TIDMFARN
RNS Number : 3977N
Faron Pharmaceuticals Oy
20 May 2020
Faron Pharmaceuticals Oy
("Faron" or the "Company")
Harmful association of glucocorticoids in interferon beta-1a
treated patients published in Intensive Care Medicine
- Detailed analyses following INTEREST trial conclude
glucocorticoids block the upregulation of CD73 in the lung
capillaries and inhibit interferon signalling
Company announcement, 20 May 2020 at 9.00 AM (EET)
TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First
North: FARON), the clinical stage biopharmaceutical company,
announces today that the results of its detailed analyses into the
effects of glucocorticoids on intravenous (IV) interferon (IFN)
beta-1a activity, which arose following the INTEREST trial in 2018,
have been published in Intensive Care Medicine, a world leading
journal in the field of critical care.
The results showed that the desired mechanism of action of IV
IFN beta-1a in the lung vasculature - the upregulation of CD73 - is
blocked by the administration of glucocorticoids. In addition, the
administration of glucocorticoids with IV IFN beta-1a increases
mortality in patients with acute respiratory distress syndrome
(ARDS) compared to patients administered with IV IFN beta-1a alone.
As previously announced, analysis from the INTEREST trial showed
Day-28 mortality for patients receiving concomitant glucocorticoids
with IV IFN beta-1a was 39.7% compared to 10.6% for patients
receiving IV IFN beta-1a alone (p < 0.001).
Dr. Markku Jalkanen, Faron's CEO, said: "This is a crucial
publication for the critical care community, detailing the
important scientific detective work that has been undertaken since
the unexpected readout from the INTEREST trial. It is especially
important in these times when ICUs are filled with COVID-19
patients, many of whom may be receiving treatment with
glucocorticoids. Prior clinical data have shown that
glucocorticoids are harmful in viral-induced ARDS and the World
Health Organization has already recommended not to use
glucocorticoids in severely ill COVID-19 patients. These published
and peer-reviewed data give us the mechanistic reason why and the
results are without dispute. The potential lung protective effects
of interferon beta through upregulation of CD73, should it be
endogenous or exogenous, are lost with the administration of
glucocorticoids."
In recent weeks Faron has announced that its investigational IV
IFN beta-1a (Traumakine) is being trialled in two global studies
investigating potential COVID-19 treatments - the World Health
Organization (WHO) Solidarity study, involving over 90 countries,
and the global REMAP-CAP trial (Randomized, Embedded,
Multifactorial Adaptive Platform Trial for Community-Acquired
Pneumonia) underway across close to 200 sites in 14 countries. The
Company continues to develop Traumakine as a treatment for ARDS
patients. As previously announced, in March the U.S. Food and Drug
Administration (FDA) accepted the Company's proposed protocol
design for the next Traumakine study, which will exclude the use of
concomitant glucocorticoids.
"Glucocorticoids inhibit type I IFN beta signaling and the
upregulation of CD73 in human lung" in Intensive Care Medicine can
be found here .
For more information please contact:
Faron Pharmaceuticals Oy
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com
Panmure Gordon (UK) Limited, Nomad and Broker
Emma Earl, Freddy Crossley (Corporate Finance)
James Stearns (Corporate Broking)
Phone: +44 207 886 2500
Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen, Jussi Majamaa
Phone: +358 (0)40 555 4727
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com
About Faron Pharmaceuticals Ltd
Faron (AIM: FARN, First North: FARON) is a clinical stage
biopharmaceutical company developing novel treatments for medical
conditions with significant unmet needs. The Company currently has
a pipeline based on the receptors involved in regulation of immune
response in oncology and organ damage. Clevegen, its precision
immunotherapy, is a novel anti-Clever-1 antibody with the ability
to switch immune suppression to immune activation in various
conditions, with potential across oncology, infectious disease and
vaccine development. Currently in phase I/II clinical development
as a novel macrophage checkpoint immunotherapy for patients with
untreatable solid tumours, Clevegen has potential as a single-agent
therapy or in combination with other standard treatments including
immune checkpoint molecules. Traumakine, the Company's pipeline
candidate to prevent vascular leakage and organ failures, has
completed a phase III clinical trial in Acute Respiratory Distress
Syndrome (ARDS). Plans for its future development are being
finalised to avoid interfering steroid use together with
Traumakine. Faron is based in Turku, Finland. Further information
is available at www.faron.com
Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed
to be, forward looking statements. Forward looking statements are
identified by their use of terms and phrases such as "believe",
"could", "should", "expect", "hope", "seek", "envisage",
"estimate", "intend", "may", "plan", "potentially", "will" or the
negative of those, variations or comparable expressions, including
references to assumptions. These forward-looking statements are not
based on historical facts but rather on the Directors' current
expectations and assumptions regarding the Company's future growth,
results of operations, performance, future capital and other
expenditures (including the amount, nature and sources of funding
thereof), competitive advantages, business prospects and
opportunities. Such forward looking statements reflect the
Directors' current beliefs and assumptions and are based on
information currently available to the Directors.
A number of factors could cause actual results to differ
materially from the results and expectations discussed in the
forward-looking statements, many of which are beyond the control of
the Company. In particular, the early data from initial patients in
the MATINS trial may not be replicated in larger patient numbers
and the outcome of clinical trials may not be favourable or
clinical trials over and above those currently planned may be
required before the Company is able to apply for marketing approval
for a product. In addition, other factors which could cause actual
results to differ materially include the ability of the Company to
successfully licence its programmes within the anticipated
timeframe or at all, risks associated with vulnerability to general
economic and business conditions, competition, environmental and
other regulatory changes, actions by governmental authorities, the
availability of capital markets or other sources of funding,
reliance on key personnel, uninsured and underinsured losses and
other factors. Although any forward-looking statements contained in
this announcement are based upon what the Directors believe to be
reasonable assumptions, the Company cannot assure investors that
actual results will be consistent with such forward looking
statements. Accordingly, readers are cautioned not to place undue
reliance on forward looking statements. Subject to any continuing
obligations under applicable law or any relevant AIM Rule
requirements, in providing this information the Company does not
undertake any obligation to publicly update or revise any of the
forward-looking statements or to advise of any change in events,
conditions or circumstances on which any such statement is
based.
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END
MSCFLFEEEVIALII
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