Novatek Seeks FDA Emergency Use Authorization after its Oral TQ Formula Significantly Improved Total Symptom Burden in Phase 2 Study of COVID-19 Outpatients

Novatek Seeks FDA Emergency Use Authorization after its Oral TQ Formula Significantly Improved Total Symptom Burden in Phase 2 Study of COVID-19 Outpatients

Novatek Pharmaceuticals announced topline results from the BOSS-Covid-19 study evaluating the efficacy and safety of oral TQ Formula in COVID-19 patients in the outpatient setting. Among other outcomes, oral TQ Formula led to a significantly faster decline in total symptom burden from Day 1 through Day 14, relative to placebo. TQ Formula is a patent-protected oral drug, which represents a fully characterized, enteric-coated formulation of the flowering plant Nigella Sativa, with a specific tight range of thymoquinone (TQ) concentration. Based on the outcome of the BOSS-Covid-19 Study, the FDA has granted Novatek a Type B meeting to consider Emergency Use Authorization (EUA) of oral TQ Formula to treat non-hospitalized COVID-19 patients.

BOSS-Covid-19 was a phase 2 randomized (1:1), double-blind, placebo-controlled study to assess safety and efficacy of the oral drug, TQ Formula capsules versus placebo in treating patients who have tested positive for novel Coronavirus 2019 (COVID-19) in the outpatient setting. Patients were treated at a dose of 500 mg, 3 capsules, two times a day for 14 days from date of randomization. Quantitative viral load as measured by RT-PCR was evaluated...

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