma plc
Dr Huw Jones, CEO
Richard Moulson, CFO
+44 1625 466591
