Hofseth Biocare ASA: HBC has begun protocol development for its accelerated Phase 2 clinical trial with OmeGo® to decrease A...
26 Mai 2020 - 8:00AM
Hofseth BioCare ASA (“HBC”) is preparing an investigational
protocol with KGK Science into Health Canada to conduct a Phase 2
clinical trial assessing OmeGo® in the form of our branded product
CARDIO soft gels as treatment for patients with Acute Respiratory
Distress Syndrome (ARDS) caused by the SARS-CoV-2 virus. The
treatment will focus on Former Smokers and steroid-resistant asthma
patients (“Patients”), who exhibit early non-acute lung injury
caused by the SARS-CoV-2 virus. Publications from the US Centers
for Disease Control and Prevention (CDC), Chinese CDC and Italian
CCM show Former Smokers to be at particularly high risk for
COVID-19-based ARDS progression into ICU care.
HBC’s single-center, randomized, placebo-controlled trial aims
to slow the progression of ARDS in 100 Patients with confirmed
SARS-CoV-2 infection who exhibit early pulmonary symptoms. The
Patients will receive the best current antiviral standard of care
(BSC) in the placebo arm and BSC+CARDIO soft gels in the treatment
arm. The primary endpoint is the number of days on assisted
ventilation. Based on previous study data on efficacy, dosing and
safety, this study will be an accelerated phase 2 trial. The trial
design will also enable it to be scaled into a fully powered Phase
3 study with 600 Patients if the initial efficacy data is
supportive. The trial is being initially funded from HBC’s existing
R&D budget for 2020.
CARDIO soft gels contain minor lipid-soluble components that
have been shown to reduce eosinophil effector function (EEF) and
increase eosinophil apoptosis (programmed cell death) in various
invitro cellular assays at 100 ug/ml concentrations. HBC believes
that modulating eosinophil function will reduce the number of
Patients who will require assisted respiration management as well
as reduce the total number of days on assisted respiration/ICU
care.
Eosinophils are white blood cells (leukocytes) which form part
of the body’s immune system helping to deal with infections.
Changes in smoking patterns can trigger lung tissue injury via the
recruitment and persistence of eosinophils. According to the
American Lung Association analysis of CDC data, there are currently
in excess of 55 million former smokers vs. approx. 34 million
current smokers in the US. In former smokers, bilateral
ground-glass opacities on CT-scan images are visible which appear
to be similar to the CT lung images of COVID-19 patients. Mistimed
and uncontrolled eosinophil production in lung epithelial cells
plays a critical role in destruction of the respiratory epithelium
and rapid development of acute ARDS.
HBC has also recently filed a US patent application (630063274
04/07/2020) on minor components in OmeGo® salmon oil that
significantly attenuate respiratory eosinophilic inflammation, as a
treatment for the management of asthma, particularly
steroid-resistant asthma.
Overactivity of eosinophils is seen in numerous inflammatory
conditions including eosinophilic asthma. According to US CDC,
about 7-8 % of the US population suffers from asthma and it is a
condition that has been increasing since the early 1980s in all
age, sex and racial groups. Eosinophils are estimated to be
important drivers of asthma in around 40 % of asthmatics overall
and in up to 60 % of patients with severe asthma. Inhaled
bronchodilators (“relievers”), which expand the airways in the
lungs, and inhaled corticosteroids, which reduce airway
inflammation, are a mainstay of asthma treatment. However, a
significant number of patients still suffer from asthma symptoms
and exacerbations and are commonly referred to as steroid-resistant
asthma patients. As such, additional treatment options targeting
the underlying asthma disease process, especially those delivered
orally, would be of significant benefit to patients.
HBC will continue to develop a product for treating
steroid-resistant asthma in parallel with its COVID-19 clinical
trials, progressing towards preclinical animal trials in Q3 2020
and based on a positive outcome, progressing to Phase 1 clinical
trials in 2021.
About OmeGo®
OmeGo® contains the full spectrum of omega fatty acids including
EPA, DHA and DPA offering benefits on human cholesterol levels
including reduction of the CVD biomarker, oxLDL-GP1, for which HBC
has global patent rights. Only OmeGo® contains all the
lipid-soluble compounds found in fresh salmonid fish thus providing
all of the health benefits seen when consuming an oily fish-based
diet. HBC uses its proprietary enzymatic hydrolysis technology to
sustainably extract all the nutrients from the fish and transforms
them into high value health products for human and pet
consumption.
For further information, please contact:
James Berger, Head of Investor Relations & Strategy Phone:
+41 79 950 1034 E-mail: jb@hofsethbiocare.no
Dr. Crawford Currie, Medical R&D Phone: +44 7968 195497
E-mail: cc@hofsethbiocare.no
About Hofseth BioCare ASA:
HBC is a Norwegian biotech company that develops high-value
ingredients and finished products. The ingredients are in various
stages of discovery and preclinical development in collaboration
with multiple clinics and university research labs in several
countries. Lead preclinical and clinical candidates are in
development toward treatment for iron-deficiency anemia,
gastro-Intestinal Inflammation (NEC/IBS/UC), prediabetes,
age-related sarcopenia and osteoarthritis.
The company is founded on the core values of sustainability,
traceability and optimal utilization of natural resources. Through
an innovative hydrolysis technology, HBC can preserve the quality
of lipids, proteins and calcium from fresh salmon off-cuts. Hofseth
BioCare's headquarters are in Ålesund, Norway with branches in
Oslo, London, Zürich, Chicago, Menlo Park and Tokyo. HBC is listed
on Oslo Stock Exchange Axess list with ticker "HBC". More
information about Hofseth BioCare at hofsethbiocare.com and
facebook.com/hofsethbiocare
This information is subject to the disclosure requirements
pursuant to Section 5-12 of the Norwegian Securities Trading
Act