Novatek Pharmaceuticals Initiates A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study Of Its Oral Drug, TQ Formula, Against Novel Coronavirus 2019 (COVID-19) In The Outpatient Setting
HOUSTON, Aug. 12, 2021 /PRNewswire/ -- Novatek Pharmaceuticals, INC announced today that the company received FDA approval for its investigational new drug (IND) study; Phase 2 clinical trial for its oral drug, TQ Formula, against Novel Coronavirus 2019 (COVID-19) in the outpatient setting.
HOUSTON, Aug. 12, 2021 /PRNewswire/ -- Novatek Pharmaceuticals, INC announced today that the company received FDA approval for its investigational new drug (IND) study; Phase 2 clinical trial for its oral drug, TQ Formula, against Novel Coronavirus 2019 (COVID-19) in the outpatient setting. The study is currently enrolling patients, with 16 out of 60 patients already randomized with no reported serious adverse events (SAEs) reported, to-date.
This is a randomized, double-blind, placebo-controlled phase II study where participants will be randomized 1:1 and will receive up to 14 days of oral dosing.
This therapy may provide the first potential oral treatment for COVID-19ย different variants, recognizing the global emergency of new SARS-CoV-2 variants, Novatek Pharmaceuticals, Inc. has commenced development of additional pre-clinical experiments against new COVID-19 variants as it is very critical to have access to therapeutic options now and beyond the pandemic.
About TQ Formula
- TQ Formula is an oral GMP-manufactured drug, which represents a concentrated enteric-coated formulation of Nigella Sativa oil, with higher than average thymoquinone concentration.
- In Vitro Viral Studies indicate that TQ Formula blocks the viral entry of SARS-CoV-2 (Covid-19) variants through inhibiting angiotensin converting enzyme 2 (ACE-2).
About the phase 2 study
This is a randomized (1:1), double-blind, placebo-controlled phase 2 study to assess safety and efficacy of the oral drug, TQ Formula (3 g daily dose of enteric-coated Nigella Sativa Oil) capsules versus placebo in treating patients who have tested positive for novel Coronavirus 2019 (Covid-19) in the outpatient setting.
Patients will be 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 will be evaluated at baseline and on days 7 and 14. Covid-19 symptoms will be measured throughout the study using Modified FLU-PRO Plus. Primary endpoint s of the study are:
Study Population: Up to 60 participants will be randomized 1:1 to receive either TQ Formula Capsules + Standard of Care (SOC) or placebo +SOC
Approximately 2-4 centers in the United States
TQ Formula (Nigella Sativa) 500 mg, 3 capsules, BID, taken orally
About Novatek Pharmaceuticals
Novatek Pharmaceuticals, Inc., was recently formed based on years of pre-clinical and preliminary clinical experience with nigella sativa and thymoquinone in different diseases, most recently including pre-clinical anti COVID-19 effects, suggesting that TQ Formula may also have activity against SARS-CoV2. The company will closely manage work sub-contracted to CROs and CDMOs. We have a team of clinically trained professionals with extensive experience in basic and clinical research.
We are a company that focuses on the potentially beneficial roles of TQ against COVID-19 pathophysiology in the context of antioxidant, anti-inflammatory, immunomodulatory, epigenetic modulation, antiviral activity, docking studies on anti-COVID-19 activity, antiviral effects for the treatment of COVID-19.
More information about Novatek can be found at www.novatekpharmaceuticals.com
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