Novatek Pharmaceuticals has sought emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its oral TQ Formula to treat Covid-19-infected individuals in the outpatient setting.
A completely characterised, enteric-coated formulation of Nigella Sativa, TQ Formula has a particular thymoquinone concentration range.
The company noted that the FDA agreed to a Type B meeting to consider EUA for the oral drug.
The latest move comes after Novatek reported positive data from a placebo-controlled, randomised, multicentre Phase II BOSS-Covid-19 clinical trial of oral TQ Formula to treat non-hospitalised subjects.
Carried out in the US, the trial analysed the safety and efficacy of the drug against placebo in adult subjects aged 18 years or above with mild to moderate Covid-19 symptoms.
Subjects were given either three 500mg capsules of the drug twice a day or a placebo for 14 days.
Findings showed that the oral treatment offered a substantially quicker reduction in total symptom burden as against placebo.
Subjects in the treatment arm had a greater surge in cytotoxic CD8-positive T lymphocytes and helper CD4-positive T lymphocytes from baseline to day-14 versus placebo.
Furthermore, a trend of quicker viral load decline on receiving oral TQ Formula was reported.
The rise in the CD8 and CD4 central immune cells indicates that the treatment potentially aids in the recovery of the immune system from Covid-19.
In the trial, the drug was demonstrated to be well-tolerated without any serious adverse events observed.
Novatek CEO Mohamed Kaseb said: “Building on our initial pre-clinical studies, which indicated that TQ Formula blocks the viral entry of all variants Covid-19, we are pleased to report this topline data that will aid the current global efforts to combat the Covid-19 pandemic.”