Adamis Pharmaceuticals has reported that the Data Safety Monitoring Board (DSMB) overseeing its Phase II/III clinical trial of Tempol to treat Covid-19, recommended continuation of the study as planned following analysis of interim data.
The meeting of the DSMB was held last month to assess the interim clinical and safety findings from the trial.
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Comprising subject matter specialists, the DSMB can unblind the data to evaluate the effects of the treatment on trial subjects.
The adaptive, double-blind, randomised, placebo-controlled trial is enrolling high-risk patients with early Covid-19 to assess the impact of Tempol versus placebo.
Limiting hospital admission is the trial’s primary endpoint.
The trial intends to enrol nearly 248 Covid-19 patients aged over 18 years.
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By GlobalDataAll the trial subjects will be given the standard of care as part of the study.
Recently, Adamis reported findings from a published study in partnership with Stanford University researchers, where Tempol showed robust and broad in-vitro anti-cytokine activity.
Furthermore, in an animal SARS-CoV2 challenge model, a decline in inflammation was reported in the lungs of animals which received Tempol versus control animals.
Adamis Pharmaceuticals CEO David Marguglio said: “We look forward to the completion and final analysis of this important clinical trial.
“We appreciate the timely feedback from the DSMB as Covid-19 remains a serious public health problem with recent spikes in infections due to omicron and other variants.
“Additional therapeutic options are needed for outpatient treatment of Covid-19.”
The company obtained exclusive global rights under certain patents, patent applications and related expertise linked to Tempol for certain licenced fields including the treatment of respiratory syncytial virus, asthma, influenza and Covid-19.
The field also includes the use of Tempol for lowering radiation-induced dermatitis in people who undergo cancer treatment.
In September last year, Adamis initiated subject dosing in Phase II/III trial of Tempol to treat Covid-19.
