Novatek Pharmaceuticals, Inc., a privately held, clinical-stage biopharmaceutical company, announced topline results from a Phase 2 randomized, controlled multicenter trial (BOSS-Covid-19 study) evaluating the efficacy and safety of oral TQ Formula in COVID-19 patients in the outpatient setting. 
 
The study demonstrated that oral TQ Formula led to significantly faster decline in total symptom burden, defined as duration and severity of symptoms over time from Day 1 through Day 14, relative to placebo.  Additionally, patients treated with TQ Formula showed significant increase from Baseline to Day-14 in cytotoxic CD8-positive T lymphocytes and helper CD4-positive T lymphocytes, and a trend of faster decline in viral load, as compared to placebo. 
 
The significant increase in the central immune cells (CD8 and CD4 cells) suggests that oral TQ Formula is supporting the recovery of the immune system against COVID-19 infection. In addition, oral TQ Formula was very well tolerated as patients treated with the drug experienced no serious adverse events.
 
Based on the outcome of the Study, the FDA has granted Novatek a Type B meeting to consider Emergency Use Authorization of oral TQ Formula to treat non-hospitalized COVID-19 patients.

“We are extremely grateful to our patients who participated in the study, as well as our extraordinary team of investigators who were able to conduct this important multicenter randomized study, during this challenging time,” said Mohamed Kaseb, RPh, chief executive officer of Novatek. “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.”