21:41:30 EDT Thu 16 May 2024
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Revive Therapeutics Ltd
Symbol RVV
Shares Issued 308,417,884
Close 2023-05-30 C$ 0.055
Market Cap C$ 16,962,984
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Revive begins evaluating bucillamine study data

2023-05-30 09:43 ET - News Release

Mr. Michael Frank reports

REVIVE THERAPEUTICS PROVIDES UPDATE OF PHASE 3 CLINICAL STUDY FOR BUCILLAMINE IN THE TREATMENT OF COVID-19

Revive Therapeutics Ltd. has provided an update on the company's U.S. Food & Drug Administration (FDA) phase 3 clinical trial (NCT04504734) evaluating the safety and efficacy of bucillamine, an oral drug with anti-inflammatory and anti-viral properties, in patients with mild to moderate COVID-19.

Following the independent data safety monitoring board's recommendation that the study be halted, as announced on May 12, 2023, the company has initiated the following activities:

  1. Communicating the study's closure to clinical sites, vendors, institutional review board (IRB) and the FDA;
  2. Evaluating the study's data, including the COVID-19 clinical symptoms data (that is, cough, fever, heart rate and oxygen saturation), time to polymerase chain reaction (PCR) resolution, quantitative PCR-based assessment of SARS CoV-2 viral load, laboratory values (hematology and serum chemistry) and safety assessments;
  3. Planning the study's closeout procedures and final reporting to the FDA and IRB.

The company plans to complete its initial evaluation of the study's data with an independent biostatistician team by the end of June. The company believes that once it has completed the evaluation of the study's data, it could support further discussions with the FDA on potential new clinical studies and allow the opportunity to work with potential domestic and international pharmaceutical partners to determine a suitable regulatory pathway for approval of bucillamine based on the evaluated study's data.

The company is committed to advancing the clinical and commercial development of bucillamine and plans to pursue the following activities:

  1. Continue discussions with the FDA on a pathway for future potential clinical studies for regulatory approval under proposed new efficacy end points based on the evaluation of the study's data;
  2. Work with interested pharmaceutical partners to pursue potential domestic and international regulatory approvals and new clinical studies for long COVID or COVID symptom-related conditions and various infectious, inflammatory and respiratory disorders;
  3. Evaluate drug development strategies for bucillamine, including repurposing and reformulation, to expand on its potential therapeutic utility targeting rare disorders that may come with regulatory incentives awarded by the FDA, such as orphan drug (that is, ischemia-reperfusion injury, cystinuria), fast-track and breakthrough therapy designations.

At this time, the company will only provide regular updates through press releases as information becomes available.

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. There can be no assurance that the company will proceed with the clinical development and regulatory approvals of bucillamine for COVID-19 in the United States and internationally.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as orphan drug, fast-track, breakthrough therapy and rare pediatric disease designations. Currently, the company is exploring the use of bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of psilocybin-based therapeutics in various diseases and disorders. Revive's cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation.

We seek Safe Harbor.

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