Revive Therapeutics Provides Update From FDA Meeting for Long COVID Diagnostic Product

Rhea-AI Summary

On June 10, 2024, Revive Therapeutics announced an update from the FDA regarding their Long COVID Diagnostic Product, the Revive LC POC Lateral Flow Test Kit. The FDA recommended the product follow the De Novo regulatory pathway, necessitating a clinical study for possible approval. CEO Michael Frank confirmed alignment with the FDA's recommendations and plans to discuss development and timelines with potential contract manufacturers. The product, developed under Revive Diagnostics, aims to detect long COVID via blood biomarkers identified by Dr. Douglas Fraser's research, recently published in Molecular Medicine. Currently, no FDA-approved diagnostic exists for long COVID, which affects at least 10% of SARS-CoV-2 infections and involves over 200 symptoms impacting multiple organ systems.

Positive

• FDA provides clear regulatory pathway (De Novo) for Revive LC POC Lateral Flow Test Kit.
• Revive plans to discuss development and timelines with potential contract manufacturers.
• Product aims to fill a significant diagnostic gap for long COVID, affecting at least 10% of SARS-CoV-2 infections.
• Blood biomarkers identified by reputable research team and published in Molecular Medicine.

Negative

• Clinical study required for De Novo submission could delay product approval.
• Currently no FDA-approved diagnostic for long COVID, indicating high competition and uncertainty.
• Potential high costs associated with conducting required clinical studies.
• Over 200 symptoms identified in long COVID make it a complex condition to diagnose accurately.

TORONTO, June 10, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics and diagnostics for infectious diseases, medical countermeasures, and rare disorders, announced today an update on the meeting written responses received by the Company from the U.S. Food & Drug Administration (“FDA”) of the Revive LC POC Lateral Flow Test Kit (the “Product”) for feedback on the classification, development and regulatory submission strategy for a point-of-care in vitro diagnostic device that aids in the detection of post COVID-19 conditions. The FDA has determined that the Product should follow the De Novo regulatory pathway, and the Company would be required to conduct a clinical study for the De Novo submission for possible approval.

“We agree with the FDA feedback and with their recommendations that provides a pathway for the development of the Revive LC POC Lateral Flow Test Kit in the detection of long COVID,” said Michael Frank, CEO of Revive. “We will now discuss the proposed development plan and timelines with potential contract manufacturers.”

The Company, under its wholly-owned subsidiary Revive Diagnostics Inc., is advancing the Product as a potential blood biomarker diagnostic that characterizes long COVID. The discovery of the biomarkers identified by a research team at Lawson, led by Dr. Douglas Fraser, was recently published in the journal, Molecular Medicine¹.

Currently, there is no FDA-approved clinical diagnosis of long COVID and it is estimated to occur in at least 10% of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. More than 200 symptoms have been identified with impacts on multiple organ systems² — including fatigue, brain fog, difficulty breathing, and cardiovascular symptoms ranging from chest pain and arrhythmias to sudden cardiac death—but it remains a diagnosis of exclusion with an unknown biological basis³.

The Company entered into a license agreement with Lawson Health Research Institute for the worldwide exclusive rights to the intellectual property of novel blood biomarkers that characterize long COVID. The intellectual property includes PCT/CA2023/050145 entitled “Blood Biomarkers in Long-COVID19”; PCT/CA2023/051292 entitled “Biomarkers in Long-COVID19”; and US Provisional Patent Application No. 63/433,425 entitled “Diagnosis and Treatment of Long-COVID”.

About Revive Therapeutics Ltd.

Revive Therapeutics is a life sciences company focused on the research and development of therapeutics and diagnostics for infectious diseases, medical countermeasures, and rare disorders. Revive prioritizes its drug development efforts to take advantage of several regulatory incentives awarded by the FDA, such as Emergency Use Authorization, Orphan Drug, Fast Track, and Breakthrough Therapy designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of nerve agent exposure and long COVID. Revive is also advancing the development of Psilocybin-based therapeutics through various programs. For more information, visit www.ReviveThera.com.

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “may”, “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company's management's discussion and analysis for the three and nine months ended March 31, 2024 ("MD&A"), dated May 28, 2024, which is available on the Company's profile at www.sedarplus.ca.

 Source:

1. “Elevated vascular transformation blood biomarkers in Long-COVID indicate angiogenesis as a key pathophysiological mechanism.” Molecular Medicine 28, 122 (2022). London researchers discover novel method to diagnose long COVID | Lawson Health Research Institute (lawsonresearch.ca)
   
   
2. Davis, H.E., McCorkell, L., Vogel, J.M. et al. Long COVID: major findings, mechanisms and recommendations. Nat Rev Microbiol 21, 133–146 (2023). https://doi.org/10.1038/s41579-022-00846-2; access https://www.nature.com/articles/s41579-022-00846-2
   
   
3. “Proteins In The Blood Hint At Biological Basis Of Long COVID”, Clinical Research News, August 11, 2023, https://www.clinicalresearchnewsonline.com/news/2023/08/11/proteins-in-the-blood-hint-at-biological-basis-of-long-covid
   

FAQ

What is the FDA's recommendation for Revive Therapeutics' Long COVID Diagnostic Product (RVVTF)?

The FDA recommended that the Revive LC POC Lateral Flow Test Kit follow the De Novo regulatory pathway, requiring a clinical study for possible approval.

What does the De Novo regulatory pathway mean for RVVTF?

The De Novo regulatory pathway is a process for the FDA to classify novel medical devices, which requires Revive Therapeutics to conduct a clinical study to seek approval for their diagnostic product.

Why is a clinical study necessary for the Revive LC POC Lateral Flow Test Kit?

A clinical study is necessary to gather data on the effectiveness and safety of the diagnostic product as part of the FDA's De Novo submission requirements.

What are the potential benefits of the Revive LC POC Lateral Flow Test Kit for long COVID?

The product aims to provide a point-of-care diagnostic tool to detect long COVID through blood biomarkers, addressing a significant unmet medical need.

What is the current status of FDA-approved diagnostics for long COVID?

As of now, there is no FDA-approved clinical diagnostic for long COVID.

What symptoms does long COVID include?

Long COVID includes over 200 symptoms such as fatigue, brain fog, difficulty breathing, and cardiovascular issues like chest pain and arrhythmias.

Who conducted the research on blood biomarkers for long COVID?

The research on blood biomarkers was led by Dr. Douglas Fraser and published in the journal Molecular Medicine.