NOVATEK PHARMACEUTICALS

Pipeline

1. CLINICAL TRIAL:

"To Evaluate the Safety and Efficacy of TQ Formula in Covid-19 Participants"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read Clinicaltrals.gov’s disclaimer for details.

Brief Summary:

This is a randomized (1:1), double-blind, placebo-controlled phase 2 study to assess safety and efficacy of Total TQ Formula (3 g daily dose of 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.

Detailed Description:

Study Population: Up to 60 participants will be randomized 1:1 to receive either TQ Formula Capsules + Standard of Care (SOC) or placebo +SOC

  • Phase: Phase II
  • Approximately 2-4 centers in the United States
  • TQ Formula (Nigella Sativa) 500 mg, 3 capsules, BID, taken orally
  • Study Duration: 6 months
  • Participant Duration: Up to 45 days
 

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.

Study Design:

Study Type :Interventional  (Clinical Trial)
Estimated Enrollment:60 participants
Allocation:Randomized
Intervention Model:Parallel Assignment
Intervention Model Description:This is a randomized, double-blind, placebo-controlled phase II study to assess the safety and efficacy of TQ Formula versus placebo in the treatment of Covid-19 in an outpatient setting. Participants will be randomized 1:1 to receive either 3 g per day of TQ Formula or placebo (identical in appearance). The participants will receive up to 14 days of dosing.
Masking:Double (Participant, Investigator)
Masking Description:Double-blind study
Primary Purpose:Treatment
Official Title:A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of TQ Formula in Treating Participants Who Have Tested Positive for Novel Coronavirus 2019 (BOSS-Covid-19)
Actual Study Start Date:June 8, 2021
Estimated Primary Completion Date:July 2021
Estimated Study Completion Date:October 2021
 

Study Design:

Study Type :Interventional  (Clinical Trial)
Estimated Enrollment:60 participants
Allocation:Randomized
Intervention Model:Parallel Assignment
Intervention Model Description:Click to view
Masking:Double (Participant, Investigator)
Masking Description:Double-blind study
Primary Purpose:Treatment
Official Title:Click to view
Actual Study Start Date:June 8, 2021
Estimated Primary Completion Date:July 2021
Estimated Study Completion Date:October 2021
 

2. PENDING CLINICAL TRIAL:

"To combine TQ formula to immunotherapy in neuroendocrine carcinoma, in collaboration with Case Western Reserve University, UH Seidman Cancer Center"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read Clinicaltrals.gov’s disclaimer for details.

3. NOVATEK PRESS RELEASE

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

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

  • 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.

MEDIA CONTACT:
877-666-8283,
mkaseb@novatekpharmaceuticals.com,
okasseb@novatekpharmaceuticals.com,
aludtke@novatekpharmaceuticals.com

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