Appili Therapeutics Submits CTA with Health Canada to Sponsor Prophylactic Phase 2 Clinical Trial Evaluating FUJIFILM Toyama ...

First clinical program in the world designed to assess the use of favipiravir for COVID-19 as prophylaxis for outbreak control; antiviral drug has shown early efficacy against COVID-19

Appili Therapeutics Inc. (TSXV: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, today announced that it will sponsor the first clinical trial evaluating FUJIFILM Toyama Chemical’s (FFTC) drug favipiravir for the prevention of COVID-19, a respiratory infection caused by the novel SARS-CoV-2 coronavirus. Favipiravir is approved in Japan as the anti-influenza drug Avigan. With FFTC providing support through donated drug product, the phase 2 study will be conducted at long-term care facilities in Ontario. Appili has filed the clinical trial application (CTA) with Health Canada and expects to initiate the trial as soon as possible following receipt of regulatory clearance.

“As the world races to address the COVID-19 pandemic, Appili is proud to support this endeavour that is looking at this problem specifically in Canada’s most vulnerable patients, establishing a world-class clinical program and significant contribution to the global dataset that is needed to help address this crisis,” said Armand Balboni, MD, PhD, Chief Executive Officer, Appili Therapeutics. “Appili was built to tackle the most urgent needs in infectious diseases in innovative ways that no other organization could or would be willing to take on. This program illustrates our commitment to leverage our relationships and expertise to do the right thing for patients and public health.”

Favipiravir is a broad-spectrum antiviral developed by FFTC and approved in Japan under the brand name Avigan. Japanese health authorities provided approval to FFTC in 2014 to use Avigan as a treatment in a pandemic influenza outbreak. Favipiravir was also used in a clinical trial to address the Ebola outbreak in Guinea. FFTC is actively supporting several controlled clinical trials for favipiravir to investigate its use against COVID-19. Recent studies suggest favipiravir may have potential utility for the treatment of COVID-19.i ii Researchers in Wuhan, China, reported in early February that favipiravir demonstrated anti-viral activity in vitro against SARS-CoV-2. Small-scale trials conducted in China have also indicated that favipiravir may provide clinical benefit in patients with COVID-19.

“We have an ongoing relationship with Appili and are pleased to support the company in its efforts to assess favipiravir for the potential benefit of Canadian patients,” said Junji Okada, President of FFTC. “We are well-aligned with Appili in our commitment to innovative R&D work that may address public health crises by mitigating the threat of deadly infections.”

The cluster randomized placebo-controlled trial (cluster-RCT) will recruit patients at multiple long-term care facilities throughout Ontario. The primary endpoint will be the safety and efficacy of favipiravir in the prevention of further outbreak in long-term care facilities. Secondary endpoints will assess favipiravir’s potential to inhibit disease progression in this subject population. As of May 2020, the majority of deaths in Canada resulting from COVID-19 have occurred in long-term care facilities, making this population especially vulnerable to the pandemic.

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, parameters and particulars 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. 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 regulatory approvals (including Health Canada approval) 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; the state of the current market conditions and their anticipated impact on the Company’s business; and other expectations and assumptions concerning the proposed clinical trial. 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 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

ii 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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