Canada

Revive Therapeutics

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CANADA Canada

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Chinaplas 2020

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Revive Therapeutics Announces Submission of IND with U.S. FDA for Phase 3 Confirmatory Study for Bucillamine in COVID-19

Lead Product(s): Bucillamine

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 30, 2020

Details:

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.

Revive Therapeutics

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CANADA Canada

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Chinaplas 2020

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Revive Therapeutics Files Pre-CTA Meeting Request with Health Canada and Update on IND Filing and Phase 3 Clinical Trial Design for Bucillam...

Lead Product(s): Bucillamine

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 03, 2020

Details:

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.

FSD Pharma

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Chinaplas 2020

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FSD Pharma Receives U.S. FDA Approval to Design a Phase 2a Clinical Trial To Treat Patients With Suspected or Confirmed Covid-19 Diagnosis

Lead Product(s): Palmitoylethanolamide

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 03, 2020

Details:

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.

Algernon Pharmaceuticals

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CANADA Canada

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Chinaplas 2020

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Algernon Receives Regulatory and Ethics Approval for Phase 2 Ifenprodil COVID-19 Human Study in South Korea

Lead Product(s): Ifenprodil Tartrate

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 23, 2020

Details:

The 40-patient, 4-week trial, is designed to test the effect of Ifenprodil in COVID-19 infected patients with severe pneumonia.

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Revive Therapeutics

Revive Therapeutics Announces Submission of IND with U.S. FDA for Phase 3 Confirmatory Study for Bucillamine in COVID-19

Revive Therapeutics

Revive Therapeutics Files Pre-CTA Meeting Request with Health Canada and Update on IND Filing and Phase 3 Clinical Trial Design for Bucillam...

FSD Pharma

FSD Pharma Receives U.S. FDA Approval to Design a Phase 2a Clinical Trial To Treat Patients With Suspected or Confirmed Covid-19 Diagnosis

Algernon Pharmaceuticals

Algernon Receives Regulatory and Ethics Approval for Phase 2 Ifenprodil COVID-19 Human Study in South Korea