Respiratory Research Program

Fast track Covid-19 research program:

  • Fast track approval for a therapeutic clinical study in collaboration with the Canadian research institute KGK Science, and Mount Sinai University Hospital in Toronto
  • 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
  • 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

Steroid treatment resistant Asthma research program

  • Ongoing research program on steroid treatment resistant asthma which is modulated by eosinophil dysfunction.
  • Individual Investigator Protocol for clinic based short term biomarker trials under preparation.
  • Animal model with house dust mite induced allergy under study.

Treatment of Covid19
The Covid19-pandemic has changed the framework for research on respiratory diseases. Traditional processes are suspended or fast forwarded.

OmeGo®, has already been approved as nutrition, and is thus considered safe to consume. To be tested as medicine, the regulatory authorities also need convincing evidence of the potential benefit. Based on initial feedback from regulatory authorities, and medical researchers with an expertise on eosinophils, it seems very likely that the protocols will be approved in all relevant countries.

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.

Treatment of asthma
Approximately 5 percent of asthma patients suffer from eosinophilic malfunction. We 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.

Eosinophils are a certain form of white blood cells (leukocytes) which form part of the body’s immune system, helping to deal with infections. In some patients, over-activity of eosinophils is seen in numerous inflammatory conditions, including eosinophilic asthma. In these patients, the body is over-expressing an immune-response, and the cells supposed to help rid the body of disease, becomes the cause of the disease.

In lab-studies, OmeGo®, our fresh, unprocessed salmon oil, is found to affect the regulation of eosinophils. This indicates that one or more compounds in our oil can modulate the eosinophil function.

If those assumptions prove correct, intake of OmeGo® will reduce the number of patients who will progress from mild to moderate to severe ARDS during SARS-CoV-2 infection thereby reducing the strain on public health services during a pandemic.

If the ongoing clinical trial on OmeGo® proves to have a significant effect, the next step will be to isolate the specific compound(s) that impact the regulation of the eosinophils. These compound(s) would become leads towards a pharmaceutical drug development program. It is noteworthy that this bio-activity is not present in 18/12 oils or other processed or distilled fish oils.