Cardax seeks collaboration on astaxanthin for COVID-19

24 Mar 2020 --- US-based Cardax is seeking strategic collaborations to develop astaxanthin for the treatment of COVID-19. A new white paper from the biopharmaceutical company lays out the potential role of the carotenoid in fighting the pandemic. According to Cardax, astaxanthin may hold promise for boosting the immune system and reducing the extreme inflammatory response that may lead to severe respiratory complications in subjects with COVID-19. However, the move has been met with caution from other companies in the space, who warn that the proposal could be “premature.”

“We are looking to collaborate with academic hospitals, government agencies, and pharmaceutical and biotech companies who are or will be conducting clinical trials in COVID-19 subjects. Our goal would be to test the ability of our commercially available astaxanthin dietary supplement ZanthoSyn to impact the inflammation associated with the ‘cytokine storm’ theorized to play a major role in COVID-19 morbidity and mortality,” David Watumull, President & CEO of Cardax, tells NutritionInsight.

He explains that ZanthoSyn is already commercially available and does not need any further development to be used in a clinical trial setting. “Regulatory steps such as an IND and IRB approval would, of course, have to be addressed, but a collaborator may have these in place,” he states. The company has also filed a patent application related to the potential role of astaxanthin in the treatment of COVID-19.

Scientific rationale
The COVID-19 disease is caused by infection of the novel coronavirus (SARS-CoV-2). COVID-19 is an extreme immune response characterized by the overproduction of immune cells and the uncontrolled release of pro-inflammatory cytokines, as detailed in Cardax’s white paper entitled Astaxanthin: A safe, natural, and multi-faceted anti-inflammatory for maintaining lung health and possibly minimizing SARS-CoV-2 effects. 

High levels of certain cytokines lead to overt inflammatory symptoms that include mild to severe respiratory disease, high fever and coughing. In progressed disease, this “cytokine storm” will circulate throughout the body to trigger a surge of active immune cells into the lungs resulting in acute lung injury and acute respiratory distress syndrome. 

Cardax argues that the association between infection and progression of the disease with inflammation suggests a strategy that would partner anti-infective agents, such as antivirals and vaccines, with anti-inflammatory agents. The anti-inflammatory agent could mitigate symptoms, as well as stemming the immune over-response if initiated at an early stage of disease progression. 

“Astaxanthin is exceptionally safe and we do not expect any safety issues, but safety has not been tested in the COVID-19 population. The anti-inflammatory impact of astaxanthin in COVID-19 is not known, and the clinical studies we seek should clarify its potential anti-inflammatory properties in this population, if any,” explains Watumull.

Astaxanthin has been shown to decrease levels of pro-inflammatory cytokines IL-1, IL-6, TNF-α and C-Reactive Protein (CRP) in multiple models of disease in various pre-clinical and clinical studies, according to Cardax. It also does not lead to abnormal immune suppression even at high doses and acts to restore healthy immune homeostasis.

Additionally, results from the interim review of the company’s ongoing CHASE (Cardiovascular Health Astaxanthin Supplement Evaluation) clinical trial demonstrated a statistically significant reduction in CRP, which is a measure of inflammatory health, in diabetics and a strong trend of CRP reduction in cardiovascular subjects.

While pharmaceutical care is the crucial element of fighting COVID-19, some members of the nutrition industry are looking inward to see if they might be able to offer insights. Earlier this month, Australian biotechnology company Marinova, highlighted that it has previously examined the effect of fucoidan – bioactive seaweed compounds – on coronaviruses. 

Solid scientific evidence can only come from thoroughly planned and executed clinical studies.Lukewarm reaction
Despite Cardax’s hopes for astaxanthin being a potential COVID-19 treatment pathway, other movers in the space are more restrained. “It is premature to propose astaxanthin – or any other nutraceutical – as a potential ingredient in the fight against COVID-19 without solid scientific evidence. AstaReal will continue supporting clinical studies that may include exploring natural astaxanthin’s potential in the areas of anti-inflammatory and immune support,” Peter Worsöe, AstaReal Sweden’s CEO, tells NutritionInsight.

He also stresses that solid scientific evidence can only come from thoroughly planned and executed clinical studies, and such studies take time. However, he notes that natural astaxanthin has also been shown to be a powerful anti-inflammatory and there is ample evidence for astaxanthin supporting immune responses in vitro or in animal models.

Meanwhile, Israel-based NextFerm is also investigating the astaxanthin-coronavirus link, with Dr. Tzafra Cohen, Vice President of R&D, telling NutritionInsight how astaxanthin supports the immune system through several pathways. 

“There is a great deal of accumulating evidence. This includes how astaxanthin increases antibodies formation and enhances the body’s ability to fight against the viral infection. Astaxanthin was also shown to increase IgA secretion in the nasal and oral mucosa and therefore, to reduce the initial risk as of exposure to both nasal and mouth infection,” Dr. Cohen states. 

While Algatech is not looking into developing an astaxanthin-based pharmaceutical, a spokesperson notes that natural astaxanthin has a strong safety record. This in combination with known health benefits mean it could be a candidate for medical research, the spokesperson states.

Worsöe adds that continued research will show even more benefits. “AstaReal is the most clinically studied brand of natural astaxanthin with a portfolio of more than 60 human clinical trials. These studies have demonstrated that natural astaxanthin works at the cellular and mitochondrial levels to provide a range of benefits for the eyes, skin, muscles and cognitive function.” 

He continues that the natural ingredient industry plays an important role in promoting good health and well-being through preventative measures. “However, given the current global situation, we believe it is also critical that we act responsibly and encourage everyone to heed the advice of their local governments, health authorities and healthcare professionals.”

Earlier this month, the European Food Safety Authority (EFSA) reaffirmed its 2017 authorization of the use of astaxanthin-rich oleoresin from Haematococcus pluvialis microalgae in food supplements at levels of up to 8 mg per day. However, researchers have flagged that there is still a lack of safety parameters around synthetic astaxanthin. 

By Katherine Durrell