Evgen Pharma PLC Interim Safety and Futility Analysis - STAR trial (6838E)
09 Julio 2021 - 1:00AM
UK Regulatory
TIDMEVG
RNS Number : 6838E
Evgen Pharma PLC
09 July 2021
9 July 2021
Evgen Pharma plc
("Evgen" or the "Company")
Interim Safety and Futility Analysis, STAR COVID-19 Study
Evgen Pharma plc (AIM: EVG), a clinical stage drug development
company, announces the results of the interim safety and futility
assessment readout of the first 100 patients treated in the STAR
COVID-19 ("SFX-01 Treatment for Acute Respiratory infections")
trial.
The double blind, randomised, placebo-controlled Phase II/III
trial was to assess the Company's lead asset, SFX-01, plus standard
care in patients initially hospitalised with community acquired
pneumonia (including patients investigated for suspected COVID19
infection). The trial has been co-sponsored by the University of
Dundee and NHS Tayside and funded by the UK charity LifeArc. An
interim analysis of the efficacy and safety data on the first 100
patients who received SFX-01 or placebo was reviewed by an
independent data management committee, and this was extended to
incorporate the full 133 patients recruited to date. Evgen was
informed this week that the committee had concluded the analyses
did not meet the interim futility hurdle required to continue the
study, and that active treatment would not be likely to show an
overall statistically significant improvement. Recruitment into the
trial will therefore be halted. Importantly there were no safety
issues observed relating to active treatment, further underlying
the excellent safety profile of SFX-01.
The original hypothesis was that upregulation of the
transcription factor Nrf2 would lead to reduction of the severity
of respiratory disease. This will be investigated further as part
of a deeper analysis of the full unblinded clinical and biomarker
data set, including an assessment of the association of variables
such as patient demographics and changes in standard treatment
options over time. These results will be reported in due
course.
Dr Huw Jones, CEO of Evgen, commented : "We are surprised and
disappointed by these findings given the strong preclinical
hypothesis surrounding sulforaphane as an Nrf2 activator with
potential direct antiviral properties. Following this readout, we
will continue to work with the University of Dundee on full data
analysis of active treatment versus placebo on disease-related
endpoints and biomarkers so that we can learn from this important
work. It is reassuring that there were no safety issues related to
active treatment with SFX-01 and the study provides further safety
and drug exposure data in a substantial number of seriously ill
patients.
"The Company mounted a rapid and important response to the
current pandemic advised by colleagues in Dundee. From our point of
view, the programme was always opportunistic and driven by urgent
clinical need. The financial contribution from Evgen was not
significant and we reiterate that our core programmes remain
oncology focused. Complementing our positive phase 2 clinical data
in metastatic breast cancer we have recently reported further
positive data in cells derived from patients who had developed
resistance to the widely used class of CDK4/6 inhibitors. We have
also recently reported compelling data in pre-clinical models in
glioblastoma from two academic centres. The Company is extremely
well funded and we look forward to updating the market further as
our oncology data sets strengthen and will continue to pursue
attractive commercial opportunities for SFX-01."
The information communicated in this announcement is inside
information for the purposes of Article 7 of EU Regulation
596/2014.
Enquiries:
Evgen Pharma plc www.evgen.com via Walbrook
Dr Huw Jones, CEO
Richard Moulson, CFO
finnCap www.finncap.com +44 (0)20 7220 0500
Geoff Nash / Teddy Whiley (Corporate
Finance)
Alice Lane (ECM)
Walbrook PR +44 (0)20 7933 878 or evgen@walbrookpr.com
+44 (0)7876 741 001 / +44 (0)7980
Anna Dunphy / Paul McManus 541 893
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 lead product, SFX-01, is a patented composition
of synthetic sulforaphane and alpha-cyclodextrin.
Clinical data from the Company's open-label Phase II STEM trial
has shown that SFX-01 can halt the growth of progressing tumours in
patients with oestrogen-positive (ER+) metastatic breast cancer,
and in some cases significantly shrink the tumour, whilst causing
very few side effects.
The Company has its headquarters at Alderley Park, Cheshire, and
its registered office is at the Liverpool Science Park, Liverpool.
It joined the AIM market of the London Stock Exchange in October
2015 and trades under the ticker symbol EVG.
For further information, please visit: www.evgen.com
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