Drs. Scott Gottlieb, Syra Madad, and Josh Schimmer Examined Scientific Milestones and Public Health Challenges That Have Defined the Global Response to COVID-19, and Important Role Appili Still Has to Play During Appili Therapeutics’ Inaugural Fireside Chat

Panelists expressed optimism for stemming the pandemic and stressed the need for sustained planning and investment in public health preparedness

Appili remains committed to advancing through Phase 3 study for an oral antiviral targeting COVID-19 treatment

Appili Therapeutics Inc. held the first event in its fireside chat series examining infectious diseases on Wednesday, March 3. The webinar “In-Dialog with COVID-19 Thought Leaders” included experts in regulatory, clinical, epidemiological, and business operations that have significantly influenced the pandemic response. A recording of the webcast on the ‘Events and Presentations’ page of Appili’s website here through March 10, 2021.


Critical Need to Improve Pandemic Preparedness for the Future


Much of the discussion focused on the need to improve pandemic preparedness for the future.* Former FDA Commissioner Dr. Gottlieb discussed the available options for medical professionals to treat COVID-19 patients, noting “We should be able to drug this virus. There’s still a real need for a small molecule solution as an important hedge against mutations and an unpredictable virus that continues to evolve more rapidly than we can [follow]. We have the therapeutic antibodies, we've got vaccines in record time, and now we need small molecule inhibitors of viral replication. They are the third leg of the stool [in our recovery.]” He also stated, “Now we're seeing the new [COVID-19] variants and I think some of those are the risks to continued recovery into the fall, but hopefully we have a bigger toolbox [by then].”


Dr. Madad, who is a senior director for the system-wide special pathogens program at NYC Health + Hospitals, focused on the need for sustained preparedness. “We need to pivot from a ‘just in time’ mentality to a ‘just in case’ one, and look at infectious disease and public health preparedness like military or national security readiness. This pandemic showed us that speed and scale are so, so important. Even a [small] delay in reacting translates into more infections and more deaths. We need to build infrastructure that has more flexibility, from the workforce, informatics, surveillance, and a healthcare system so we can respond accordingly.”


Shifting Our Focus to Protecting the Healthcare System


“If there's one lesson from all of this, it's that we have to start being prepared, and not waiting for the problem to exist before having solutions,” said Dr. Schimmer. “We could do a much better job being prepared for plausible and realistic possibilities. At the moment we’re looking at the variants and whether they can break through some of the herd immunity that we are gradually establishing. And now that we know more about the virus, we should be shifting our focus from the total infection counts to the severe infection counts, with the goal of continually reducing the latter.”


In discussing the challenges of the past year, panelists also noted many of the positive aspects that helped the global medical and public health community during the pandemic. Dr. Madad expressed gratitude for the medical professionals and staff on the frontlines, stating, “Hospitals have done an amazing job throughout the nation to meet this challenge, [the] influx of patients, expanding testing capabilities that stood up within hospitals, expanding bed capacity…and we need to look at how we can harvest the momentum right now, and make sure that we're prepared not just for COVID-19, but also moving forward, for the other outbreaks we might face.”


Innovations at the Right Time and Place


“Science got it right,” said Dr. Josh Schimmer. “It’s really incredible that before [COVID], the fastest timeline for vaccine development was about four years. We did it in under a year thanks to wonderful innovation that was at the ready, and we were able to jump on unmet need quickly. I anticipate that we’ll spend the second half of this year continuing the recovery, and then hopefully the ‘Roaring 20s’ can start in 2022.”


Dr. Gottlieb noted the technologies behind the scenes that formed the backbone of viral testing, tracing, and research. “The incorporation of sequencing to augment the traditional tools of epidemiology worked well, to look at patterns of spread, to try to deduce the societal compartments in which spread is occurring…If this had happened 15 years ago, we couldn't have developed the [tracing infrastructure] and antibody drugs as rapidly as we did and scale their production.”


Dr. Armand Balboni, CEO of Appili, moderated the event. Following the conclusion of the panel, he noted, “I’m relieved to hear from this esteemed panel that there is cause for optimism and consensus around the need for more options in our pandemic response toolbox. I heard that we must continue to pursue new technologies for vaccine discovery, invest in the rapid development of small molecule inhibitors of viral replication, build capacity to quickly manufacture biologics and disease modifying therapeutics, and, above all, ensure that science wins as we seek to unravel the course of these deadly diseases. Changes to how we conduct clinical trials during a pandemic and leveraging the intelligence community to provide actionable medical intelligence, as well as moving from ‘just in time’ to ‘just in case’ public health preparedness could provide those crucial tools. We can learn from this experience to move more quickly and efficiently the next time we face an emerging, or re-emerging, infectious disease. Some say we may never be the same after this pandemic, and I think that this panel would agree that such change is in our best interests to deal with future outbreaks.”


Resources Available Via Electronic Press Kit


The electronic press kit for this event, which includes speaker bios and headshots, is available here. The Company invites those interested to connect with Appili through its website for any questions or thoughts on a follow-up to the initial event.


About The Fireside Chat Series

Appili plans to host a series of webinars with infectious disease experts this year. This first event, ‘In-Dialog with COVID-19 Thought Leaders,’ included the following speakers:

  • Dr. Scott Gottlieb, a physician who served as the 23rd Commissioner of the U.S. Food and Drug Administration(FDA), resident fellow at the American Enterprise Institute, and partner at the venture capital firm New Enterprise Associates

  • Dr. Syra Madad, Senior Director, System-wide Special Pathogens Program at NYC Health + Hospitals; Fellow, Belfer Center for Science and International Affairs, Harvard Kennedy School at Harvard University

  • Dr. Josh Schimmer, Biotech Equity Research Analyst, Senior Managing Director, Evercore ISI’s Biotech Team

  • Dr. Armand Balboni, CEO of Appili Therapeutics; former U.S. Army officer at USAMRIID, military fellow at the FDA, active-duty faculty member at the United States Military Academy at West Point, and founding partner at Bloom Burton & Co


Appili has joined Dr. Reddy’s Laboratories LTD., Global Response Aid, and FUJIFILM Toyama Chemical in the global development and distribution of oral COVID-19 therapeutic candidate AVIGAN® / REEQONUS™ (favipiravir). The Company is sponsoring the only global study to evaluate favipiravir, an oral small molecule antiviral, as a treatment for early-to-moderate COVID-19 in the community setting. As a shelf-stable oral tablet, favipiravir may have advantages over other currently approved treatments, which require injections or intravenous administration.


Appili plans to announce future events and speakers in the fireside chat series throughout the year.


* Comments from the webinar were lightly edited for style and flow.


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