Clinical trial update

RNS Number : 7495N

Evgen Pharma PLC

25 January 2023

 

Evgen Pharma plc

("Evgen" or "the Company" or "the Group")

Update on study to investigate performance of new SFX-01 tablet formulation - all cohorts dosed

Alderley Park, UK - 25 January 2023 : Evgen Pharma plc (AIM: EVG), a clinical stage drug development company  developing sulforaphane-based medicines , announces that further to its announcement of 16 November 2022, it has completed the dosing of all three cohorts of 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 the Company's lead asset SFX-01, as well as investigating how sulforaphane released from SFX-01 engages with molecular targets of interest.

Each cohort comprises 8 healthy volunteers dosed with either SFX-01 or placebo. The dosing has been completed on schedule and analysis of the data is ongoing. The trial is on track to report full data in the second quarter of the year as indicated previously.

The new enteric-coated tablet formulation will replace the previous prototype capsule formulation. 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:

"Our study has been proceeding exactly to plan, and data will be available in Q2 this year, as expected. We anticipate that it will confirm improved delivery of SFX-01 with our new formulation. In addition, it will demonstrate further how sulforaphane engages with key molecular targets as we expand 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 the prototype capsule formulation. 

Evgen's core technology is Sulforadex®, a method for synthesising and stabilising 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	[phone]
FinnCap (Nominated Advisor and Broker) Geoff Nash / Teddy Whiley (Corporate Finance) Alice Lane/ Nigel Birks (ECM)	[phone]
Instinctif Partners Melanie Toyne-Sewell / Rozi Morris / Adam Loudon	[phone] [e-mail]

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 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 safety and efficacy data sets around the compound. With respect to non-core areas, Evgen signed an out-licensing 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. Evgen also has a licensing deal with STALICLA SA in neurodevelopmental disorders and schizophrenia.

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

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

 

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