As Covid-19 continues to take lives on a daily basis, the search is ongoing for solutions that might prevent, cure or treat the deadly disease. In recent months, some have pointed to cannabis as a possible treatment for severe cases of the Covid-19 – pointing specifically towards the cannabinoid CBD, one of cannabis’ main chemical ingredients. And some research has suggested that this cannabinoid could be helpful.
Now, a synthetic cannabinoid drug, ARDS-003, has been given approval by the FDA to begin phase-1 clinical trials.
ARDS-003 is an injectable drug designed to help with acute respiratory distress syndrome (ARDS), a serious syndrome that occurs in severe cases of the novel coronavirus. This syndrome can be triggered during a cytokine storm, a dangerous over-elevation of cytokines. Cytokines are proteins which signal the body to produce more inflammation. While inflammation is a normal and healthy part of immune responses, when too much of it is produced, it can lead to serious and deadly problems like organ failure and ARDS.
The researchers at Tetra Bio-Pharma, a pharmaceutical company focused on cannabinoid-derived drug discovery and development, created ARDS-003 with the hopes that it could help fight against the ARDS that is common in severe cases of Covid-19. While ARDS-003 isn’t derived from the cannabis plant, as a synthetic cannabinoid, it does modulate the same internal system that cannabis does (called the endocannabinoid system). In particular, ARDS-003 binds to CB2 receptors, one of the two primary receptors in the endocannabinoid system. Importantly, CB2 is a receptor that modulates inflammation and cytokine activity, which could allow it to bring inflammation in ARDS back down to healthy levels. And unlike CB1, which is also activated by cannabis, CB2 doesn’t bring on cannabis’ well-known psychoactive high.
“We have extensive preclinical evidence that the active pharmaceutical ingredient (API) in ARDS-003 has a profound effect in inhibiting the factors that lead to excessive immune system activation” explains Dr. Guy Chamberland, M.Sc. Ph.D., the CEO and Chief of Regulatory Officer at Tetra Bio-Pharma. He says that by targeting the CB2 receptor, the drug will have “the advantage of impacting several pro-inflammatory signaling pathways, enhancing the potency of the drug to rapidly dampen the cytokine release and prevent the extreme outcomes like ARDS, which can be likened to drowning as the lungs fill with fluid.”
While there are currently some drugs that are used to help bring down the extreme inflammation seen in cases of ARDS, Chamberland points out that some “including Remdesivir, do not lower mortality or, like dexamethasone, are only shown to be effective in a small number of patients.”
While many have hung their hopes on a vaccine or antibody treatment to resolve the ongoing coronavirus crisis, those studies are ongoing and there have been some challenges in establishing whether their protection will be long-lasting or work for people of all ages, ethnicities and health conditions. And of course, there are those who may decide not to take the vaccine when it becomes available. Given these factors, Chamberland suggests that “even if a successful vaccine emerges in the next year, the probability of 100% efficacy within the population and the provision of a long-term protective antibody response is unlikely.” Thus, he says that “ pursuing the development of alternative drug products with different therapeutic benefits remains a public health issue.”
The phase 1 study on ARDS-003 is scheduled to begin enrollment in December of 2020, and will consist of a randomized, double-blind, placebo controlled human study. In this first trial, they will test the drug on healthy men and women to confirm it is safe and tolerable and learn more about how it is absorbed and metabolized by the body.
If all goes well with phase 1, they plan to begin phase 2a studies in the second quarter of 2021 to begin to assess safety and tolerability for those with Covid-19. If this phase goes well, Chamberland says they may be able to “allow the release of the drug to physicians making an emergency access type of request through FDA.”
Then in the final phase, Phase 2b/3, which they hope to start by the end of 2021, they will be able to test the efficacy of the drug to alleviate or prevent pulmonary complications like ARDS. Chamberland says that “If the confirmatory phase 2b/3 trial is successful, Tetra will be able to offer governments the first cannabinoid-derived drug with the potential to manage the cytokine storm induced by COVID-19.”
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