Hofseth Biocare ASA: HBC starts its accelerated COVID-19 Phase 2 clinical trial of OmeGo® salmon oil to decrease Acute Respiratory Distress Syndrome and the need for assisted respiration

Reference is made to the stock exchange notice on 26 May 2020 and Hofseth BioCare ASA (“HBC”) announces that Health Canada has approved its accelerated phase 2 investigational trial protocol of CARDIO soft gel treatment for patients with Acute Respiratory Distress Syndrome (ARDS) caused by the SARS-CoV-2 virus. The trial will immediately begin recruiting patients from Greater Toronto based hospitals including Mount Sinai Hospital, Toronto.

The trial will recruit 100 former smokers and steroid-resistant asthma patients (“Patients”), who exhibit early non-acute lung injury caused by the SARS-CoV-2 virus. As noted previously, publications from the US 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 randomized, placebo-controlled trial will aim to slow the progression of ARDS in 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 will measure reduction in requirement for assisted respiration.

An interim analysis will be performed after the first 30 Patients complete treatment. With a planned treatment duration of 15 days, an initial data read-out from the first part of the trial is anticipated within 12 weeks of the first patient goes on treatment. The trial is being initially funded from HBC’s existing R&D budget for 2020.

HBC’s ongoing research has shown that the OmeGo® salmon oil present in the CARDIO soft gels contain lipid-soluble components that reduce eosinophil effector function (EEF) and increase eosinophil apoptosis (programmed cell death). These results have been validated in various invitro cellular assays at 100 ug/ml concentrations as well as animal model work at differing doses (g/kg) of OmeGo® oil. HBC believes that modulating eosinophil function, along with the other anti-inflammatory and antioxidant properties of OmeGo®, 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. 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 recently announced the filing of 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. About 7-8% of the population suffer from asthma. 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. A large scientific and clinical evidence base has identified the white blood cells and related cytokines responsible for initiating and sustaining bronchial inflammation in different subtypes of asthma. As such, eosinophilic asthma is an ideal setting to test the potential benefit of the minor fraction within OmeGo® in terms of improved lung function, reduced exacerbation rates and even potentially reduced steroid usage.   

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 at Hofseth BioCare ASA

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E-mail:

Dr. Crawford Currie, Medical R&D at Hofseth BioCare ASA

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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 the Norwegian Securities Trading Act