Evgen Pharma PLC Clinical trial update (7495N)
25 January 2023 - 6:00PM
UK Regulatory
TIDMEVG
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(R), 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 +44 1625 315090
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
/ 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 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(R) 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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