EVG.L Regulatory News (EVG)

Evgen Pharma plc

("Evgen" or the "Company")

Regulatory approval received for healthy volunteer study to investigate performanceof new SFX-01 formulation

Alderley Park, UK - 29 September 2022: Evgen Pharma plc (AIM: EVG), a clinical stage drug development company developing sulforaphane-based medicines for the treatment of cancer and other indications, has received regulatory and ethical approvals for a healthy volunteer, pharmacokinetic and pharmacodynamic, study to examine the performance of the Company's new enteric coated tablet formulation of lead asset SFX-01.

As well as safety, the study will investigate how sulforaphane released from SFX-01 engages with key molecular targets that are of interest to Evgen's plans for clinical trials in cancer and other indications.

Evgen developed the enteric-coated tablet formulation to replace previously used hand-filled capsules. The new coating is expected to release sulforaphane to a targeted part of the intestine, improving pharmacokinetic properties and minimising gastro-intestinal side effects. The new formulation, if it performs as expected, will be suitable for large scale trials and commercial supply. SFX-01 is the only stabilised sulforaphane suitable for clinical research and eventual approval as a medicine.

Dr Huw Jones, Evgen CEO, commented:

"These approvals will enable us to launch our healthy volunteer study on schedule in the fourth quarter. 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 Phase I/Ib study will be a placebo-controlled, dose-escalating, randomised trial conducted in the UK. It is planned to start in Q4 2022, with results expected in the first half of 2023.

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.

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.

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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 undergone clinical trials 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 area, 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.

The Company has its headquarters and registered office at Alderley Park, Cheshire. It joined the AIM market of the London Stock Exchange in October 2015 and trades under the ticker symbol EVG.  

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