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article imageNew clinical trial to treat patients with suspected COVID-19

By Tim Sandle     Jun 9, 2020 in Science
The Food and Drug Administration (FDA) has given specialty biotech, FSD Pharma, permission to submit an Investigational New Drug Application (IND) for the use of FSD-201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19.
The test takes the form of a Phase 2a clinical trial study. Phase II of a clinical trial involves several hundred participants who are living with the condition that the new medication is meant to treat. They’re usually given the same dose that was found to be safe in the previous phase.
FSD Pharma reached out the U.S. Food and Drug Administration (FDA )in late-March 2020 after becoming aware that several Italian physicians and scientists were advocating for use of ultramicronized PEA for patients suffering from symptoms of COVID-19. This was based on the drug’s mechanism of action as a potent and safe anti-inflammatory agent that reduces the production of pro-inflammatory cytokines.
A proinflammatory cytokine is a type of signalling molecule (a cytokine) that is secreted from immune cells. The cytokines act as "emergency signals" that bring in your body's immune cells, hormones and nutrients to fix the problem. However, cytokines can also cause harm as part of the process of triggering inflammation.
PEA acts via multiple mechanisms either directly to activate PPAR-α and GPR55 or indirectly through the inhibition of FAAH, which increases endogenous levels of anandamide (AEA) and 2-arachidonoyl-glycerol (2-AG). These endocannabinoids directly activate CB2 (or CB1) receptors and TRPV1 channels (entourage effect). PEA may also activate TRPV1 channels via PPAR-α.
According to lead researcher Dr. Raza Bokhari: "Numerous studies over the past 40 years also validate the efficacy and safety of ultramicronized PEA in the treatment and prophylactic effects in respiratory infections. These studies also pointed out that the ease of application of PEA offers the possibility to have a quick therapeutic answer ready in case of a flu epidemic."
More about Covid19, coronavirus, Patients, Clinical trial
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