'Addressing infections and spread early in the community setting remains a particular unmet need for COVID-19, and that is the cornerstone of our clinical strategy,' said Dr.
The primary objective of the PEPCO study is to determine if the use of Avigan is safe and effective in preventing COVID 19 among vulnerable individuals who have had recent direct exposure to a confirmed COVID-19-infected person. Appili has contracted with
This is the second Phase 3 study Appili has announced to evaluate the utility of Avigan tablets against COVID-19 in the community setting. The other study also known as the PRESECO study, is evaluating Avigan for the treatment of adults with mild-to-moderate symptoms of COVID-19. PRESECO's objective is to determine if Avigan is safe and effective in shortening the time to clinical recovery, preventing progression to severe disease, and diminishing the period of infectiousness. In addition to the PEPCO and PRESECO studies, Appili is sponsoring a Phase 2 CONTROL study evaluating the use of Avigan to control outbreaks of COVID-19 in Canadian long-term care facilities, where the burden of severe disease and death is unusually high.
'Our clinical strategy focuses on determining when, and who, may benefit most from using Avigan to treat and prevent outbreaks of COVID-19. The PEPCO study aims at providing early intervention to those most vulnerable to severe infections, with the aim of controlling outbreaks in homes and outpatient facilities,' said Dr.
About the PEPCO Study
PEPCO is a double-blinded, placebo-controlled, randomized, multinational, Phase 3 clinical trial that will enroll approximately 1,156 participants through 47 medical centers ('sites'). Site investigators will oversee participant enrollment, intervention, and follow-up during the course of the study. Participants will be outpatients residing in assisted living facilities or their own private residences.
Researchers will be evaluating the safety and efficacy of Avigan in preventing the development of COVID-19 when given to asymptomatic individuals who had direct exposure (within 72 hours) to an infected person. Inclusion criteria focuses on vulnerable individuals who are at high risk of developing severe complications of COVID-19, including: individuals 60 years of age or older regardless of having underlying comorbidities, or individuals who are 18 years of age or older who have at least one significant underlying condition.
The PEPCO (preventative) and PRESECO (treatment) trials are designed to give researchers the option to accelerate enrollment by coordinating with infected individuals and those they may have exposed, wherein those who test positive for COVID-19 are enrolled into the PRESECO trial, and consenting associates with whom they've been in contact may be enrolled in the PEPCO study. The PEPCO and PRESECO studies will be part of the dataset for the recently announced consortium to develop and distribute Avigan tablets globally in COVID-19 indications. As part of that agreement, Appili is focused initially on clinical development in
About Avigan (Favipiravir)
Avigan is a broad-spectrum antiviral in oral tablet form developed by
Unlike most other interventions that researchers are evaluating in COVID-19, Avigan has already been thoroughly studied in human trials and has a known safety profile, with over 3,000 subjects receiving at least one dose of the drug. There is also an established manufacturing process in place that can be used to ramp up supply, should the drug receive regulatory approvals in additional indications. Avigan's oral tablet form is shelf-stable and may provide advantages in the community setting over other COVID-19 interventions, which often require temperature-controlled storage and/or injection or intravenous administration.
Appili has joined a consortium of companies, including
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Forward looking statements
This news release contains 'forward-looking statements,' which reflect the current expectations of the Company's management for future growth, results of operations, performance and business prospects and opportunities, including statements with respect to: the design, scope, parameters and timeline of the proposed Avigan (favipiravir) clinical trials and the likelihood that such clinical trials will be initiated or consummated on the terms and timeline provided herein or at all; the potential use of Avigan (favipiravir) for the treatment of COVID-19 (including as an early treatment of COVID-19 to control disease progression and limit virus spread) and the development, manufacturing and commercialization plans with respect to Avigan (favipiravir). Wherever possible, words such as 'may,' 'would,' 'could, ' 'should,' 'will,' 'anticipate,' 'believe,' 'plan,' 'expect,' 'intend,' 'estimate,' 'potential for' and similar expressions have been used to identify these forward-looking statements. Forward looking statements contained in this press release are provided in reliance on certain assumptions, including with respect to: securing all requisite required approvals and funding for the applicable clinical trials; finalizing mutually acceptable clinical trial agreement and related agreements with the applicable clinical research organizations relating to the applicable clinical trials; site and patient enrolment; other expectations and assumptions concerning the proposed clinical trials (including with respect to potential outcomes and benefits) and the ability of the parties to successfully develop, manufacture and commercialize favipiravir for the treatment of COVID-19 following successful completion of the requisite clinical trials and receipt of all requisite regulatory and other approvals. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company cannot give assurance that these expectations will prove to have been correct.
Forward-looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, economic, competitive, political and social uncertainties; known and unknown risks and liabilities relating to the ongoing COVID-19 pandemic; risks relating to the inability of Appili to initiate or complete all requisite clinical trials (including risks relating to the outcome thereof) and to secure all required funding and approvals relating thereto; risks relating to the development, manufacturing and commercialization of Avigan (favipiravir) in
The Company is not making any express or implied claims that it has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 coronavirus) at this time.
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