HBC has begun protocol development for its accelerated Phase 2 clinical trial with OmeGo® to decrease Acute Respiratory Distress Syndrome and the need for assisted respiration in COVID-19 patients
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.
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
Dr. Crawford Currie, Medical R&D
Phone: +44 7968 195497
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