Appili Therapeutics Provides Enrollment Update for Its Phase 3 PRESECO Trial Evaluating the Oral Antiviral Favipiravir as an Early Treatment in COVID-19
12 sites in the United States are actively recruiting for the double-blind placebo-controlled study in mild-to-moderate patients with COVID-19
The Company is prioritizing resources on the pivotal study and expects to provide interim data readout by late March 2021
HALIFAX, Nova Scotia, January 28, 2021 – Appili Therapeutics Inc. (TSX: APLI, OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced that its Phase 3 PRESECO (PReventing SEvere COvid-19) clinical trial is actively recruiting participants in 12 out of 20 sites in the United States. Based on current forecasts, Appili believes that it will reach the enrollment threshold required to provide an interim data readout by late March 2021. PRESECO is evaluating favipiravir, an oral antiviral, in the early treatment of COVID-19 in the outpatient setting. In addition, the Company is pursuing regulatory approvals to expand PRESECO into sites in Mexico, Brazil, and Colombia.
“Similar to the way our public health system uses both antivirals and vaccines to stem the impact of influenza, we believe that there is a critical place in the coronavirus treatment arsenal for antivirals — like favipiravir — that can be orally administered in homes and community settings shortly after onset of an infection,” said Dr. Armand Balboni, CEO, Appili Therapeutics. “Our PRESECO study is designed to answer the critical question, ‘does favipiravir work for COVID-19 patients early in the outpatient setting?’”
Appili plans to prioritize its resources to accelerate recruitment and data analysis for the PRESECO study. The Company expects to continue its CONTROL and PEPCO trials as label expansion studies to obtain data on the use of favipiravir in post-exposure prophylaxis indications.
Appili is working with a consortium of companies, including Dr Reddys Laboratories (DRL) and Global Response Aid (GRA), to evaluate favipiravir for potential worldwide use in COVID-19. GRA and DRL recently announced data from a study in Kuwait. While that study did not reach statistical significance in its primary endpoint in moderate-to-severe hospitalized patients, a sub-group analysis of the mild-to-moderate patients demonstrated a statistically and clinically significant three-day earlier discharge from the hospital in those treated with favipiravir compared to placebo.
“The sub-group analyses from the Kuwait study, along with other published data on the use of favipiravir, support Appili’s hypothesis that the earlier in the treatment timeline patients receive antivirals, the more likely they are to benefit from the treatment,” continued Dr. Balboni. “We believe the quickest path to registration is to evaluate that hypothesis directly in a robust, double-blind, placebo-controlled study, which is exactly what PRESECO is designed to accomplish. By prioritizing our resources and accelerating our recruitment and data collection efforts, we expect to be able to share an interim read-out in March.”
About Appili’s Phase 3 PRESECO Clinical Trial
The Phase 3 PRESECO (Preventing Severe COVID-19 Disease) study is a double blinded, placebo-controlled multi-center trial investigating the safety and efficacy of favipiravir in the early treatment outpatient setting for adults infected with COVID-19 and showing mild to moderate symptoms. Appili plans to recruit approximately 826 eligible participants, who are recently diagnosed as COVID-19 positive with mild to moderate symptoms. Investigators are enrolling patients at multiple clinical trial sites in the U.S., with planned expansions into Mexico, Brazil and Colombia. Participants are expected to be outpatients who do not require hospitalization and who have had a recent positive COVID-19 test. Participants will self-administer the drug regimen in their homes, with clinical investigators monitoring them remotely.
Favipiravir is a broad-spectrum antiviral in oral tablet form 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, favipiravir 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. Favipiravir’s 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 DRL, GRA, and FFTC, for the worldwide development and distribution of favipiravir tablets for the potential treatment and prevention of COVID-19 (excluding Japan, China, and Russia.) This consortium is designed to ensure that favipiravir 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 favipiravir 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 favipiravir clinical trials and the likelihood that such clinical trials will be initiated or consummated on the terms and timeline provided herein or at all; the anticipated timing for 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 at ). 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.
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