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Revive Therapeutics holds pre-CTA meeting with Health Canada for Bucillamine to treat COVID-19 patients

Revive said the agency provided valuable guidance on the proposed clinical study design and information required for the submission of a complete CTA package

Revive Therapeutics - Revive Therapeutics Ltd holds Pre-Clinical Trial Application meeting with Health Canada to evaluate the potential of a clinical study of Bucillamine to treat patients with mild-to-moderate COVID-19
The company is aiming to file its Investigational New Drug package to the US Food and Drug Administration for the proposed Phase 3 confirmatory clinical trial this month.

Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF), announced Tuesday that it held a Pre-Clinical Trial Application meeting with Health Canada to evaluate the potential of a clinical study of Bucillamine to treat patients with mild-to-moderate COVID-19.

The Toronto-based specialty life sciences company said the meeting provided an opportunity for Revive to discuss Bucillamine’s scientific rationale of its potential use in the treatment of COVID-19 infections. In addition, the meeting included a briefing package detailing Bucillamine’s chemistry, manufacturing and controls, non-clinical and clinical safety information, and clinical trial design. 

Revive said Health Canada provided valuable guidance on the proposed clinical study design and information required for the submission of a complete Clinical Trial Application (CTA) package.  

READ: Revive Therapeutics to submit IND for Bucillamine

The company is aiming to file its Investigational New Drug (IND) package to the US Food and Drug Administration for the proposed Phase 3 confirmatory clinical trial this month.

Revive said it now intends to follow up with the submission of the complete CTA package for Health Canada around this Phase 3 study as part of the same multinational clinical strategy.

“We were pleased with our discussions with Health Canada at the pre-CTA meeting which provided us with valuable guidance on the clinical study design and information that is required for the submission of the complete CTA package,” said CEO Michael Frank in statement.

“We are focused on advancing Bucillamine as a potential treatment for COVID-19, and the submission of our FDA IND application for our Phase 3 clinical study will form the foundation for our multinational clinical plans including Canada.”

However, the company cautioned that it is not making any express or implied claims that its product has the ability to eliminate or cure the COVID-19 disease and the SARS-CoV-2 virus that causes it. Bucillamine was first designed as a rheumatoid arthritis treatment.

Revive is focused on research and development of drugs for infectious diseases and rare disorders. With its recent acquisition of Psilocin Pharma, Revive is also advancing the development of psilocybin-based therapeutics.

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

 

 

 

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Price: 0.225 CAD

CSE:RVV
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