TIDMFARN
RNS Number : 8270M
Faron Pharmaceuticals Oy
26 January 2021
Faron Pharmaceuticals Oy
("Faron" or the "Company")
Update on TRAUMAKINE development
- U.S. Food and Drug Administration (FDA) approval of new
HIBISCUS study protocol in patients with COVID-19 infection
- Company seeking patent protection for the sequential use of IV
interferon beta-1a and corticosteroids
- Pipeline expansion into additional organ protection indications
- CMC scale-up in progress
Company announcement, 26 January 2021 at 9.00 AM (EET)
Inside information
TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First
North: FARON), the clinical stage biopharmaceutical company,
announces that the U.S. Food and Drug Administration (FDA) has
approved the Phase II/III HIBISCUS trial assessing Traumakine,
Faron's intravenous (IV) IFN beta-1a, for the treatment of
hospitalised patients with COVID-19. In the study Traumakine will
be used prior to the current practice of corticosteroids, to
prevent systemic inflammatory response syndrome (SIRS) and acute
respiratory distress syndrome (ARDS), to improve clinical condition
and reduce patient death. The study sponsorship has now been
changed to Faron, with Professor Daniel Talmor from Harvard
University's Beth Israel Deaconess Medical Center, as the Principal
Investigator.
The mode of action of Traumakine is, in addition to a profound
antiviral effect, to upregulate the cell surface protein, Cluster
of Differentiation 73 (CD73). SIRS may be caused by both infectious
assaults such as COVID-19, influenza and other micro-organisms, as
well as noninfectious insults, such as trauma, ischemia-reperfusion
injury or burns. SIRS is characterised by early excessive
inflammatory cytokine production, initiated by extracellular ATP, a
potent mediator of inflammation and thrombosis, which can also lead
to vascular dysfunction, capillary leak and thrombosis, ultimately
leading to life-threatening multiple organ dysfunction syndrome
(MODS).
HIBISCUS study
The Human intravenous Interferon Beta-Ia Safety and preliminary
efficacy in hospitalized subjects with CoronavirUS (HIBISCUS) phase
II/III study will be conducted in approximately 5-10 study sites
across the US in hospitalised patients with COVID-19, who do not
yet require mechanical ventilation, but maximally low flow oxygen
support. Use of corticosteroids concomitantly with Traumakine is
not possible in the study setting but enabled in a sequenced manner
after Traumakine. Faron has also applied for new patent protection
relating to the induction of CD73 for organ protection, followed by
the use of steroids for the treatment of systemic inflammation.
Hence, the best effects of both drugs are optimised in a sequence
for patient benefit.
The study will recruit 140 hospitalised COVID-19 patients with
1:1 randomisation assessing Traumakine against placebo with a
primary endpoint of clinical status (WHO 9-point ordinal scale) at
day 14. Secondary endpoints are clinical status at day 28, and
in-hospital mortality at day 28 and day 90. The study protocol will
have an interim analysis once 70 trial subjects have been assessed
for the primary efficacy endpoint (clinical status at day 14). A
further assessment of the conditional power will also be conducted
in the interim analysis based on the observed result and the sample
size will be adjusted accordingly, allowing completion of the study
with confidence for regulatory compliance.
Dr. Markku Jalkanen, Faron's CEO, said: "We are pleased to have
received approval from the FDA to commence our phase II/III
HIBISCUS trial of intravenous IFN beta-1a in COVID-19 patients. IFN
beta-1a has previously demonstrated a compelling scientific
rationale as the body's first line of defense against viral
infections and might be advantageous over current standard of care
when given intravenously to patients suffering from COVID-19
induced ARDS. This trial will allow us to gain important insights
into Traumakine's potential in this particular setting and we
believe that this sequential administration of intravenous
interferon beta, before corticosteroids, could become a standard of
care in the future and as such have filed a patent application to
protect the commercial opportunity.
"There have been no innovative new drugs in the field of
emergency care for decades and it remains a highly underserved area
of medicine in respect to therapeutics. We strongly believe that
vital organs can be better protected by the induction of CD73 and
so we are pleased to be continuing the development of Traumakine
through a number of important trials and collaborations. As such,
we are continuing to scale up our manufacturing process with AGC
Biologics as we work to create a new, state of the art
manufacturing facility for Traumakine."
Collaboration with US Department of Defense to explore
additional organ protection indications
As previously communicated, the U.S. Department of Defense
("DoD") has selected the HIBISCUS Study to receive $6.1 million of
funding from the Coronavirus Aid, Relief, and Economic Security
(CARES) Act. As part of a working relationship established with
Faron, the 59(th) Medical Wing of the US Air Force and the DoD will
continue primate studies to evaluate Traumakine's role in
preventing multiple organ dysfunction syndrome (MODS) after
ischemia-reperfusion injury caused by a major trauma.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014 ("MAR").
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
Phone: +358 (0)40 555 4727
Jukka Järvelä
Phone: +358 (0)50 55 38 990
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
Phone: +1 212 362 1200
Email: julie.seidel@sternir.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 (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",
"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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