Faron Pharmaceuticals Oy Recruitment completed in Traumakine INTEREST Trial (9280Y)
11 December 2017 - 6:32PM
UK Regulatory
TIDMFARN
RNS Number : 9280Y
Faron Pharmaceuticals Oy
11 December 2017
Faron Pharmaceuticals Ltd
("Faron" or the "Company")
Recruitment completed in Traumakine INTEREST Trial
The upcoming read-out will collate intact 90 day
morbidity/mortality data alongside 28 day mortality data as
requested by the study IDMC
Phase III INTEREST top line results expected in H1 2018
TURKU - FINLAND, 11 December 2017 - Faron Pharmaceuticals Ltd
("Faron") (AIM: FARN), the clinical stage biopharmaceutical
company, announces that it has completed recruitment, on track, for
its Phase III INTEREST trial of Traumakine(R) for the treatment of
moderate to severe Acute Respiratory Distress Syndrome (ARDS).
In addition to the completion of recruitment, the Company
reports that it has adopted recommendations from the INTEREST
trial's Independent Data Monitoring Committee (IDMC) and Steering
Committee (SC) to present patient data showing blinded ARDS
outcomes (mortality/morbidity) at 90 days (D90), in addition to the
day 28 (D28) mortality endpoint. Outcomes at D90 are widely
recognised to be as important clinically when judging the benefit
of treatment alongside the D28 data. This recommendation was made
following the FDA's recent proposal for Faron to proceed directly
to BLA filing for Traumakine in the US using data obtained from the
European and Japanese trials. The Company expects therefore that
the INTEREST top-line data from the trial will become available in
H1 2018 following collation of the D90 data. Faron's Japanese
partner Maruishi also expects Japanese phase III results in
2018.
The INTEREST trial is a Phase III double-blind, randomised,
parallel-group comparison of efficacy and safety of Traumakine
(FP-1201-lyo) and placebo in the treatment of patients with
moderate to severe ARDS. The study, which has successfully
recruited its target of 300 patients, is currently being conducted
in more than 60 hospital intensive care units (ICU) in Belgium,
Finland, France, Germany, Italy, Spain, UK and Czech Republic. The
key efficacy endpoint in the INTEREST trial is the all-cause
mortality rate at day 28. The INTEREST trial protocol is targeting
a 50% reduction in all cause mortality at day 28 between placebo
and treatment arm (from 30% down to 15%).
ARDS is a severe orphan disease with a reported mortality rate
of approximately 30-45%, 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 with around 300,000 plus annual cases in
Europe and US alone.
Dr Markku Jalkanen, CEO of Faron, said: "We are extremely
pleased to have completed recruitment for the INTEREST study within
our expected timelines and are grateful for all parties involved in
reaching this milestone. Closing the recruitment marks another
important step for Traumakine and Faron. Our focus is now on
closing the data basis for read-out purposes and bringing this
product to the market as expediously as possible in order to
provide patients with this life threathening condition a treatment
option where currently there is none."
Professor Geoff Bellingan from the University College London
Hospital and the Co-principal Investigator of the INTEREST trial,
added: "All of us who have been involved with this study have
shared the excitement of the INTEREST trial as it offers the
potential to finally have an effective pharmacological treatment
for ARDS patients. We fully support the advice from the IDMC and SC
to hold reporting results until we have both D28 and D90 data as
this offers the ideal non-biased means of protecting the data
integrity for regulatory purposes. We are aware that the FDA, in
particular, has appreciated the inclusion of D90 survival data
alongside the D28 endpoints. Given the need for this treatment for
our patients, we now look forward to completing the data
verification and presenting top line results in the first half of
2018."
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
This information is provided by RNS
The company news service from the London Stock Exchange
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