Faron Pharmaceuticals Oy FDA approval of Faron's Traumakine® IND (7272C)
January 24 2018 - 1:00AM
UK Regulatory
TIDMFARN
RNS Number : 7272C
Faron Pharmaceuticals Oy
24 January 2018
Faron Pharmaceuticals Ltd
("Faron" or the "Company")
FDA has approved Faron's Traumakine(R) IND
TURKU - FINLAND, 24 January 2018 - Faron Pharmaceuticals Ltd
("Faron") (AIM: FARN), the clinical stage biopharmaceutical
company, announces that the US Food and Drug Administration (FDA)
has approved the Investigational New Drug (IND) Application for
Traumakine, the Company's wholly-owned product for the treatment of
Acute Respiratory Distress Syndrome (ARDS), which is part of the
regulatory process towards BLA submission.
The FDA has already proposed that Faron can proceed directly to
Biologics License Application (BLA) pending positive results from
the two on-going Phase III trials (INTEREST in Europe and MR11A8-2
in Japan) and the IND forms part of this process towards BLA
submission. Faron also continues to consider providing access to
Traumakine in the US to ARDS patients under an expanded access
program, which requires an IND. Top-line data from the INTERST
study is due in the first half of 2018.
Faron is also planning to conduct a small open label study in
the US for pharmacological purposes and the IND will allow opening
of clinical activities in the US. This first US study will target
Traumakine (drug product FP-1201-lyo) in moderate and severe ARDS
patients, especially with end organ (kidney and liver)
failures.
ARDS is a severe orphan disease with a reported mortality rate
of approximately 30-45%[1](,[2],[3],) for which there is currently
no approved pharmacological treatment. It is characterised by
widespread capillary leakage and inflammation in the lungs, most
often as a result of pneumonia (e.g. following a pandemic
influenza), sepsis, or significant trauma. Faron estimates there
are around 300,000 plus annual cases in Europe and US alone. Faron
completed the recruitment of 300 patients with moderate and severe
ARDS for the pan-European pivotal trial INTEREST in December
2017.
Dr Markku Jalkanen, CEO of Faron, said: "We are very pleased to
receive this IND approval from the FDA which will allow us to
further advance our Traumakine plans in the US. It also allows
rolling dossier build up for FDA, which can speed up the final BLA
acceptance. With data expected in H1 2018 and, following previous
guidance from the FDA, we remain hopeful that we can expedite
Traumakine's route to market addressing this significant unmet
medical need in terms of reducing mortality and providing savings
for healthcare systems."
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 Ltd
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com
Consilium Strategic Communications
Mary-Jane Elliott, Chris Welsh, Philippa Gardner, Lindsey
Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com
Westwicke Partners, IR (US)
Chris Brinzey
Phone: 01 339 970 2843
E-Mail: chris.brinzey@westwicke.com
Panmure Gordon (UK) Limited, Nomad and Broker
Freddy Crossley (Corporate Finance)
Tom Salvesen (Corporate Broking)
Phone: +44 207 886 2500
About Faron Pharmaceuticals Ltd
Faron (AIM:FARN) is a clinical stage biopharmaceutical company
developing novel treatments for medical conditions with significant
unmet needs. The Company currently has a pipeline focusing on acute
organ traumas, vascular damage and cancer immunotherapy. The
Company's lead candidate Traumakine, to prevent vascular leakage
and organ failures, is currently the only treatment for Acute
Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical
trials and in 2017 received advice from US FDA to proceed directly
to BLA submission following completion of EU and Japanese Phase III
studies. There is currently no approved pharmaceutical treatment
for ARDS. An additional European Phase II Traumakine trial is
underway for the Rupture of Abdominal Aorta Aneurysm ("RAAA").
Faron's second candidate Clevegen is a ground breaking pre-clinical
anti-Clever-1 antibody. Clevegen has the ability to switch immune
suppression to immune activation in various conditions, with
potential across oncology, infectious disease and vaccine
development. This novel macrophage-directed immuno-oncology switch
called Tumour Immunity Enabling Technology ("TIET") may be used
alone or in combination with other immune checkpoint molecules for
the treatment of cancer patients. Faron is based in Turku, Finland.
Further information is available at www.faron.com
[1] JAMA. 2016 Feb;315(8):788-800
[2] Intensive Care Med. 2011;37(12):1932
[3] N Engl J Med. 2005;353(16):1685
This information is provided by RNS
The company news service from the London Stock Exchange
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