Speciality biopharmaceutical company Adamis Pharmaceuticals is set to proceed with the Phase II/III study of Tempol (MBM-02) for treating Covid-19.
The latest development follows the completion of a safety review of the company’s Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) and a pre-IND meeting.
The study titled ‘A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Tempol (MBM-02) on Preventing COVID-19 Related Hospitalization in Subjects with COVID-19 Infection’ will evaluate the safety and activity of Tempol in patients in the early stage of the infection.
It will also analyse markers of inflammation and hospitalisation rate of patients receiving Tempol versus placebo early in Covid-19 infection.
The study will enrol high-risk participants with early Covid-19 infection with a primary endpoint of preventing hospitalisation.
The initial Phase II portion of the study will enrol 60 Covid-19-positive individuals with comorbidities. They will be randomly given either Tempol or placebo.
A DSMB will conduct Stage 1 interim analysis to analyse the safety and markers of systemic inflammation.
Based on the DSMB recommendation, the Phase III part of the trial will commence with a second interim analysis after enrolling 150 participants.
Adamis Pharmaceuticals president and CEO Dr Dennis Carlo said: “With new mutations of Covid-19 continuing to occur, there is a distinct possibility that the current vaccines will be less effective.
“We are hopeful that this study will demonstrate the important role of Tempol in treating and preventing hospitalisation and the severe aftereffects of Covid-19.”
On obtaining successful data from the trial, the company intends to seek Emergency Use Authorisation from the FDA for using Tempol as a therapeutic treatment for Covid-19.
The company noted that Tempol has shown both potent anti-inflammatory, anticoagulant, and antioxidant activity.
A study was conducted in partnership with the Stanford University Human Immune Monitoring Center investigators to analyse Tempol’s effects on immune cells from Covid-19 patients.
Preliminary results demonstrated that Tempol lowered cytokine production in stimulated Covid-19-positive human cells.