Independent Data Safety Monitoring Board Recommends Appili Therapeutics Complete Its Phase 3 Avigan®/Reeqonus™ Trial for M...

HALIFAX, NS, May 17, 2021 /PRNewswire/ -- Appili Therapeutics Inc. (TSX: APLI, OTCQX: APLIF) (the "Company" or "Appili"), a biopharmaceutical company focused on drug development for infectious diseases, today announced that an independent Data and Safety Monitoring Board (DSMB) has recommended continuation without modification of Appili's ongoing Phase 3 PRESECO (PREventing SEvere COVID-19) trial evaluating Avigan®/Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19. 

"Even with effective vaccines available, COVID-19 is here to stay for the foreseeable future. A safe and effective oral anti-viral medicine is what government leaders and physicians around the world have been asking for since the start of the pandemic. We remain hopeful that once PRESECO is completed, Avigan/Reeqonus will emerge as the first prescription oral medicine for newly diagnosed patients with COVID-19," said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. 

The PRESECO 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 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. The DSMB reported no safety issues that would have required the study to be terminated. It also did not recommend stopping the study for futility. As a result, Appili will continue the study without modification.  

The interim analysis is based on data from approximately 600 subjects. Appili Therapeutics will continue recruiting patients at the 27 study sites across the United States and expects to report top-line results in Q3 2021, which will inform subsequent interactions with regulators, including the possibility Appili will pursue an Emergency Use Authorization from the U.S. Food and Drug Administration.

"COVID-19 is surging again in various parts of the world, including Asia and South America. As a practicing infectious diseases physician, I understand the importance of discovering and delivering new medicines to treat COVID-19 here and around the world," said Yoav Golan, Chief Medical Officer, Appili.

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 the United States. Participants are expected to be outpatients who do not require hospitalization and who have had a recent positive COVID-19 test (within 72 hours of enrollment). Participants self-administer the drug regimen in their homes, with clinical investigators monitoring them 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.

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 Japan, China, and Russia.) This consortium is designed to ensure that Avigan/Reeqonus is thoroughly evaluated in rigorous clinical studies and, if it receives the proper regulatory approvals, has the infrastructure in place to support worldwide manufacturing and distribution.

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, 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 Canada, the U.S and other jurisdictions; unforeseen events, developments, or factors causing any of the aforesaid expectations and assumptions not to be correct; and the other risk factors listed in the annual information form of the Company dated June 24, 2020 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.

Media Contacts
Mackenzie Mittleman/APCO Worldwide
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Investor Relations Contacts
Kimberly Stephens, CFO
Appili Therapeutics
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Laura Kiernan, IRC, CPA
High Touch Investor Relations
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