Health Canada Clears Appili Therapeutics’ Phase 2 Clinical Trial Evaluating Favipiravir as a Prophylactic Agent Against COVID-19 Outbreaks

• Appili program designed to address the most urgent aspects of the COVID-19 public health threat
• First clinical study to examine the use of favipiravir for COVID-19 outbreak control; National Institute on Ageing estimates over 80 per cent of COVID-19 deaths in Canada are occurring at long-term care facilities
• With drug donated by FUJIFILM Toyama Chemical, Appili will conduct the trial with infectious disease specialists at Sinai Health in Toronto, the University of Toronto, Sunnybrook Health Sciences Centre, and Unity Health Toronto

HALIFAX, Nova Scotia--(BUSINESS WIRE)-- Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that Health Canada provided regulatory clearance for Appili’s Phase 2 study evaluating FUJIFILM Toyama Chemical’s (FFTC) favipiravir as a preventative measure against COVID-19 outbreaks. Dr. Allison McGeer, senior clinician scientist at Sinai Health’s Lunenfeld-Tanenbaum Research Institute in Toronto, Ontario is the study’s primary investigator. Appili expects trial recruitment to begin imminently. Researchers will enroll approximately 760 subjects, both residents and staff, at 16 long-term care homes (LTCHs) in Ontario. The National Institute on Ageing has estimated that as of May 6, 2020, 82 percent of deaths related to COVID-19 in Canada were associated with long-term care facilities.ⁱ

“Given the severity of COVID-19 amongst the elderly, and the evidence of ongoing transmission with severe outcomes in LTCHs, it is critical to develop interventions that minimize the spread of disease in this setting. As vaccines and treatment for COVID-19 remain unavailable, we must explore all possible solutions,” said Dr. McGeer. “We look forward to working with Appili on this study, as the pandemic continues to present devastating consequences for LTCH residents and their families.”

The Trial

The partially blinded, cluster randomized placebo-controlled trial (cluster-RCT) will recruit approximately 760 participants across 16 LTCHs in Ontario. Investigators from the University of Toronto, Sunnybrook Health Sciences Centre, and Unity Health Toronto are also participating in the study. The primary objective of the Phase 2 trial is to evaluate the efficacy of favipiravir or 25 days compared with placebo as a prophylaxis to prevent COVID-19 outbreaks in LTCHs. The primary endpoint will be outbreak control, defined as no new cases of COVID-19 in residents for 24 consecutive days up to Day 40 after the start of prophylaxis. Secondary objectives include measures of safety, rates of infection, disease progression, and fatality rates.

“With the strikingly high fatality rate from COVID-19 in long-term care facilities, there is a particularly urgent need to protect our most vulnerable members of society. Preventing and controlling COVID-19 outbreaks in long-term care facilities is therefore of extreme importance,” said Yoav Golan, MD, Chief Medical Officer at Appili Therapeutics. “Industry and academia are coming together in unprecedented ways to mitigate this crisis, and Appili is proud to be part of this unique collaboration. Dr. McGeer and her team at Mount Sinai, along with our other medical partners from some of the premier institutions in Toronto, have extensive experience in working to mitigate respiratory infections in long-term care settings. Together with the support from FFTC, we are in a unique position to evaluate the utility of favipiravir as a COVID-19 prophylaxis to control further outbreaks in these facilities, which could be a significant advance for Canadian patients, with implications for global application in similar high-risk outbreak settings.”

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time.

Favipiravir

Favipiravir is a broad-spectrum antiviral approved in Japan under the brand name Avigan. Japanese health authorities provided approval to FFTC in 2014 to use Avigan as a treatment and stockpile countermeasure for pandemic influenza outbreak. Recent studies suggest favipiravir may have potential utility for the treatment of COVID-19.^{ii iii} Researchers in Wuhan, China, reported in early February that favipiravir demonstrated anti-viral activity in vitro against SARS-CoV-2. Small-scale clinical trials conducted in China have also indicated that favipiravir may provide clinical benefit in patients with COVID-19.

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. 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; and the potential use of favipiravir as a prophylactic 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 required 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; 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 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 July 3, 2019 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.

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.

ⁱ MacCharles, Tonda. 82% of Canada’s COVID-19 deaths have been in long-term care, new data reveals. The Star Accessed online May 7, 2020.

ⁱⁱ Cai et al (2020) Experimental Treatment with Favipiravir for COVID-19: An Open-Label Control Study. Engineering. https://doi.org/10.1016/j.eng.2020.03.007

ⁱⁱⁱ Chen et al (2020) Favipiravir versus arbidol for COVID-19: A Randomized Clinical Trial. medRxiv preprint doi: https://doi.org/10.1101/2020.03.17.20037432

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