Le Lézard
Classified in: Health, Covid-19 virus
Subjects: TRI, FDA

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. 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-19 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

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


SOURCE Novatek Pharmaceuticals

These press releases may also interest you

15 oct 2021
Helix BioPharma Corp. ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, announced today that it anticipates the filing of its annual financial...

15 oct 2021
The Centers for Medicare and Medicaid Services (CMS) released its annual quality rankings. For the 2022 plan year, Network Health earned a 5 out of 5-Star Rating from CMS for its Medicare Advantage PPO plans. This is Medicare's highest possible...

15 oct 2021
Boehringer Ingelheim today announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Cyltezo® (adalimumab-adbm) as the first Interchangeable biosimilar with Humira® (adalimumab). The FDA...

15 oct 2021
Novartis Pharmaceuticals Canada Inc. applauds the government of Quebec's decision to provide public reimbursement for Zolgensma® (onasemnogene abeparvovec)...

15 oct 2021
Worcester Polytechnic Institute (WPI) researcher Loris Fichera has developed a flexible, slimmed-down robotic laser probe for endoscopic larynx surgeries that could reduce recovery time for patients and cut health care spending by shifting procedures...

15 oct 2021
The "Global Industrial Radiography Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Technique (Film-based Radiography and Digital Radiography); End-User Industry" report has been added to ResearchAndMarkets.com's offering. The...

News published on 13 august 2021 at 09:49 and distributed by: