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Appili Therapeutics announced that its Phase 3 PRESECO clinical trial of Avigan®/Reeqonus™ (favipiravir) for mild-to-moderate COVID-19 patients failed to meet the primary endpoint of sustained clinical recovery. The trial enrolled 1,231 patients across 38 sites in the United States, Mexico, and Brazil. Despite this disappointment, Appili remains committed to developing effective treatments for COVID-19 and other infectious diseases. Ongoing analyses of trial data may enhance future research efforts.
Positive
Ongoing analyses of trial data may provide insights for future research.
The company remains committed to addressing infectious diseases.
Negative
The PRESECO trial did not achieve statistical significance on the primary endpoint.
HALIFAX, Nova Scotia--(BUSINESS WIRE)--
Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced that the Phase 3 PRESECO (PREventing SEvere COVID-19) clinical trial evaluating oral antiviral Avigan®/Reeqonus™(favipiravir) for the treatment of mild-to-moderate COVID-19 did not achieve statistical significance on the primary endpoint of time to sustained clinical recovery. Additional analyses of the trial data are ongoing. The clinical trial enrolled 1,231 patients with mild-to-moderate COVID-19 from 38 study sites across the United States, Mexico, and Brazil.
“While we are disappointed by the topline results of the PRESECO trial, we remain steadfast in our belief that safe and effective oral antivirals are urgently needed for patients who are still struggling to overcome COVID-19. We wish to thank all the patients who participated, and hope that information obtained from our trial can help guide research and development around more potential treatment options for COVID-19,” said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. “Appili remains committed to addressing the challenges posed by infectious diseases and we will continue developing our pipeline to improve patient lives around the world.”
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 the United States, Brazil and Mexico. Participants were outpatients with mild-to-moderate symptoms who have had a recent positive COVID-19 test (within 72 hours of enrollment). Participants self-administered the drug regimen in their homes, with clinical investigators monitoring patients remotely.
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 FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza. Unlike most other interventions that researchers are evaluating in COVID-19, Avigan/Reeqonus has already been thoroughly studied in human trials and has a well-known safety profile, with over 3,000 subjects receiving at least one dose of the drug. Avigan/Reeqonus’ oral tablet form is shelf-stable and has an established commercial manufacturing process, which may provide advantages over other COVID-19 interventions, which often require temperature-controlled storage and/or injection or intravenous administration.
About Appili Therapeutics
Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. As part of a global consortium, Appili is sponsoring late-stage clinical trials evaluating the antiviral Avigan/Reeqonus for the worldwide treatment and prevention of COVID-19. The Company is also advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.
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. 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 involve significant known and unknown risks, uncertainties and assumptions, including those listed in the annual information form of the Company dated June 23, 2021 and the other filings made by the Company with the Canadian securities’ regulatory authorities (which may be viewed under the Company’s profile on SEDAR at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.
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.
What were the results of the Phase 3 PRESECO trial for APLIF?
The Phase 3 PRESECO trial did not achieve statistical significance on the primary endpoint of sustained clinical recovery for Avigan/Reeqonus in COVID-19 patients.
How many patients were enrolled in the PRESECO trial?
The PRESECO clinical trial enrolled 1,231 patients with mild-to-moderate COVID-19.
What is Avigan/Reeqonus used for?
Avigan/Reeqonus is an oral antiviral under investigation for the treatment of mild-to-moderate COVID-19.
What are the next steps for Appili Therapeutics after the PRESECO trial results?
Appili Therapeutics will continue to analyze the trial data and seek to develop new treatment options for COVID-19 and other infectious diseases.
Where was the PRESECO trial conducted?
The PRESECO trial was conducted across 38 study sites in the United States, Mexico, and Brazil.
