Reference is made to the stock exchange notice on 26 May 2020 and 30 June 2020. Hofseth BioCare ASA (“HBC”) announces that the first part of its accelerated phase 2 trial of CARDIO™ soft gels for the treatment of patients with COVID-19 respiratory symptoms has been launched as a “virtual trial” in major cities across Ontario. This allows the broadening of the trial to include patients who are currently self-isolating with COVID-19. These patients will participate in the 28-day study via a virtual platform. The trial will be conducted for HBC by the clinical research organization, KGK. The platform allows KGK to interact one-on-one with each participant from the comfort and safety of their homes while adhering to public health guidelines.
This Health Canada approved phase 2 clinical trial will examine the benefit of CARDIO™ soft gels / OmeGo®, in combination with the best standard of care (BSC) in former smokers and/or steroid-resistant asthmatics with COVID-19. This group of patients are at a higher risk of progression to severe acute respiratory distress syndrome (ARDS) with COVID-19 infection. The inflammatory response in the lungs of these patients is typically driven by eosinophils and HBC’s research has identified a minor lipid fraction within OmeGo® that modulates eosinophil effector function.
Participants will be provided with all the equipment and resources needed to complete the study assessments virtually. Some of the planned study outcomes include improvements in daily oxygenation requirements, alleviation of COVID-19 related symptoms, and time to clinical recovery. Clinical status will be assessed by a World Health Organization clinical improvement scale.
KGK is actively recruiting participants in the Greater Toronto Area (GTA), Ottawa, Windsor-Essex County, Waterloo, Hamilton, Niagara, Middlesex-London, Guelph, and Simcoe regions to take part in the research study.
The second part of the study will recruit patients hospitalised with COVID-19, as per the prior stock exchange notices. However, this part of the trial will now be conducted in Brazil and Mexico where hospitalization rates remain high which will enable a timely recruitment schedule. The in-hospital arm is scheduled to begin by late November, pending regional regulatory approvals.
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 of Hofseth BioCare ASA
Phone: +41 79 950 1034
Dr. Crawford Currie, Medical R&D at Hofseth BioCare ASA
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