The global spread of the pandemic has been stunning. To date, 16.7 million people have been infected around the world. More than 660,000 people have now died. In the U.S. alone, we’ve now seen 4.3 million cases. Brazil is up to 2.4 million cases. India is up to 1.5 million cases. Russia is up to 827,455 cases. South Africa is up to nearly 460,000. Meanwhile, the World Health Organization has warned the situation could get far worse. However, the world may be nearing a vaccine, as many companies enter late-stage trial studies. So far, Moderna and Pfizer have reportedly launched two 30,000-subject trials of vaccines that could lead to regulatory approval and use later this year, according to Reuters. AstraZeneca is another one that said it will begin large scale trials in the U.S. this summer. Some of the top companies to keep an eye on include Revive Therapeutics (CSE:RVV)(OTC:RVVTF), Johnson & Johnson (NYSE:JNJ), Moderna Inc. (NASDAQ:MRNA), Eastman Kodak Company (NYSE:KODK), and Inovio Pharmaceuticals Inc. (NASDAQ:INO).
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 the U.S. Food & Drug Administration has approved the Company to proceed with a randomized, double-blind, placebo-controlled confirmatory Phase 3 clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19.
“The FDA approval of the Phase 3 study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19 is a tremendous milestone for Revive and I am very proud of the dedication of our team and partners to bring forward a potential new treatment option for patients with a confirmed diagnosis of COVID-19 globally,” said Michael Frank, Revive’s Chief Executive Officer. “We thank the FDA for recognizing the importance of this Phase 3 study and we are now focused on executing on our plans for initiating the clinical trial in an expeditious manner.”
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.
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 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.
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.
Other related developments from around the markets include:
Johnson & Johnson (NYSE:JNJ) announced that its lead vaccine candidate protected against infection with SARS-CoV-2, the virus that causes COVID-19, in pre-clinical studies. The data, published in Nature, show the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited a robust immune response as demonstrated by “neutralizing antibodies,” successfully preventing subsequent infection and providing complete or near-complete protection in the lungs from the virus in non-human primates (NHPs) in the pre-clinical study. Based on the strength of the data, a Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, in healthy volunteers, has now commenced in the United States and Belgium. “We are excited to see these pre-clinical data because they show our SARS-CoV-2 vaccine candidate generated a strong antibody response and provided protection with a single dose. The findings give us confidence as we progress our vaccine development and upscale manufacturing in parallel, having initiated a Phase 1/2a trial in July with the intention to move into a Phase 3 trial in September,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.
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.
Eastman Kodak Company (NYSE:KODK) recently received a $765 million loan to support the launch of Kodak Pharmaceuticals from the White House. “With this new agreement, my administration is using the Defense Production Act to provide a $765 million loan to support the launch of Kodak Pharmaceuticals,” said President Trump. “Kodak will now produce generic active pharmaceutical ingredients, which is a big deal. Using advanced manufacturing techniques, Kodak will also make the key starting materials that are the building blocks for many drugs in a manner that is both cost-competitive and environmentally safe. We’ll be competitive with almost all countries, and soon with all countries.”
Inovio Pharmaceuticals Inc. (NASDAQ:INO) a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced that its COVID-19 DNA vaccine INO-4800 targeting SARS-CoV-2 was effective in protecting non-human primates (NHPs; specifically rhesus macaques) from live virus challenge 13 weeks after the last vaccination. These protective results were mediated by memory T and B cell immune responses from INO-4800 vaccination. These results, submitted to a peer-reviewed journal and also published today on the non-peer reviewed online preprint site bioRxiv, demonstrate that INO-4800 reduced viral load in both the lower lungs and nasal passages in macaques that received two doses of INO-4800 (1 mg) four weeks apart and then were challenged with live virus 13 weeks after the second dose (study week 17). The reduced viral loads following exposure to SARS-CoV-2 infection at this timeframe demonstrate an important durable impact mediated by INO-4800. This is the first time a vaccine protection in non-human primates was reported from memory immune responses as previously reported monkey vaccine challenge studies were conducted at the time near their peak immune responses (1-4 weeks from their last vaccination). INO-4800-treated animals demonstrated seroconversion after a single vaccination, with protective neutralizing antibodies and T cells lasting in their blood more than four months after the initial dose. The antibody levels were similar to or greater than those seen in patients who have recovered from COVID-19, the infection caused by SARS-CoV-2, and the T cell responses were significantly higher than those from convalescent patients.
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