TIDMFARN
RNS Number : 3540C
Faron Pharmaceuticals Oy
16 October 2020
Faron Pharmaceuticals Oy
("Faron" or the "Company")
First Results from WHO Solidarity Trial
WHO concludes that subcutaneous IFN beta-1a is ineffective in
hospitalized COVID-19 patients
Company announcement, 16 October 2020 at 1.35 PM (EEST)
TURKU, FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First
North: FARON), a clinical stage biopharmaceutical company, today
announces that the first results from the World Health
Organization's (WHO) Solidarity trial have been made available as a
preprint at medRxiv(1) while under review for publication in a
medical journal. The results show that subcutaneous interferon
(IFN) beta-1a was found to be safe, but ineffective to reduce
overall mortality in hospitalized patients with COVID-19.
The WHO's intent-to-treat analysis compared 1412 patients who
received IFN beta-1a and 2050 control subjects not receiving IFN
beta-1a. The use of corticosteroids was 50% across the study.
Overall in-hospital mortality (the primary endpoint) was 12.9% in
the IFN beta-1a group and 11% in the control group, RR 1.16 (95%
CI, 0.96 - 1.39, NS). The WHO reports that patients mainly received
subcutaneous IFN beta-1a (Rebif, Merck KGaA). At the time of the
data-cut for this analysis, Traumakine, the Company's intravenous
(iv) formulation of IFN beta-1a, became available very late in the
observation period and it is the Company's understanding it had
seldom been used. The WHO has not been able to verify how many
patients received Traumakine at the time of this analysis. About
half of the patients receiving IFN beta-1a also received
concomitant corticosteroids.
Dr. Markku Jalkanen, Faron's CEO, said: "These first results
from the Solidarity Trial are disappointing, given the need for new
therapeutics to support the global response to COVID-19. They do
support our long held view that IFN beta-1a is likely to be
ineffective when given subcutaneously. The science behind
Traumakine and its potential to prevent multi-organ failure,
through the upregulation of the key endothelial enzyme CD73, is
compelling and we continue to believe that an intravenous
formulation of IFN beta-1a is what patients need, to strengthen the
body's own IFN beta signalling - the first line of defence against
viral infection - and provide optimal exposure to the lung
vasculature(2) .
"Compared to subcutaneous IFN beta-1a, the same amount of
intravenous IFN beta-1a achieves over 150x higher peak
concentration in the lung vasculature without higher systemic
exposure(3) , which we believe makes this method of administration
highly effective and safe. We will continue to pursue the science
behind this."
Traumakine continues to be investigated in the ongoing global
REMAP-CAP (Randomized, Embedded, Multifactorial Adaptive Platform
Trial for Community-Acquired Pneumonia) trial, which is evaluating
potential treatments for community-acquired pneumonia, including in
COVID-19 patients, and is currently ongoing across more than 200
sites and 19 countries.
Faron is also supporting a US trial to investigate the potential
of Traumakine to treat COVID-19. HIBISCUS (Human Interferon Beta In
Severe CoronavirUS), an investigator initiated study at Harvard
Medical School's Beth Israel Deaconess Medical Center (BIDMC),
focused on ICU patients with ARDS caused by viral infection (e.g.
COVID-19, influenza). Commencement of this Phase II/III pivotal,
randomized, placebo-controlled study, remains subject to
finalisation of funding arrangements and regulatory approval. The
study will test Traumakine against both placebo and dexamethasone,
which is now a part of the standard of care in the US.
References
1. https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1
2. Interferon beta-1a for COVID-19: critical importance of the
administration route, Jalkanen et al., Critical Care (2020) 24:335
https://doi.org/10.1186/s13054-020-03048-5
3. Buchwalder et al. Pharmacokinetics and Pharmacodynamics of
IFN-b1a in Healthy Volunteers. Journal of Interferon and Cytokine
Research 2020; 20:857-866.
Notes to editors
Further information on the results of the Solidary trial is
available at
https://www.who.int/news/item/15-10-2020-solidarity-therapeutics-trial-produces-conclusive-evidence-on-the-effectiveness-of-repurposed-drugs-for-covid-19-in-record-time
.
The preprint is available at
https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1
For more information please contact:
Faron Pharmaceuticals Oy
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com
Cairn Financial Advisers LLP, Nomad
Sandy Jamieson, Jo Turner, Mark Rogers
Phone: +44 207 213 0880
Panmure Gordon (UK) Limited, Broker
Rupert Dearden
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
Stern Investor Relations
Julie Seidel, Naina Zaman
Phone: +1 212 362 1200
E-mail: faron@sternir.com
About Faron Pharmaceuticals Oy
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 (bexmarilimab), its
investigative 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 is currently being tested in several Phase III studies
around the world against COVID-19. Traumakine is intravenous IFN
beta-1a, which is a strong anti-viral and anti-inflammatory agent.
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",
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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
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