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January 11, 2022

Adamis seeks FDA fast-track designation for Tempol against Covid-19

Tempol is being analysed in a double-blind, randomised, adaptive, Phase II/II clinical trial for Covid-19 treatment.

Adamis Pharmaceuticals has submitted an application seeking fast-track designation from the US Food and Drug Administration (FDA) for Tempol to treat and prevent Covid-19. 

Tempol is claimed to possess anti-inflammatory, antiviral and antioxidant activity. 

It is expected to offer an unmet medical need due to its unique mechanism of action and safety profile.

Adamis obtained exclusive global rights of Tempol for specific licensed fields comprising respiratory diseases treatment including asthma, respiratory syncytial virus, influenza and Covid-19.

Presently, Tempol is being analysed in a double-blind, randomised, adaptive, placebo-controlled Phase II/II clinical trial in adult Covid-19 patients. 

The trial intends to enrol nearly 248 participants, who will be categorised into a 1:1 ratio to receive either Tempol or placebo, along with standard of care.

Limiting hospital admission is the primary endpoint of the trial.

Adamis Pharmaceuticals president and CEO Dr Dennis Carlo said: “Concerns have been expressed about potential safety questions for EUA approved antivirals such as mutagenesis and drug-drug interactions.

“We are thus applying for fast-track designation to the FDA to expedite the regulatory approval pathway for Tempol. 

“Because Tempol has both anti-inflammatory and antiviral effects, we believe that Tempol fulfils an unmet medical need as an oral agent, focusing on multiple aspects of the pathogenesis of Covid-19 disease.”

According to data from a study conducted in partnership with Stanford University in the US, Tempol demonstrated robust, wide-ranging in-vitro anti-cytokine activity. 

The company started dosing of participants in Phase II/III trial of the oral antiviral drug candidate, Tempol, to treat Covid-19 in September last year.

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