LUND, Sweden, Oct. 8, 2018 /PRNewswire/ --Encouraged by the
promising discovery study results previously reported, Immunovia´s
prime focus in autoimmunity testing will be to develop IMMray™
blood-based biomarker signatures for the management of rheumatoid
arthritis.
Rheumatoid arthritis (RA) is a devastating chronic autoimmune
disease that affects nearly 7 million people yearly in US and
Europe, and creates an annual
economic burden in the US alone of $19-23 billion, based on direct costs such as
hospitalisation, treatment and loss of productivity. Furthermore,
rheumatoid arthritis symptoms can progress rapidly and with little
advance warning, leading to permanent and debilitating joint
damage. It is crucial that physicians stay ahead of the disease,
since existing treatments can halt or slow down the disease
progression.
However, accurate diagnosis remains a major issue as there are
no tests that can detect all RA cases. To begin with, one of the
biggest clinical problems is that over 25% of the patients with
established RA, unfortunately test negatively for the standard
anti-CCP and anti-RF tests, thus making them very difficult to
diagnose with current methods. Secondly and even more important, in
the early stages of RA, 80% of the patients test negative using the
two current standard tests, reinforcing the need for more accurate
early diagnostic tools. Overall this leads to estimated 3-4 million
test cases in the US and Europe
annually because of the shortcomings of current anti-CCP and
anti-RF tests.
To address this situation Immunovia has completed three
discovery studies to assess IMMray™'s potential in autoimmunity
testing. These have all recently shown promising results. The first
two studies reported excellent accuracy levels using IMMray™ based
signatures for the differential diagnosis of overlapping autoimmune
rheumatic diseases such as RA, Systemic Lupus Erythematosus (SLE),
Sjögren's Syndrome and Systemic Vasculitis (press release
March 7, 2017 and press release
January 12, 2017). This initial study
data has been discussed with numerous Key Opinion Leaders in
autoimmune rheumatic diseases. They all expressed great interest in
the differential data, but they highlighted the need for diagnosis
of early RA. In the RA field, healthcare recommendations for early
diagnosis are already in place1 and ongoing implementation in the
healthcare systems. This strong trend is important for a quick
uptake and market penetration of a diagnostic test that would solve
the bottlenecks described in the recommendations.
The third recently reported discovery study (press release
Aug 22, 2018) showed a major
breakthrough: an accuracy higher than 90% for IMMray™ biomarker
signatures when diagnosing the CCP negative rheumatoid arthritis
patients compared to healthy controls. These exceptionally good
results have now triggered Immunovia's strategic decision to focus
on RA.
For the next step towards developing a commercial product,
Immunovia has started to engage several Key Opinion Leaders in this
field to design and run a study aiming to optimize the signature
for differentiating the patients with early RA from the controls
having other diseases than RA but exhibiting RA-like symptoms.
For SLE, Key Opinion Leaders emphasized that the major clinical
unmet need is monitoring SLE flares and treatment. Preliminary
studies published in 20162showed that IMMray™ platform could
measure SLE high and low activity, but further large discovery
studies with many samples per patient would be required to confirm
these findings.
"As Immunovia has already shown in cancer applications3(press
release Aug 15, 2018), IMMray™ blood
biomarker signatures offer exciting new opportunities to develop
accurate diagnostic tests that could detect the disease in early
stages. Our discovery studies have demonstrated the significant
power of Immunovia´s IMMray™ technology in autoimmune rheumatic
diseases. The overall strategy for Immunovia in the autoimmunity
testing that we have now adopted is to solve major clinical unmet
needs with the main focus on diagnosis of early RA. Our goal is to
provide clinicians with cost-effective multiple testing along the
whole patient pathway – from initial diagnosis through treatment
selection, monitoring and outcome measurement" says Mats Grahn, Immunovia's CEO.
Telephone conference, October 8,
2018
As announced, a telephone conference today at 3:00 – 4:00 p.m
CET will cover Immunovia's autoimmune diseases strategy and be
presented by Mats Grahn, CEO,
Immunovia and Laura Chirica, CCO,
Immunovia. Details in press release dated September 28, 2018.
Reference:
- van Steenbergen HW, et al. Ann Rheum Dis 2016;0:1–6
- Delfani P. et al, Deciphering systemic lupus
erythematosus-associated serum biomarkers reflecting apoptosis and
disease activity, Lupus 26(4) · September
2016
- Mellby L et al, Serum Biomarker Signature-Based Liquid
Biopsy for Diagnosis of Early-Stage Pancreatic Cancer, J Clin
Oncol. 2018 Aug 14. doi: 10.1200/JCO.2017.77.6658.
For more information, please contact:
Mats Grahn
Chief Executive Officer, CEO, Immunovia
Tel.: +46-70-5320230
Email: mats.grahn@immunovia.com
About Immunovia
Immunovia AB was founded in 2007 by investigators from the
Department of Immunotechnology at Lund University and CREATE Health, the Center
for Translational Cancer Research in Lund, Sweden. Immunovia's strategy is to
decipher the wealth of information in blood and translate it into
clinically useful tools to diagnose complex diseases such as
cancer, earlier and more accurately than previously possible.
Immunovia´s core technology platform, IMMray™, is based on antibody
biomarker microarray analysis. The company is now performing
clinical validation studies for the commercialization of IMMray™
PanCan-d that could be the first blood based test for early
diagnosis of pancreatic cancer. In the beginning of 2016, the
company started a program focused on autoimmune diseases
diagnosis, prognosis and therapy monitoring.
(Source: www.immunovia.com)
This information is information that Immunovia AB is obliged to
make public pursuant to the EU Market Abuse Regulation. The
information was submitted for publication, through the agency of
the contact person set out above.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For
more information, please visit www.immunovia.com.
About Rheumatoid arthritis (RA)
Rheumatoid arthritis is a long-term condition that causes pain,
swelling and stiffness in the joints. The
symptoms usually affect the hands, feet and wrists. There may
be periods where symptoms become worse, known as flare-ups or
flares. A flare can be difficult to predict, but with
treatment it's possible to decrease the number of flares and
minimise or prevent long-term damage to the joints. Some people
with rheumatoid arthritis also experience problems in
other parts of the body, or more general symptoms such as
tiredness and weight loss.
Recent studies showed that as many as 51% of patients with
suspected autoimmune or immune disorders are initially
misdiagnosed, in part because of ambiguous laboratory test results.
Clinicians warn that misdiagnosis of systemic autoimmune diseases
can have serious consequences. Currently the gold standard is to
test for anti-cyclic citrullinated peptide (anti-CCP), an
auto-antibody present an estimated 70- 75% of rheumatoid arthritis
patients.
The global market for RA testing is growing strongly and
estimated to reach Euros 2.5 billion
by 2024
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