Agreement for supply of SFX-01 for autism clinical trial

Evgen Pharma (AIM: EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, announces that it has entered into a Memorandum of Understanding with Guy's and St Thomas' NHS Foundation Trust ("Guy's and St Thomas'") to advance the Company's lead compound SFX-01, towards a clinical trial in patients diagnosed with Autism Spectrum Disorder ("ASD").

SFX-01, is the Company's lead product and contains a stabilised synthetic sulforaphane molecule. Sulforaphane, within a botanical extract, has previously been demonstrated in small clinical trials in the United States to have potential in the treatment of ASD.

Under the terms of the agreement, Evgen has agreed to supply SFX-01 to support a potential future trial to be sponsored by Guy's and St Thomas' and led by Dr Michael Absoud, Consultant in paediatric neurodisability at the Evelina London Children's Hospital ("Evelina"), which is part of Guy's and St Thomas'. The Trust have agreed to lead the process to secure grant funding and gain clinical trial approval for a randomised, double blind, Phase II clinical trial. Evgen will retain the option to acquire, on fair commercial terms, the clinical data to enable subsequent development, regulatory approval and commercialisation of SFX-01 in ASD.

There are currently no approved medicines for treating the three core symptoms of autism - communication difficulties, social challenges and repetitive behaviour - which have long represented a huge area of unmet clinical need for affected families.

Based on its novel mode-of-action, SFX-01 has the potential to become a first-in-class treatment for the core symptoms of ASD, disrupting the current £3bn ASD market (which includes the use of anti-depressants and anti-psychotics for the treatment of non-core symptoms), making a significant impact on the enormous economic burden to the UK.

Dr Michael Absoud, a consultant in paediatric neurodisability at Evelina, said: "We are working with patient groups to plan a grant application for a Phase II clinical trial programme for children with ASD, hoping to recruit from a consortium of UK hospitals. Our interest, and that of the parents of some children with ASD, was first triggered when a small clinical study showed that sulforaphane helped improve quality of life in autistic young people. Our end goal is improving the range of treatment options available for autistic young people, in order to improve quality of life and independence."

Dr Stephen Franklin, CEO of Evgen Pharma, commented: "As a result of the successful fundraise in April of this year, we are now in a position to expand the toxicology package for SFX-01, which is a prerequisite to being able to support a trial in ASD patients. SFX-01 works by activating the Nrf2 pathway which in turn activates the expression of genes that promote the body's innate capacity to control the oxidative stress and inflammation that underpin many chronic diseases. Targeting the Nrf2 pathway is now a recognised therapeutic strategy for treating neurodegenerative conditions, such as multiple sclerosis, but also neuropsychiatric disorders, where there is encouraging emergent data in conditions such as autism and schizophrenia.

"Supporting investigator-led studies such as this enables us to remain focused on our in-house programmes, whilst recognising that studies of this nature provide promise to new patient groups and mitigate risk for our investor base. We look forward to being able to provide SFX-01 to this trial and to build on the excellent relationship we have with Dr Absoud and the Trust."

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

 

Enquiries:

Evgen Pharma plc

www.evgen.com

Dr Stephen Franklin, CEO

Via Walbrook PR

Richard Moulson, CFO

 

 

 

finnCap

 

Geoff Nash / Teddy Whiley (Corporate Finance)

+44 (0)20 7220 0500            

Alice Lane / Manasa Patil (ECM)

researchlibrary.finncap.com

 

 

WG Partners LLP

+44 (0)20 3705 9330

Nigel Barnes / Claes Spång

 

 

 

Walbrook PR

+44 (0)20 7933 8780 or evgen@walbrookpr.com

Paul McManus / Anna Dunphy

+44 (0)7980 541 893 / +44 (0)7879 741 001

Notes for editors:

About Evgen Pharma plc (www.evgen.com)

Evgen Pharma is a clinical stage drug development company whose lead programmes are in breast cancer and subarachnoid haemorrhage, a type of stroke. 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 lead product, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin. 

The Group commenced operations in January 2008 and has its headquarters at The Colony, Wilmslow, Cheshire, and its registered office is at the Liverpool Science Park, Liverpool.  It joined the London Stock Exchange Alternative Investment Market in October 2015 and trades under the ticker symbol EVG. 

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