Adamis Pharmaceuticals has commenced dosing of subjects in Phase II/III clinical trial of an oral antiviral drug candidate, Tempol, for the treatment of Covid-19.
The adaptive, randomised, double-blind, placebo-controlled Phase II/III trial will enrol nearly 248 unvaccinated participants with early Covid-19 aged 18 years or above and at increased risk.
Subjects will be enrolled within five days of infection and must have a minimum of one co-morbidity such as hypertension, diabetes, obesity, cancer, chronic renal disease or immunodeficiency.
The participants will be randomised in a 1:1 ratio to receive twice-daily doses of either 400mg Tempol or placebo for up to 21 days.
The rate of hospitalisation in the Tempol group compared to the placebo arm will be the trial’s primary goal.
Adamis noted that the Phase II segment will have 50 participants.
The data and safety monitoring board (DSMB) will carry out an interim analysis to assess the safety and systemic inflammation markers during a stage one interim analysis.
Based on the panel’s recommendation, the Phase III segment of the trial will enrol 198 subjects and a second interim analysis will be conducted on enrolling 124 subjects.
Furthermore, a comprehensive safety evaluation will be carried out and all drug-related adverse events will be reported, assessed and compared for the Tempol and placebo arms.
Adamis Pharmaceuticals president and CEO Dr Dennis Carlo said: “We are pleased to begin patient dosing in this Phase II/III clinical trial for Tempol, which has demonstrated highly encouraging preclinical data in several disease models of infection and inflammation.
“If approved, Tempol may not only prove to be a very important drug for the treatment of Covid-19, but it may also play a role in curbing the pandemic.”
Tempol was demonstrated to have antiviral, anti-inflammatory and antioxidant activity in preclinical studies.
The US National Institutes of Health (NIH) recently noted the potential of Tempol as at-home therapy for Covid-19, Adamis said.
The NIH scientists had found that SARS-CoV-2 requires clusters of iron and sulfur minerals for replication in cells. Tempol can potentially destruct these clusters and hinder the virus multiplication, thereby averting severe disease.
At the start of this year, Adamis submitted an investigational new drug application to the US Food and Drug Administration for the use of Tempol to treat Covid-19.