Evgen Pharma PLC Study started of new SFX-01 tablet formulation (5254G)
16 Noviembre 2022 - 1:00AM
UK Regulatory
TIDMEVG
RNS Number : 5254G
Evgen Pharma PLC
16 November 2022
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(R), 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:
Evgen Pharma plc
Dr Huw Jones, CEO
Richard Moulson, CFO +44 1625 466591
FinnCap (Nominated Advisor and
Broker)
Geoff Nash / Teddy Whiley (Corporate
Finance)
Alice Lane/Nigel Birks (ECM) +44 20 7220 0500
Instinctif Partners +44 207 457 2020
Melanie Toyne-Sewell / Rozi Morris Evgen@Instinctif.com
/ Agnes Stephens / Adam Loudon
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(R),
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(R) 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
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