The world is in desperate need for a pandemic treatment -- anything to halt the spread. Thousands of people are being infected by the day. Thousands have died. Medical experts have urged President Trump, Congress, and states to shut down again. Schools around the country have opted for another few months of virtual learning. After all, the virus is still here – and it’s only getting worse. The U.S., China, India, Russia, and Korea are seeing higher numbers. Worse, we’re “on the cusp of losing control” of the situation, says former US FDA Commissioner, Dr. Scott Gottlieb. Even the World Health Organization just said the “pandemic is still accelerating.” The good news is we may be nearing a possible treatment. In fact, some of the top companies to watch for potential include Revive Therapeutics (CSE:RVV)(OTC:RVVTF), Moderna Inc. (NASDAQ:MRNA), Gilead Sciences Inc. (NASDAQ:GILD), Regeneron Inc. (NASDAQ:REGN), and Vaxart Inc. (NASDAQ:VXRT).
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 proceeding with plans to expand the Phase 3 clinical trials in Asia-Pacific Countries and Canada.
“With the approval from the FDA to conduct the Phase 3 clinical trial in COVID-19 and our progress that we have made to date, we are now establishing plans to complement and support our initiatives in the U.S. to include clinical sites in APAC and Canada,” said Michael Frank, Revive’s Chief Executive Officer.
Revive expects to open the Phase 3 clinical trial for patient enrollment and dosing in September 2020. Further to the Company signing a Memorandum of Understanding with Attwill Medical Solutions Sterilflow, LP to establish AMS as a resource for clinical packaging and distribution for the Phase 3 clinical trial, the Company continues to finalize vendor agreements in project management, medical monitoring, and data management. In addition, Revive and its clinical trial partners are evaluating potential clinical sites and clinical investigators in the U.S., APAC and Canada to complement some of the sites previously mentioned in California, Florida, 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, 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.1 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 glutathione2,3,4,5. 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 6. 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:
Moderna Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that the U.S. government has secured 100 million doses of mRNA-1273 as part of the U.S. government’s goal of securing early access to safe and effective COVID-19 vaccines for the American people. Today’s award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of mRNA-1273 including incentive payments for timely delivery of the product. With the previous award of up to $955 million from BARDA for the development of mRNA-1273 to licensure, today’s announcement brings the U.S. government commitments for early access to mRNA-1273 to up to $2.48 billion. Under the terms of the agreement, the U.S.government, as a part of Operation Warp Speed, will also have the option to purchase up to an additional 400 million doses of mRNA-1273 from Moderna. The U.S. government has announced that consistent with its commitment to free access to COVID-19 vaccines, Americans will receive mRNA-1273 at no cost for the vaccine itself. As is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine.
Gilead Sciences Inc. (NASDAQ:GILD) and Tango Therapeutics announced an expanded strategic collaboration focused on the discovery, development and commercialization of innovative targeted immune evasion therapies for patients with cancer. Under the expanded multi-year collaboration, which builds on an agreement signed in 2018, Tango will continue to leverage its proprietary, CRISPR-enabled functional genomics target discovery platform to identify novel immune evasion targets. The number of targets covered will expand from five to 15. Gilead will have options to worldwide rights for programs directed at these targets over the next seven years. Gilead will also have the right to pay option extension fees for Tango to lead activities through early clinical development, to which Gilead will retain its option rights. Tango will have the option to co-develop and co-promote the lead products for up to five programs in the United States.
Regeneron Inc. (NASDAQ:REGN) announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a Biologics License Application (BLA) for evinacumab as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH). Evinacumab is the first investigational medicine of its kind to show efficacy in patients with HoFH – including patients with little to no low-density lipoprotein (LDL) receptor function – by binding to and blocking the function of angiopoietin-like 3 (ANGPTL3). The target action date for the FDA decision is February 11, 2021. The FDA granted evinacumab Breakthrough Therapy designation in 2017 for the treatment of hypercholesterolemia in patients with HoFH.
Vaxart Inc. (NASDAQ:VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, announced that its COVID-19 Investigational New Drug (IND) application has been filed with the US Food and Drug Administration (FDA). “We are very excited to reach this important milestone in advancing our oral COVID-19 vaccine candidate towards the clinic,” said Andrei Floroiu, chief executive officer of Vaxart. “We expect our upcoming Phase I study to generate data that will further differentiate our oral vaccine from injectable vaccines by substantiating the importance of activating both systemic and mucosal immunity in protecting against COVID-19. We believe that this mechanistic benefit combined with the significant advantages of oral administration to the patient while eliminating the need for cold chain distribution, could make our COVID-19 vaccine an ideal candidate for successful mass vaccination campaigns globally.”
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