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, has added several clinical research sites in Mexico and Brazil to its Phase 3 clinical trial evaluating Avigan®/Reeqonus™ (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19. The expansion into Mexico and Brazil will ensure a timely completion of this pivotal trial and reaffirm favipiravir as one of the most advanced oral COVID-19 antiviral candidates in development with top-line data expected in Q3 2021.
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 Mexico and the first sites are active and enrolling patients. Site activation in Brazil is expected to start in the coming weeks. With the addition of the new sites, Appili expects to complete enrollment and report top-line results by the end of September.
“While the situation is improving in the U.S., COVID-19 remains an international crisis. Here and abroad, physicians and government leaders have been calling for effective oral antiviral medicines to treat these patients. With cases decreasing in the U.S. our clinical expansion into Brazil and Mexico will help us meet our enrollment goal. With this expansion of our trial, we will be able to move quicker towards our goal of determining whether Avigan/Reeqonus is effective in helping people who suffer from mild-to-moderate COVID-19 to recover faster and avoid hospitalization and death,” said Yoav Golan, M.D., Chief Medical Officer, Appili Therapeutics.
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 Sinai Health as part of the early response to the COVID-19 pandemic.
Appili has also planned a Phase 3 study PEPCO (Post Exposure Prophylaxis for COVID-19), designed to evaluate 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 Armand Balboni, Chief Executive Officer, Appili Therapeutics. “However, we also recognize that the value of oral antivirals goes beyond treatment and expect our post-exposure prophylaxis study PEPCO to rapidly follow our PRESECO readout. This Phase 3 study, already filed with the FDA, has the potential to significantly expand the value of Avigan/Reeqonus and protect vulnerable patients.”
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.
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.