EVG.L Regulatory News (EVG)

Evgen Pharma plc

("Evgen" or the "Company")

Study to investigate performance of new SFX-01 tablet formulation

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.

-Ends-

Enquiries:

Notes to Editors

About Evgen Pharma plc 

Evgen Pharma is a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases. The Company's core technology is Sulforadex®, a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane. 

The Company's lead asset, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin and has completed, with a positive outcome, a Phase 2a clinical trial for oestrogen-positive (ER+) metastatic breast cancer. In September 2021 the FDA granted Orphan Drug status to SFX-01 in malignant glioma.

The Company also has a wide number of collaborations with leading academic centres in the UK, Europe and AsiaPac as part of the continuing strategy to build the data set of safety and efficacy around the compound. With respect to non-core areas, Evgen signed an outlicensing deal with JuvLife, the dietary products and functional foods division of Juvenescence Ltd, for the development of a naturally-sourced sulforaphane nutritional health supplement, stabilised using Evgen's Sulforadex® technology. In addition, Evgen has a licensing deal in neurodevelopmental disorders and schizophrenia with Stalicla SA, a company specialising in the identification of specific phenotypes of autism spectrum disorder via a proprietary screening system.

The Company has its headquarters and registered office at Alderley Park, Cheshire. It is listed on the AIM market of the London Stock Exchange and trades under the ticker symbol EVG.  

For further information, please visit: www.evgen.com