Novatek seeks EUA after its Oral TQ Formula Significantly improved Total Symptom Burden in a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of COVID-19 Patients in the Outpatient Setting
The United States Food and Drug Administration (FDA) has granted a meeting with Novatek to consider Emergency Use Authorization (EUA) of TQ Formula to treat non-hospitalized COVID-19 patients
HOUSTON, Nov. 1, 2021 /PRNewswire/ -- Novatek Pharmaceuticals, Inc. ("Novatek") a privately held, clinical-stage biopharmaceutical company today 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 (p=0.006), 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 (p=0.038) and helper CD4-positive T lymphocytes (p=0.025), and a trend of faster decline in viral load (p=0.18), as compared to patients treated with 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 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.
"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."
About the BOSS-COVID-19 study
The BOSS-COVID-19 (clinicaltrials.gov identifier: NCT04914377) trial was a national multicenter study in the United States, randomized (1:1), double-blind, placebo-controlled phase 2 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 at baseline, and on days 7 and 14. Covid-19 symptoms were measured throughout the study (Day 1 through Day 21) using Modified FLU-PRO Plus. Inclusion criteria included: age 18 and over, presentation with recent mild to moderate clinical symptoms of COVID-19 infection, positive COVID-19 infection confirmed with a rapid antigen test at screening (or RT-PCR within the last 3 days) and confirmed with a RT-PCR test at baseline, and a score of ³ 3 on a minimum of 2 symptoms on the Modified FLU-PRO Plus. For more information about the BOSS-COVID-19 study, please visit clinicaltrials.gov.
About TQ Formula
TQ Formula is a patent protected oral drug, which represents a fully characterized, enteric-coated formulation of Nigella Sativa, with specific tight range of thymoquinone (TQ) concentration. In vitro viral studies demonstrated TQ Formula blocks the viral entry of multiple SARS-CoV-2 (COVID-19) variants through inhibiting angiotensin converting enzyme 2 (ACE-2).
About Novatek Pharmaceuticals
Novatek was established to investigate the use of derivatives from nigella sativa and its key active ingredient thymoquinone (TQ) in various diseases, including COVID-19, based on years of preclinical and preliminary clinical experience. Novatek is composed of clinically trained professionals with extensive experience in basic and clinical research. To learn more please visit www.novatekpharmaceuticals.com
Media Contact:
Ashley Ludtke
[email protected]
(877) 666-8283, Ext. 7
Investor Contact:
Osama Kasseb, RPh
[email protected]
(877) 666-8283, Ext. 5
SOURCE Novatek Pharmaceuticals
Share this article