The expansion into
Appili's PRESECO (PREventing SEvere COVID-19) study is evaluating the safety and efficacy of Avigan/Reeqonus, an oral antiviral that selectively inhibits viral RNA-dependent RNA polymerase (RdRP), as a potential home-based treatment for patients with mild-to-moderate COVID-19. The primary goal of the study is to demonstrate a significant shortening of the time to sustained recovery for study patients receiving the experimental medicine compared to a placebo.
There are more than 730 U.S. patients currently enrolled in the PRESECO study. Site activation is underway in
'While the situation is improving in the
Recently, an independent Data and Safety Monitoring Board (DSMB) recommended continuation of PRESECO without modification. This expansion is a key component of continuing the trial completion.
As part of the expansion and prioritization of the PRESECO treatment study, Appili has ended its CONTROL trial. CONTROL was a Phase 2 trial designed to determine whether Avigan/Reeqonus could prevent an outbreak of COVID-19 in long-term care settings and originally developed in collaboration with researchers at
Appili has also planned a Phase 3 study
Avigan/Reeqonus for the prevention of COVID-19 when given to asymptomatic individuals who have had direct exposure (within 72 hours) to an infected person. Appili expects to initiate enrollment in the second half of 2021 following successful completion of the PRESECO study.
'We are prioritizing and expanding PRESECO to meet the acute need for effective oral COVID-19 therapies and are looking forward to our top-line data readout next quarter,' said
About the PRESECO Clinical Trial
The Phase 3 PRESECO (Preventing Severe COVID-19 Disease) study is a double-blind, placebo-controlled, randomized, multi-center superiority trial investigating the safety and efficacy of Avigan/Reeqonus in the early treatment outpatient setting for adults infected with COVID-19 and showing mild-to-moderate symptoms. Investigators are enrolling participants at multiple clinical trial sites in
About Avigan/Reeqonus
Avigan/Reeqonus is a broad-spectrum antiviral in oral tablet form. It is a selective inhibitor of viral RNA-dependent RNA polymerase (RdRP) with potent antiviral activity against single-stranded RNA viruses, including coronaviruses. Developed by
Appili has joined a consortium of companies, including
About
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 location of the proposed Avigan /Reeqonus (generic name: favipiravir) clinical trials and the likelihood that such clinical trials will be consummated on the terms and timeline provided herein or at all; the anticipated timing for completion of the study and the release of study data; the potential use of 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 of the parties with respect to 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: timing of clinical results; 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 the continuation and/or expansion of the clinical trials, the timely completion of such trials and their 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 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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