November 13, 2023

Given that READDI’s Antiviral Drug Discovery (AViDD) Center (READDI-AC) already has raised more than $130 million from the National Institutes of Health (NIH), the North Carolina General Assembly, RTI International and others — money that’s funding important drug discovery research in leading labs across North Carolina and around the globe — what role does READDI Inc. play?

For starters, READDI is a broad initiative. That’s what the “I” stands for in Rapidly Emerging Antiviral Drug Development Initiative, though it might as well stand for “innovation.” 

Meeting the incredibly complex challenge of developing antiviral drugs before Disease X emerges demands leading-edge science, yes — but also business creativity, bold action and commitment. (See “READDI’s ‘one drug, many bugs’ solution” below for more on the science.) 

READDI, the initiative, was strategically structured to meet the challenge and make the world safer. 

READDI Inc., a nonprofit biotechnology company, plays a critical role in that effort. 

An innovative business model for combating Disease X 

Previously, the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, awarded the UNC Gillings School of Global Public Health a $65 million grant, part of a $577 million award, establishing READDI-AC to develop oral antivirals that can combat pandemic-level viruses like COVID-19.  

The center builds upon and is tightly affiliated with UNC’s Rapidly Emerging Antiviral Drug Development Institute (READDI). 

 As the name implies, READDI-AC focuses on discovery — the earliest steps in inventing new medicines. The work involves research to identify and validate novel viral targets, with an eye toward small molecules that directly block how viruses hijack cells. 

But the promising discovery work coming out of READDI-AC— and the eight other university-led AViDD centers — will never progress beyond interesting research findings in peer-reviewed journals without a big push to turn the corner from discovery into development. 

Historically, antiviral drug development has not been commercially attractive. Most infectious diseases are acute, meaning severe and of short duration. A quick course of a drug will eliminate a condition. 

The issue is that a drug that sells to sick people in regimens of around 20 pills at a time — and then you’re completely cured — isn’t nearly as lucrative as a prescription to treat a chronic disease that’s refilled every month indefinitely. 

All drug development involves financial risk. When it comes to antiviral drugs for pandemic preparedness — to fight diseases that don’t yet exist — there is no established business model, no chartable 12-year horizon from first research dollar spent to peak revenues. 

But the effort is absolutely necessary. The United States alone suffered 1.1 million COVID deaths — 60% more than all U.S. combat deaths since 1775 — and $14 trillion in economic losses.  

Worldwide, COVID has killed an average of 6,200 people every single day for the past three-and-a-half years. 

Still, the goal of eliminating it is achievable. The scientific know-how exists. Funding it may be the greater challenge, and that’s where READDI Inc. comes in. 

Bridging the gap 

There has long existed a translational gap between drug discovery and development, between academic research and therapeutics approved by the Food and Drug Administration. 

The very nature of NIH funding has resigned many academics to throwing up their hands when they hit the gap, but that cycle must change. The world can’t afford another COVID-19 scenario.  

So, READDI Inc. is de-risking the earliest stages of drug development to bridge a gap so treacherous it’s known as the “Valley of Death.”  

How? By convening a global consortium of funders with different interests and incentives, including the profit-minded. 

Federal governments around the world, for instance, measure return on investment in lives saved and economic catastrophes avoided. Billions spent to create a bulwark of antiviral drugs to protect against all high-risk virus families can save trillions in direct pandemic recovery payments. Governments have an incentive to bridge the gap. 

Just as the U.S. Department of Defense (DOD) invests in preparedness against air and sea attack, it also invests in biosecurity countermeasures against viral outbreaks. It doesn’t matter whether the outbreak is naturally occurring, unintentional or weaponized. The DOD has an incentive to bridge the gap. 

Meanwhile, NGOs (nonprofit organizations) and foundations appreciate the fact that READDI Inc. is a mission-driven nonprofit that shares their dedication to equitable global access. Thirty percent of the world’s population remains unvaccinated against COVID-19, while wealthy countries are providing seasonal boosters to anyone who wants one.  

Affordability and inadequate distribution systems in low-income countries are part of the problem. So is the lack of refrigeration for vaccines. Small molecule antivirals, however, are affordable, shelf-stable and more easily shipped to everyone, everywhere when the next pandemic threat arises. Equity-minded groups have an incentive to bridge the gap. 

Bridging the gap in drug research and development (R&D) is not a new concept, of course, but it’s happening piecemeal. In the underfunded field of antiviral drugs, multiple entities compete for limited resources.  

Pandemic preparedness calls for efficient consolidation. READDI Inc. is positioning itself as a core coordinator of many disparate programs under the auspices of a single, trusted nonprofit. 

READDI Inc.’s goal is to de-risk the assets — the promising compounds coming out of academic labs — to the point where financial investors and pharmaceutical companies want to invest. 

At that point, READDI Inc. will create an equity structure for each asset that meets the interests of all stakeholders — researchers who hold intellectual property rights, investors seeking financial returns, governments that want preparedness stockpiles and foundations fighting for equitable access agreements. 

As brilliant, hardworking scientists progress in their discovery, generating molecules with the potential to stop infection and replication in high-risk virus families, READDI Inc. keeps that research alive by raising funds to move those assets into drug development. 

Because what is more treacherous than the R&D Valley of Death? 

Doing nothing and being caught flatfooted by the next catastrophic pandemic. 

READDI’s ‘one drug, many bugs’ solution READDI graphic with a close-up of a blue circle with multicolor smaller circles around it.

READDI the initiative is laser-focused on discovering and developing broad-spectrum small molecule antiviral drugs to decrease illness, hospitalization and death caused by Disease X. 

These are pills that can be shipped immediately, without refrigeration, to the point of outbreak and taken orally. 

Learn more about how READDI develops drugs for diseases that don’t yet exist. This “one drug, many bugs” solution exploits the Achilles heel of viruses — the fact that all viruses in a given family share common, inherited methods for hijacking cells. 

If the world stockpiles antivirals that target the half-dozen most threatening virus families, we can stop pandemics in their tracks, preventing health emergencies, systemic shutdowns and the economic and societal fallout that follows. 

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