Faron Pharmaceuticals Oy: Interim Results for the six months ended 30 June 2017
September 06 2017 - 7:01AM
Faron Pharmaceuticals Ltd("Faron" or the
"Company")
Interim Results for the six months ended 30
June 2017
- INTEREST Phase III Traumakine® trial patient recruitment to
complete in Q4 2017 and FDA advice received regarding advancement
to BLA
- Traumakine clinical development broadened to include organ
protection opportunities
- Clevegen® advancing towards clinic
TURKU - FINLAND, 6 September 2017 - Faron
Pharmaceuticals Ltd ("Faron") (LON: FARN), the clinical stage
biopharmaceutical company, today announces its unaudited Interim
Results for the six months ended 30 June 2017 (the "Period").
HIGHLIGHTS
Operational (including post
period-end)
- Pipeline progress with portfolio of products focused on
acute organ traumas, vascular damage and cancer
immunotherapy
- Traumakine - lead product in late Phase III with opportunity
to become world's only approved ARDS treatment
- Pivotal, pan-European, Phase III INTEREST trial with Faron's
lead product Traumakine for the treatment of Acute Respiratory
Distress Syndrome ("ARDS") continues as planned and is expected to
complete recruitment of the targeted 300 patients during the fourth
quarter of 2017.
- Faron announced plans to initiate a program for compassionate
use of Traumakine treatment once the trial is closed to new
patients.
- FDA proposal to proceed directly to BLA submission for
Traumakine® upon completion of European and Japanese Phase III
studies following successful discussions with the Agency as
announced 4 September 2017.
- Collaboration was initiated with INC Research/inVentiv Health -
a global biopharmaceutical solutions organization with end-to-end
clinical development and commercialization capabilities - to
develop the pre-launch commercialization strategy for
Traumakine.
- Japanese partner Maruishi continues to progress their pivotal
Phase III ARDS trial in Japan and has received two IDMC
recommendations to continue the trial as planned. Maruishi
anticipates completion of recruitment in this 120 patient study
during H1 2018.
- Formulation patent granted in Finland and filed in the US and
PCT for Faron's IV dose form of interferon-beta.
- First patient enrolled in February in the Phase II INFORAAA
clinical trial of Traumakine for the treatment of Multi-Organ
Failure (MOF) and mortality prevention of surgically operated
Ruptured Abdominal Aorta Aneurysm (RAAA).
- INFORAAA program open at five sites in Finland with three to
four more planned in Estonia and Lithuania in the near future;
filing in progress to open three to four sites in the
UK.
- Clevegen - wholly-owned novel cancer immunotherapy in
development
- Preclinical toxicity studies commenced as planned following
successful production of technical batches of Clevegen by
manufacturing partner Abzena.
- Agreement signed with the University of Birmingham Medical
School, UK, to initiate a liver cancer clinical trial program,
focused on the protocol design for a Phase I/II trial.
- Initiated protocol design to treat melanoma, pancreas and
ovarian cancer with Clevegen and to be submitted to the Finnish
regulatory authority, FIMEA, later this year.
Financial
- Raised approximately £5.0 million before expenses through a
placing of 1,422,340 Ordinary Shares at an issue price of 350 pence
per share in March 2017.
- Cash balances of €10.3 million (2016: €8.9 million) at 30 June
2017 aided by prudent cost control.
- Operating loss of €7.2 million (2016: €3.0 million) for the six
months ended 30 June 2017.
- Net assets of €9.5 million (2016: €7.7 million) on 30 June
2017.
Corporate
- Dr Juho Jalkanen was appointed as Vice President of Business
Development in April and stepped down from the Board in May.
- Two new Board members, Dr Gregory Brown and Mr John Poulos,
with significant global networks, were appointed as Non-Executive
Directors in May.
Commenting on the results, Dr Markku
Jalkanen, CEO of Faron, said: "Our aim is to build Faron into a
global business dedicated to addressing areas of significant unmet
need, utilising the opportunities contained within our wholly owned
pipeline of novel drug candidates. The Truamakine Phase III
INTEREST study for ARDS completed two further independent safety
reviews and is approaching completion of recruitment in Q4 2017. We
are looking forward to the data readout, which if favourable, will
pave the way for our first commercial launch of Traumakine. We were
further encouraged by the FDA's recent proposal to allow Traumakine
to proceed directly to BLA submission upon completion of the
European and Japanese trials and which will likely result in a
faster and cheaper route to market in the US in the event of
positive data.
"Beyond ARDS, we believe that Traumakine has
excellent potential for application in other areas of organ
protection. Impairment of endothelial barrier can be a reason for
many organ dysfunctions. We are currently exploring its efficacy in
addressing Multi-Organ Failure and mortality in patients with
surgically operated Ruptured Abdominal Aorta Aneurysm (RAAA)
through a Phase II trial.
"We are also pleased to have made substantial
progress with our novel cancer immunotherapy candidate Clevegen,
which works to remove immune suppression around tumours caused by
tumour associated type-2 macrophages (TAM). Following the
development of our new TIET platform and the commencement of
preclinical toxicity studies we are now preparing to embark upon an
extensive clinical program to investigate this promising candidate.
In addition to its potential application in oncology, we are
excited by Clevegen's potential application in a broader range of
indications including chronic infections and vaccination
enhancement."
For more information please contact:
Faron Pharmaceuticals LtdDr Markku Jalkanen, Chief
Executive Officerinvestor.relations@faron.com
Consilium Strategic CommunicationsMary-Jane Elliott,
Chris Welsh, Philippa Gardner, Lindsey NevillePhone: +44 (0)20 3709
5700E-mail: faron@consilium-comms.com
Westwicke Partners, IR (US)Chris BrinzeyPhone: 01 339 970
2843E-Mail: chris.brinzey@westwicke.com
Cairn Financial Advisers LLP, Nominated AdviserEmma Earl,
Tony RawlinsonPhone: +44 207 213 0880
Panmure Gordon (UK) Limited, Joint
BrokerFreddy Crossley, Duncan Monteith (Corporate Finance)Tom
Salvesen (Corporate Broking)Phone: +44 207 886 2500
Whitman Howard Limited, Nominated BrokerRanald
McGregor-Smith, Francis NorthPhone: +44 207 659 1234
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. 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
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