Appili Submits Protocol for a Phase 3 Study Evaluating Favipiravir for the Treatment of Patients with COVID-19 Infections to the US FDA
Company is committed to evaluating use of the broad-spectrum antiviral in the early treatment setting of COVID-19 to shorten the time to clinical recovery in adult patients with mild to moderate symptoms
Investigators plan to recruit 826 participants in the randomized, placebo-controlled trial
Study subset will focus on favipiravir’s potential to reduce viral shedding, diminishing the period of infectiousness
HALIFAX, Nova Scotia, September 11, 2020 – Appili Therapeutics Inc. (TSXV: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that it has submitted a new protocol to its open investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) to conduct a Phase 3 clinical study evaluating favipiravir in the early treatment outpatient setting for adult COVID-19 infections. Favipiravir is a broad-spectrum antiviral administered in oral tablet form. Investigators will seek to determine if favipiravir is a safe and effective treatment for mild-to-moderate COVID-19 infections and, if administered early, may shorten the time to clinical recovery and keep the infection from progressing into the severe or life-threatening form of the illness.
“As the global incidence of COVID-19 cases continues to rise at alarming rates, and we learn more about the virus and patient demographics, it is clear that we will need multiple approaches to effectively quell this pandemic,” said Dr. Armand Balboni, Chief Executive Officer at Appili Therapeutics. “As part of this global effort, Appili has focused on the outpatient setting with the first orally available antiviral for the potential treatment of COVID-19 in adults with mild to moderate disease. We look forward to working with clinical teams to rigorously study the utility of favipiravir, helping to determine if it can help reduce the spread and inhibit COVID-19 disease progression.”
Appili’s study is designed to be a randomized, double-blind placebo-controlled, multi-center Phase 3 trial investigating the safety and efficacy of favipiravir in the early treatment outpatient setting for adult COVID-19 infections with mild to moderate symptoms. Appili plans to recruit 826 eligible participants, who are recently diagnosed as COVID-19 positive with mild to moderate symptoms, across multiple clinical trial sites in the U.S. Participants are expected to be outpatients who do not require hospitalization and who have had a positive COVID-19 test. Participants will self-administer the drug regimen in their homes, with clinical investigators monitoring them remotely. Appili expects to initiate trial recruitment in the Fall of 2020.
In a sub study, researchers intend to further examine 136 trial participants to evaluate favipiravir’s effect on viral shedding. This occurs when the virus is contagious, replicating inside the body, and is released into the environment. In this portion of the study, investigators are seeking to determine if treatment with favipiravir can shorten the period of viral shedding, thus diminishing the period of infectivity and decreasing the spread of the virus.
“Helping to reduce the time to clinical recovery and infection severity could reduce the need for invasive and costly measures such as hospitalizations,” said Yoav Golan, MD, Chief Medical Officer, Appili Therapeutics. “Reducing the duration in which a patient is contagious could help reduce secondary cases and infection spread. Our goal is to generate robust clinical data that can help determine if favipiravir can safely and effectively support these outcomes. Favipiravir’s preliminary clinical data, broad spectrum antiviral activity, and oral formulation make this an exciting candidate for early intervention and treatment against COVID-19.”
Favipiravir is a broad-spectrum antiviral in oral tablet form originally developed by FUJIFILM Toyama Chemical Inc. and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza under the name AVIGAN. Following promising clinical studies, Russia and India recently approved favipiravir-based antiviral medications for the emergency treatment of COVID-19.[i] [ii] Clinicians are conducting additional trials evaluating favipiravir as a treatment for COVID-19 in countries including Japan, China, and the United Kingdom.
About Appili Therapeutics
Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, the Company is also testing FUJIFILM Toyama Chemical Inc.’s drug favipiravir for the prevention of COVID-19 as a potential prophylaxis treatment. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. 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 scope and parameters of the proposed clinical trial in the U.S. and the likelihood that such clinical trial will be consummated on the terms and timeline provided herein or at all; and 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). 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: securing all requisite required approvals and funding for the clinical trial in the U.S.; finalizing mutually acceptable clinical trial agreement and related agreements with the applicable clinical research organizations relating to this clinical trial; site and patient enrolment; and other expectations and assumptions concerning the proposed clinical trial in the U.S. (including with respect to potential outcomes and benefits). 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 secure any requisite rights to manufacture and commercialize favipiravir in the U.S and other jurisdictions on favourable terms or at all; 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 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.
Neither the TSX Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.
Media Relations Contact:
Sam Brown Inc.
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Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics Inc.