TIDMEVG
RNS Number : 2746J
Evgen Pharma PLC
15 August 2023
Evgen Pharma plc
("Evgen" or "the Company" or "the Group")
Final Clinical Study Report from Phase 1b PK/PD study of new
SFX-01 tablet formulation approved
New formulation of SFX-01 performs as designed, delivers
meaningful levels of drug and metabolites, is safe and well
tolerated
Results to be shared with Evgen Partner, Stalicla in support of
regulatory
submissions for Phase 2 studies in Autism Spectrum Disorder
Alderley Park, UK - 15 August 2023 : Evgen Pharma plc (AIM:
EVG), a clinical stage drug development company developing
sulforaphane-based medicines , reports the final data from its
Phase 1b healthy volunteer study using the Company's new enteric
coated tablet formation of lead asset SFX-01. The data are
contained in the extensive Clinical Study Report (CSR) which has
been approved by the Company and its providers in compliance with
good clinical practice (GCP).
Following the top-level data announced in March 2023, the full
pre-specified pharmacokinetic (PK) and pharmacodynamic (PD)*
dataset from the placebo-controlled, dose-escalating, randomised
study has now been analysed and reported in the approved CSR. The
study aimed to investigate how sulforaphane released from the new
enteric-coated tablet formulation was absorbed from the intestine
and its effects on the physiology of healthy volunteers.
Highlights
-- As reported in March 2023, based on the time course seen,
sulforaphane was released by the new enteric coated tablet beyond
the acid environment of the stomach
-- No serious adverse events were observed
-- Total blood levels of sulforaphane (SFN) and SFN-metabolites
were confirmed in the micromolar range, where efficacy is seen in
vitro
-- Additional pharmacodynamic exploratory investigation,
utilising mRNA sequencing, showed changes in gene expression after
dosing with SFX-01 even in healthy volunteers
In addition to the biomarkers analysed in the study and
contained within the CSR, changes in gene expression were measured
by mRNA sequencing on participants' blood, for placebo and SFX-01
treated subjects that received 600mg once daily. The initial
analysis identified a large number of significant differentially
expressed genes in the SFX-01 treated group, between blood samples
taken before the first dose was administered (baseline) and blood
samples taken after the first dose timepoint (6 hours after first
dose). Further analysis will be undertaken on this large and
complex dataset to gain insight into the particular genes
identified. Further disease-related mechanistic insight will also
be provided from future clinical studies in patients.
Dr Huw Jones, Evgen CEO said:
"The final CSR confirms, as expected, that the new formulation
of SFX-01 is safe and well tolerated at multiple doses. It delivers
the drug at highly relevant blood levels within the timeframes
expected of an enteric coated formulation.
"We are sharing this report with our partner Stalicla SA as part
of our collaboration and will be working with them on supporting
regulatory submissions for Phase 2 trials in Autism Spectrum
Disorder (ASD).
"With this study, we have conducted the most extensive
evaluation of sulforaphane and its metabolites in man ever produced
in a single study and have done this to a drug regulatory standard,
consistent with our business model."
Dr Glen Clack, Evgen CMO added :
"The pharmacodynamic data generate a number of hypotheses
relevant in both oncology and other conditions that we continue to
explore. These insights will be used in our grant-funded
collaborations with the Erasmus Medical Centre in Rotterdam in
glioblastoma and with our partner, Stalicla, in ASD.
"We are very pleased with the results and are eager to move
forward to applying the new formulation to future clinical studies
using SFX-01."
Following the successful completion of this study, all further
regulatory submissions and clinical trials will be conducted using
the new tablet formulation of SFX-01. The new form brings
additional patent protection and replaces the previous prototype
capsule formulation.
*A pharmacokinetic study looks at how the drug is absorbed and
circulates in the body, while a pharmacodynamic study investigates
how the drug exerts its effects in the body including the
biochemical, molecular and physiological mechanisms relevant to
disease.
-Ends-
Enquiries:
Evgen Pharma PLC
Dr Huw Jones, CEO
Dr Helen Kuhlman, CBO +44 1625 466591
FinnCap (Nominated Advisor and
Broker)
Geoff Nash / Teddy Whiley (Corporate
Finance)
Nigel Birks / Harriet Ward (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 SFX-01
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.
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.
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 highly biologically
active 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 and recently a Phase 1b study of the Company's new enteric
coated tablet formulation. The FDA has granted Orphan Drug status
to SFX-01 in malignant glioma. SFX-01 will be investigated
initially in this indication as an investigator sponsored study in
the Netherlands.
The Company also has a wide number of collaborations with
leading academic centres in the UK, Europe and the US as part of
the continuing strategy to build the scientific data for the
compound. Recently, Evgen completed an out-licensing transaction
with Stalicla SA, a Swiss specialist company in neurodevelopmental
disorders, commencing with autism spectrum disorder. The deal, if
successful, will generate milestone payments of $160.5m and a
double-digit royalty on sales.
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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END
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