Faron Pharmaceuticals Oy: Recruitment completed in Traumakine INTEREST Trial
December 11 2017 - 7:00AM
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® 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 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
Panmure Gordon (UK) Limited, Nomad and
BrokerFreddy 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
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