Millions of people around the world are in desperate need of a coronavirus treatment. To date, 18.5 million people have been infected, with the death toll up to 701,027. In the U.S., the number of people infected is now up to 4.77million. In Brazil, 2.8 million. In India, 1.9 million. In Russia, 864,948. Unfortunately, until there’s treatment those numbers could escalate even higher, with far more potential deaths. While many companies are racing to produce treatments and vaccines for millions, nothing is available to help just yet. However, some of the companies nearing a potential treatment include Revive Therapeutics (CSE:RVV)(OTC:RVVTF), Gilead Sciences Inc. (NASDAQ:GILD), Moderna Inc. (NASDAQ:MRNA), Johnson & Johnson (NYSE:JNJ), and CytoDyn Inc. (OTC:CYDY).
Revive Therapeutics Ltd. (CSE:RVV)(OTC:RVVTF) BREAKING NEWS: Revive Therapeutics Ltd., a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that following the U.S. Food & Drug Administration approval to proceed with the Company’s Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19, the Company is finalizing agreements and aligning resources to initiate the Phase 3 clinical trial in September.
“With the FDA approval of the Phase 3 clinical study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19, our team and partners are working diligently to align our resources and expertise that will fast-track the Phase 3 study,” said Michael Frank, Revive’s Chief Executive Officer.
Revive expects to engage up to 10 clinical trial sites in the U.S. and open the Phase 3 clinical trial for patient screening in Q3-2020. The Company is finalizing vendor agreements in the project management, medical monitoring, data management and clinical packaging for the trials. In addition, Revive and its clinical trial partners will be evaluating potential U.S. clinical sites and clinical investigators in major COVID-19 affected U.S. states, such as Florida, California, Arizona and Texas.
About the Phase 3 Confirmatory Clinical Study - The Phase 3 confirmatory clinical study titled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19”, will enroll up to 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day (“TID”), Bucillamine 200 mg TID or placebo TID for up to 14 days. The primary objective is to compare frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo. The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of first dose through Day 28 following randomization. Efficacy will be assessed by comparison of clinical outcome (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID‑19 between patients receiving standard-of-care plus Bucillamine (high dose and/or low dose) and patients receiving standard-of-care plus placebo. Safety will be assessed by reported pre-treatment adverse events and treatment-emergent adverse events (including serious adverse events and adverse events of special interest), laboratory values (hematology and serum chemistry), vital signs (heart rate, respiratory rate, and temperature), and peripheral oxygen saturation.
An interim analysis will be performed by an Independent Data and Safety Monitoring Board after 210 patients have been treated and followed up for a total of 28 days after randomization. The better performing Bucillamine dose at the interim analysis will be selected and patients will then be randomized 2:1 to the selected Bucillamine dose or placebo. Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same post-treatment timepoint. The independent DSMB will actively monitor interim data for the ongoing safety of patients and will recommend continuation, stopping or changes to the conduct of the study based on the interim analysis reports.
The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.
Scientific Rationale of Bucillamine for COVID-19 -- Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells. N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV2 infection in the lungs and attenuate the clinical course of COVID-19.
Other related developments from around the markets include:
Gilead Sciences Inc. (NASDAQ:GILD) announced that the company’s Board of Directors has declared a cash dividend of $0.68 per share of common stock for the third quarter of 2020. The dividend is payable on September 29, 2020, to stockholders of record at the close of business on September 15, 2020. Future dividends will be subject to Board approval.
Moderna Inc. (NASDAQ:MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced a preclinical study evaluating mRNA-1273, its vaccine candidate against COVID-19, was published in The New England Journal of Medicine. The study showed a two-dose vaccination schedule of mRNA-1273 led to a robust immune response and protection against SARS-CoV-2 infection in the upper and lower airways in non-human primates, without evidence of vaccine-associated enhanced respiratory disease (VAERD). In the study, immunogenicity and protective efficacy were assessed after a two-dose vaccination schedule of 10 or 100 µg doses of mRNA-1273 or control given four weeks apart (n=24; 8 per group). Four weeks after the second vaccination, animals were challenged with high doses of SARS-CoV-2 through intranasal and intratracheal routes.
Johnson & Johnson’s (NYSE:JNJ) The Janssen Pharmaceutical Companies announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation orbehavior.1SPRAVATO® is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours,1 providing a new option for significant symptom relief until a longer-term, comprehensive treatment plan can take effect. The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®. SPRAVATO® carries a Boxed Warning regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors. See below for Important Safety Information. SPRAVATO® will be made available at REMS certified treatment centers. Janssen is working to responsibly educate and certify treatment centers in accordance with the REMS so healthcare providers can offer SPRAVATO® to appropriate patients.
CytoDyn Inc. (OTC:CYDY), a late-stage biotechnology company, announced an independent Data Safety Monitoring Committee completed its first safety review of the ongoing Phase 3 clinical trial (CD12) in patients with severe and critical COVID-19 and reported it saw no cause to modify the study. The DSMC reviewed compiled safety data from 149 subjects enrolled in the CD12 trial. The DSMC did not raise any concerns regarding safety and recommended that the trial continue. The Phase 3 study currently has 169 enrolled patients and the Company will conduct a full interim analysis once 195 patients are enrolled, as provided in the trial’s protocol. Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We thank the DSMC for its diligence, guidance and support. We are grateful to be less than 30 patients away from our planned interim analysis enrollment goal, and we look forward to sharing those interim efficacy results as soon as possible.”
Legal Disclaimer / Except for the historical information presented herein, matters discussed in this article contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Winning Media is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. Revive Therapeutics has paid three thousand five hundred dollars for advertising and marketing services to be distributed by Winning Media. Winning Media is only compensated for its services in the form of cash-based compensation. Winning Media owns ZERO shares of Revive Therapeutics. Please click here for full disclaimer.
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