Hofseth BioCare investigates salmon oil for easing COVID-19 complications
26 May 2020 --- Hofseth BioCare (HBC) is entering into a Phase 2 clinical trial to assess the ability of OmeGo salmon oil to reduce Acute Respiratory Distress Syndrome (ARDS) related to COVID-19. HBC is currently preparing an investigational protocol with KGK Science, which will then be filed with Health Canada. The trial will use OmeGo in the form of CARDIO, a branded soft gel, on former smokers and steroid-resistant asthma patients who exhibit early non-acute lung injury caused by the SARS-CoV-2 virus. If the initial efficacy data is supportive, the trial can then be scaled to a fully powered Phase 3 study with 600 patients.
“There is a non-omega, minor fraction within OmeGo that suppresses eosinophil function. We could see results [from this trial] within three months or earlier. The timeline depends on the speed at which hospitals can recruit patients. If the trial works, Phase 3 will follow seamlessly,” James Berger, Head of Investor Relations & Strategy at HBC, tells NutritionInsight.
Eosinophils are white blood cells (leukocytes) that form part of the body’s immune system helping to deal with infections. However, Berger notes that in some people, these can become overactivated and cause damage to the body. “This appears to be a key driver of lung inflammation in former smokers. As such, OmeGo brings broad anti-inflammatory and antioxidant effects, with the suppression of eosinophil function appearing the most important in former smokers.”
According to HBC, modulating eosinophil function will reduce the number of patients who will require assisted respiration management. It could also reduce the total number of days on assisted respiration or in Intensive Care Unit (ICU) care.
Last month, KD Pharma and its partner, SLA Pharma, announced that EPAspire – a free fatty acid form of EPA – will be entering clinical trials for COVID-19. Berger explains that in contrast, OmeGo contains all the fractions contained within natural fish oil. “These other fractions also have anti-inflammatory and antioxidant effects,” he explains.
An accelerated trial
CARDIO is the soft gel version of OmeGo, which has previously been proven to reduce oxidized LDL cholesterol by a significant amount. It contains the full spectrum of omega fatty acids, including EPA, DHA and DPA. CARDIO contains minor lipid-soluble components, which can reduce eosinophil effector function (EEF) as well as increasing eosinophil apoptosis (programmed cell death). This has been shown in various in vitro cellular assays at 100 μg per ml concentrations.
“The [element of OmeGo] that suppresses eosinophil function is only contained in whole fish oil and not within processed fish oil, which typically only contain omega 3. Its activity is also damaged by excessive heat, acid and base treatment, so our gentle extraction process is ideal for preserving the activity of the minor fraction. Additionally, our work has also shown that it is not present in krill oil, which is typically the most expensive oil on the market as it costs almost 150 times more to produce,” says Berger.
The 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. All patients, including those in the placebo group, will receive the best current antiviral standard of care. However, the treatment group will also receive CARDIO soft gels. The primary endpoint is the number of days on assisted ventilation.
“We skipped Phase 1 because we have had very successful lab work and the safety and efficacy data has been excellent. Phase 1 is typically a small trial on healthy patients and, given we are in the midst of a global pandemic, we have been granted an accelerated Phase 2 trial now given the circumstances of sick patients,” explains Berger. The trial design also allows scalability for a potential Phase 3. Funding is initially coming from HMC’s existing R&D budget for 2020.
Targeting smoking and asthma
HBC’s decision to target former smokers and steroid-resistant asthma patients is based on findings regarding eosinophils. The recruitment and persistence of eosinophils can trigger lung tissue injury following changes in smoking patterns.
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 the destruction of the respiratory epithelium and the rapid development of acute ARDS.
Meanwhile, HBC notes that overactivity of eosinophils is seen in numerous inflammatory conditions, including eosinophilic asthma. Notably, eosinophils are estimated to be important drivers of asthma in around 40 percent of asthmatics overall and in up to 60 percent of patients with severe asthma.
HBC recently filed a US patent application 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.
Additionally, HBC is set to continue developing a product for treating steroid-resistant asthma in parallel with its COVID-19 clinical trials, progressing toward preclinical animal trials in Q3 2020. Based on a positive outcome, this could then progress to Phase 1 clinical trials in 2021.
Inhaled bronchodilators, called relievers, expand the airways in the lungs. In addition to inhaled corticosteroids, which reduce airway inflammation, the relievers 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, HBC points out that additional treatment options targeting the underlying asthma disease process, especially those delivered orally, would be of significant benefit to patients.
HBC is anticipating profitability this year following the publication of its Q1 financial results. This follows the company “perfecting” its formula for ProGo salmon protein hydrolysate after over a decade of development.
To keep readers informed of these rapid developments, NutritionInsight is updating its daily news feed for the coronavirus-related information and insights you need to guide your business through this challenging period.
By Katherine Durrell
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