[{"orgOrder":0,"company":"Algernon Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Algernon Receives Regulatory and Ethics Approval for Phase 2 Ifenprodil COVID-19 Human Study in South Korea","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Algernon Pharmaceuticals"},{"orgOrder":0,"company":"Revive Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Revive Therapeutics Files Pre-CTA Meeting Request with Health Canada and Update on IND Filing and Phase 3 Clinical Trial Design for Bucillamine in the Treatment of COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Revive Therapeutics"},{"orgOrder":0,"company":"FSD Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FSD Pharma Receives U.S. FDA Approval to Design a Phase 2a Clinical Trial To Treat Patients With Suspected or Confirmed Covid-19 Diagnosis","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"FSD Pharma"},{"orgOrder":0,"company":"Revive Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Revive Therapeutics Announces Submission of IND with U.S. FDA for Phase 3 Confirmatory Study for Bucillamine in COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Revive Therapeutics"},{"orgOrder":0,"company":"FSD Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FSD Pharma Announces Phase 2 Clinical Trial IND Filing With The FDA to Treat Patients With COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"FSD Pharma"},{"orgOrder":0,"company":"Tetra BioPharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Provides Positive Feedback on Tetra Bio-Pharma's Application for ARDS-003 Clinical Development in COVID-19 Patients","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Tetra BioPharma"},{"orgOrder":0,"company":"Resverlogix","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Health Canada Issues Resverlogix Authorization to Begin Immediate Clinical Studies of Apabetalone for Covid-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Resverlogix"}]
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The planned Phase 2 trial will be an open-label study evaluating the safety and efficacy of oral apabetalone, in combination with standard of care for patients hospitalized with COVID-19.
The proposed patient study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ascending doses of ARDS-003 in hospitalized COVID-19 patients with pneumonia and at risk of developing acute respiratory distress syndrome.
The FSD201 COVID-19 Trial will be a multicenter study that assesses the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily, together with standard of care compared to SOC alone in hospitalized patients with COVID-19 disease.
The Phase 3 confirmatory clinical will enroll up to 800 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.
Company has filed its Clinical Trial Application with Health Canada and provides an update on the filing of its IND package to the U.S. FDA for the proposed Phase 3 clinical trial to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19.
The trial will be a randomized, controlled, double-blind, U.S. multicenter study to assess the efficacy and safety of FSD-201 dosed 600mg/1200mg twice-daily plus standard of care versus SOC alone in symptomatic patients with clinical presentation compatible with COVID-19.