Why READDI Inc.?

By READDI, October 16, 2023 — The question comes up all the time.

Given that the READDI AViDD Center has already 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.

Innovative business model for combating Disease X

The Carolina-based READDI AViDD Center is one of nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern established by a $577 million award from the NIH in 2022. As the name implies, this is discovery work, the earliest steps in inventing new medicines. It 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 the READDI AViDD Center — 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 short duration. A short course of a drug will eliminate a condition. It’s curative. A drug that sells to sick people in regimens of around 20 pills at a time — and then you’re 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 U.S. 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.

And the goal is achievable. The scientific know-how exists. Funding it may be the greater challenge. 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 FDA-approved therapeutics. The very nature of NIH funding has resigned many academics to hitting the gap and throwing up their hands. 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 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 due to lab leak or intentionally weaponized. The DOD has an incentive to bridge the gap.

NGOs 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, 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. Small molecule antivirals are affordable, shelf-stable and capable of being 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 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 implementor to coordinate all the potentially 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 the 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.

You know what’s 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 the initiative is laser-focused on discovering and developing broad-spectrum small molecule antiviral drugs to decrease illness, hospitalization and death caused 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 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.