- FSD Pharma received approval from the FDA to apply to run a clinical trial of a cannabis-derived drug on coronavirus patients
- The drug mimics molecules naturally found in marijuana that bind to receptors and play a role in mitigating pain and fighting inflammation
- Researchers believe it mitigates cytokine storms, which occur when the body doesn’t just fight off the virus but also attacks its own cells and tissues
- A Phase I clinical trial studying the drug on patients is currently being performed in Australia
Shares of a cannabis company soared after the US Food and Drug Administration (FDA) granted approval to submit an application for a clinical trial of a weed-derived drug to treat the novel coronavirus.
The synthetic drug, known as ultramicronized palmitoylethanolamide (micro PEA), mimics a molecule found in cannabis and is believed to have anti-inflammatory properties.
Scientists don’t think the medication will kill the virus, but say it may quell a dangerous over-reaction of the immune system.
Upon the news that FSD Pharma, a Philadelphia-based marijuana company, had received approval, shares rocketed by 324 percent on Wednesday morning.
FSD Pharma received approval from the FDA to apply to run a clinical trial of a cannabis-derived drug on coronavirus patients (file image)
Receiving approval to submit an application does not mean the application itself has been approved nor does it mean the drug will soon be available to the general public.
‘The FDA is going to want to see any number of things before that happens,’ Dan Hoffman, a pharmaceutical industry consultant, told The Philadelphia Inquirer.
‘Everything from HIPAA (Health Insurance Portability and Accountability Act) protections to what contractors and testing sites they’re going to use.’
The drug is currently sold in Italy as a prescription for chronic inflammation by pharmaceutical group Epitech Group SpA.
According to The Inquirer, FSD Pharma bought the global license for the drug from Epitech earlier this year for $17.5 million.
CEO Raza Bokhari rebranded the drug as FSD-201.
‘We became aware of it because some Italian health-care providers were advocating the use of micro PEA to treat COVID-19 patients and they were discovering some success,’ he told newspaper.
FSD-201 mimics endocannabinoids, neurotransmitters found in marijuana that bind to CB2 receptors.
These receptors play a large role in the body’s immune system, particularly in mitigating pain and fighting inflammation.
The hope its that FSD-201 could help mitigate a dangerous overreaction to the virus by the body’s immune system called a cytokine storm.
These so-called storms occur when the body doesn’t just fight off the virus but also attacks its own cells and tissues.
In cases of COVID-19, the disease caused by the virus, cytokine storms can trigger respiratory distress.
This can lead to multi-system organ failure and cause the lungs’ airs sacs to fill up with fluid, the result being pneumonia.
‘Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm,’ Bokhari told The Inquirer.
‘[FSD-201] is not a virus killer. But we believe it can mitigate that immune response, which can be fatal.’
A Phase I clinical trial studying FSD-201 is currently being performed in Australia, with confirmed and suspected coronavirus patients receiving the drug.