At the moment, the CV-19 pandemic shows no signs of slowing. To date, there are nearly 33.4 million cases, with 1.002 million deaths. In the U.S., cases are up to 7.15 million. Brazil is up to 4.7 million. India is nearing 6.2 million. Russia is now up to 1.16 million. Meanwhile, the World Health Organization has warned the situation could get far worse, meaning we need treatment immediately. With the coronavirus still around us, some of the top companies racing to develop treatments, include Revive Therapeutics Ltd. (CSE:RVV)(OTC:RVVTF), Moderna Inc. (NASDAQ:MRNA), Gilead Sciences Inc. (NASDAQ:GILD), Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), and Pfizer Inc. (NYSE:PFE).
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 an update on the Company’s U.S. Food & Drug Administration Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19. The Company has selected and finalized with five clinical sites in Florida, Texas and California for enrollment of patients in the Phase 3 clinical study, and is finalizing agreements with an additional ten clinical sites in these states including Arizona and Ohio where patient enrollment should start in October within these other locations.
“We have made significant progress in advancing the Phase 3 clinical trial since the FDA approval allowed us to proceed with the study, and we are expanding on and engaging with clinical sites in high prevalence COVID-19 infected states, which will enable us to meet our enrollment goals and expedite the potential FDA approval and commercialization of Bucillamine for the treatment of COVID-19,” said Michael Frank, Revive’s Chief Executive Officer.
About the Phase 3 Clinical Trial
The Phase 3 confirmatory clinical trial 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 the 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 the first dose through Day 28 following randomization. Efficacy will be assessed by comparing clinical outcomes (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 (“DSMB”) after 210 patients have been treated and followed up for 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 Dr. Stephen Hoge, President, will participate in the Chardan Virtual 4th Annual Genetic Medicines Conference on October 5, 2020 at 2:00 p.m. ET. A live webcast will be available under “Events and Presentations” in the Investors section of the Moderna website. A replay of the webcast will be archived on Moderna’s website for 30 days following the presentation.
Gilead Sciences Inc. (NASDAQ:GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) announced that the European Commission (EC) has granted marketing authorization for Jyseleca® (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately to, or are intolerant to, one or more disease modifying anti-rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX).
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi announced the presentation of positive pivotal trial data for the investigational use of PD-1 inhibitor Libtayo® (cemiplimab) in first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. The trial compared Libtayo monotherapy to platinum-doublet chemotherapy in patients whose tumor cells expressed PD-L1, including those whose cancers had confirmed PD-L1 expression of ≥50%. These results form the basis of regulatory submissions, including in the U.S. and European Union. "In new analyses presented at ESMO, Libtayo reduced the risk of death by 43% in patients whose cancer had confirmed PD-L1 expression of 50% or greater. This is notable given that nearly three-quarters of patients crossed over from chemotherapy following disease progression and 12% of patients had pretreated and stable brain metastases," said Ahmet Sezer, M.D., Associate Professor in the Department of Medical Oncology at Baskent University in Adana, Turkey and a trial investigator. "These results support Libtayo as a potential new option for anti-PD-1 monotherapy in first-line advanced non-small cell lung cancer.”
Pfizer Inc. (NYSE:PFE) announced that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Two formulations were approved, a tablet and an oral solution, and are dosed based upon weight.1 This approval makes XELJANZ the first and only Janus kinase (JAK) inhibitor approved in the U.S. for the treatment of pcJIA. “Polyarticular course juvenile idiopathic arthritis, or pcJIA, is debilitating as it can cause significant jointpain and limit participation in child appropriate activities,” said Dr. Hermine Brunner, Director of the Division of Rheumatology at Cincinnati Children’s Hospital Medical Center and Scientific Director of the Pediatric Rheumatology Collaborative Study Group. “Although there arealready several advanced treatments available, tofacitinib will be an appealing new option given it does not require injectionsor infusions. These can be quite burdensome to both children with pcJIA and their caretakers. The FDA approval of Xeljanz for pcJIA is positive news for this community as it provides a new advanced treatment option in an oral formulation.
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. Winning Media is only compensated for its services in the form of cash-based compensation. Pursuant to an agreement Winning Media has been paid three thousand five hundred dollars for advertising and marketing services for Revive Therapeutics Ltd. by a third party. We own ZERO shares of Revive Therapeutics Ltd. Please click here for full disclaimer.
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