Appili Therapeutics Announces Last Patient Enrolled in Phase 3 Trial of Oral Avigan®/Reeqonus™ for the Treatment of Mild-to-Moderate COVID-19
More than 1,200 patients enrolled in
Study expected to include patients with top priority COVID-19 variants, including Delta
Appili launched the PRESECO clinical trial in
“Completing enrollment in this large Phase 3 pivotal trial in just ten months is a tremendous accomplishment for Appili. With this major milestone now achieved, we have a clear path to completing the PRESECO data analysis in the coming weeks and determining if Avigan/Reeqonus has the potential to meet the urgent global clinical need for a safe and effective oral treatment for this deadly disease,” said
The primary goal of PRESECO is to evaluate the impact of oral Avigan/Reeqonus on time to COVID-19 symptom resolution. The study also aims to evaluate the effect of oral treatment on progression to more severe COVID-19 disease. Finally, this Phase 3 clinical trial includes a viral shedding sub-study, which is evaluating impact of the treatment on time to viral clearance. Viral isolates will also be sequenced for identification of COVID-19 variants.
“As we have seen over the past 18 months, this virus continues to mutate, enhancing its ability to infect and cause significant symptoms, especially in those who have not been vaccinated. My hope is that Avigan/Reeqonus will emerge as a standard of care treatment for mild to moderate COVID-19 patients, resolve patient’s symptoms more rapidly, and limit progression to more severe disease,” 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, global superiority trial investigating the safety and efficacy of oral Avigan/Reeqonus in the early treatment for adults infected with COVID-19 and showing mild-to-moderate symptoms. Participants were enrolled at multiple clinical trial sites in
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 Dr. Reddy’s Laboratories, Global Response Aid, and FFTC, for the worldwide development and distribution of Avigan/Reeqonus tablets for the potential treatment and prevention of COVID-19 (excluding
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 ongoing Avigan® /Reeqonus (generic name: favipiravir) clinical trial and the likelihood that such clinical trial will be consummated on the terms and timeline provided herein or at all; the anticipated timing for completion of each 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 clinical trial;; other expectations and assumptions concerning the clinical trial (including with respect to 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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