CONTROL trial is part of Appili’s unique approach to evaluating favipiravir in early-stage disease in the community setting for those most vulnerable to COVID-19, including the elderly, those with significant comorbidities, and frontline workers
Researchers plan to enroll approximately 760 participants in the placebo-controlled study
Favipiravir is already approved for emergency treatment of COVID-19 in several countries
Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the "Company" or "Appili"), a biopharmaceutical company focused on anti-infective drug development, today announced that investigators enrolled and dosed the first cluster of participants in Appili’s CONTROL COVID-19 clinical trial. Appili is sponsoring the Phase 2 cluster-randomized placebo-controlled trial (cluster-RCT) evaluating the effectiveness of favipiravir as a preventative measure against COVID-19 outbreaks in long-term care (LTC) facilities. This Phase 2 trial is an integral part of Appili’s broader clinical program aimed at evaluating early administration of favipiravir to limit the spread and severity of COVID-19 in high-risk patients, including the elderly.
Under the trial protocol, once an outbreak is confirmed via a PCR (nasal swab) test in an LTC facility unit, all consenting residents in that unit (cluster) will receive either favipiravir or a placebo. Dr. Allison McGeer, senior clinician scientist at Sinai Health’s Lunenfeld-Tanenbaum Research Institute (LTRI) in Toronto, is the study’s primary investigator. Researchers plan to conduct the trial at 16 LTC centers throughout the course of the study. The study population will include elderly subjects with co-morbidities and front-line healthcare workers with recent COVID-19 exposure or confirmed infection. Appili expects to report topline data from the study in 2021. The primary outcome will be control of the outbreak, defined as no new microbiologically confirmed cases of COVID-19 for at least 24 consecutive days.
"Providing early access for vulnerable patients to antiviral therapy, particularly in a community setting, is a cornerstone of Appili’s COVID-19 clinical strategy. We believe favipiravir’s mechanism of action and oral tablet formulation will best serve patients in these conditions," said Yoav Golan, MD, Chief Medical Officer at Appili Therapeutics. "Dosing the first cluster of participants in our COVID-19 trial is an important milestone for Appili’s program. Our clinical strategy has a strong potential to show a benefit in this population and truly differentiates Appili’s program from other approaches."
Favipiravir is a broad-spectrum antiviral in oral tablet form developed by FUJIFILM Toyama Chemical (FFTC) 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 FFTC recently announced positive Phase 3 data in the use of AVIGAN in hospitalized COVID-19 patientsiii. Researchers are conducting additional trials evaluating favipiravir as a treatment for COVID-19 in several countries, including the United States, China, India, and the United Kingdom. Unlike most other interventions that researchers are evaluating in the COVID-19 indication, favipiravir has already been thoroughly studied in human trials and has a known safety profile, with over 3,000 subjects receiving at least one dose of the drug. Favipiravir’s oral tablet form may also provide advantages in the community setting over other approaches to addressing COVID-19, which often require injection or intravenous administration.
"Appili was built to solve infectious disease problems, and we believe that favipiravir has the potential to be an important part of the arsenal that ultimately addresses this coronavirus pandemic," said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. "Beginning the rigorous evaluation of favipiravir in patients for COVID-19 indications is an important step for the program, and we are proud to work with our partners, including those at Sinai Health, to continue advancing our COVID-19 clinical program."
Update on APLI Shares in Escrow
As previously announced, on September 16, 2020, the Class A common shares of the Company (the "Common Shares") ceased trading on the facilities of the TSX Venture Exchange and commenced trading on the Toronto Stock Exchange (the "Graduation.") As a result of the Graduation and pursuant to the terms of the escrow release agreement between the Company, Computershare Investor Services Inc., and certain security holders of the Company dated June 12, 2019, the release from escrow of certain Common Shares and options to purchase Common Shares (the "Options") will be accelerated. As such an aggregate of 5,317,834 Common Shares and 835,688 Options currently held in escrow will be released on or about October 30, 2020; and the final 3,798,451 Common Shares and 328,715 Options will be released from escrow on or about December 29, 2020. The number of outstanding Common Shares will not change as a result of the escrow release.
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 and the likelihood that the clinical trial will be consummated on the terms and timeline provided herein or at all; the timeline for reporting topline data; and the potential use of favipiravir as a prophylactic or early treatment agent for the treatment of COVID-19. 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 approvals and funding for the clinical trial; finalizing a 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 (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 Canada on favourable terms or at all; unforeseen events, developments, or factors that may prevent the Company from completing the proposed clinical trial on the terms and timeline provided herein or all or that would cause 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.
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Appili Therapeutics Inc.