US pharma gets green light to start human trial for new Covid-19 treatment
A San Diego-based pharmaceutical company has been given the green light to start human trials for a new Covid-19 treatment.
The U.S. Food and Drug Administration (FDA) confirmed today that Adamis Pharmaceutcals may start testing its Tempol drug for the treatment of Covid-19. Earlier studies showed that Tempol reduces inflamation and helps Coronavirus-infected patients early in the infection.
Adamis said in a statement that it plans to examine markers of inflammation and the rate of hospitalization for patients taking Tempol versus placebo early in Covid-19 infection.
Recently, in collaboration with researchers at the Human Immune Monitoring Center at Stanford University, preliminary data showed that Tempol decreased cytokine in stimulated Covid-19 positive human cells.
A so-called cytokine storm is a potentially lethal immune overreaction as a result of a coronavirus infection, which is believed to be responsible for many Covid-related deaths.
Mutations
Dr. Dennis J. Carlo, president and CEO of Adamis Pharmaceuticals, said in a statement this evening: “With new mutations of Covid-19 continuing to occur, there is a distinct possibility that the current vaccines will be less effective. This also holds true for the current antibody products. As the virus continues to mutate, it is likely that this will have a negative impact on viral neutralization.”
He stressed why this highlights how vital it is to develop new therapeutic products.
“The consequences of cytokine storm caused by Covid-19 remain a major burden on our healthcare system, with few treatment options available,” Carlo added.
If the trial is successful, the company plans to petition the FDA to consider Emergency Use Authorization for Tempol as a therapeutic treatment for Covid-19.