Public health experts put out call for collaboration in antiviral therapeutics development coalition

Safe and effective therapeutics are critical when responding to a viral outbreak. But as the COVID-19 pandemic starkly highlighted, the pipeline of therapeutics for diseases with pandemic potential is bare.

Establishing a global therapeutics development coalition is a vital next step to invigorate the therapeutics pipeline and drive advocacy for increased investment and coordination of end-to-end therapeutics development, READDI CEO James Rosen and co-authors write in an Aug. 30 PLOS Global Public Health article, “The case for a Global Therapeutics Development Coalition: building a therapeutics pipeline for pandemic and endemic diseases.” A consolidated effort by stakeholders across academia, government, international organizations, civil society and the private sector would avoid duplication, eliminate waste and present a unified front to potential funders.

Rosen and his co-authors invite interested stakeholders to consider how they can contribute toward the ultimate goal of developing two Phase-2 ready therapeutics for virus families of pandemic potential.

Antiviral therapeutics reduce mortality, morbidity and overcrowding in hospitals. They offer a frontline defense while vaccines are being developed, tested and rolled out. And therapeutics are essential for diseases for which vaccine development is challenging and lengthy — or for populations who are unwilling or unable to get vaccinated.

However, among the World Health Organization’s priority pathogen families with pandemic potential, there are only approved therapeutics available for COVID-19 and Ebola Zaire and few candidates for other viral families of concern in development.

A critical lack of funding for therapeutics R&D, before and during the recent pandemic, hampered efforts to develop a timely therapeutic armamentarium for COVID-19. During the first year of the COVID-19 pandemic, 20 times less was spent globally on therapeutics R&D compared to vaccines ($4.6bn versus $91bn), and the therapeutics pillar of the Access to COVID-19 Tools (ACT) Accelerator received less than 10% of donor funding, compared to nearly 70% allocated to COVID-19 Vaccines Global Access (COVAX) for vaccines. The first oral antivirals did not become available until 20 months after the first COVID-19 vaccines, which were authorized for use in under a year.

“In future health emergencies we may not be so lucky, meaning therapeutics may well be all we have,” the authors write. After four decades of HIV research, for example, there is still no HIV vaccine. Antiviral therapeutics turned HIV-AIDS from a death sentence to a chronic manageable disease.

READDI is a core implementation partner in the IPPS’s 100 Days Mission, embraced by the G7 and G20 in 2021 to ensure the global availability of diagnostics, therapeutics and vaccines within the first 100 days of a pandemic threat. READDI is co-leading the Therapeutics Development Coalition effort, along with the International Pandemic Preparedness Secretariat (IPPS), WHO, Drugs for Neglected Diseases initiative (DNDi), IFPMA, Unitaid, INTREPID Alliance, Medicines Patent Pool and 100 Days Mission Therapeutics Working Group.

The Therapeutics Development Coalition’s goal — two Phase-2 ready therapeutics for priority pathogens — mirrors READDI’s goal. Like READDI, the coalition is focused on virus families of pandemic concern and developing broad-spectrum compounds. Equitable access must be embedded throughout the therapeutics development value chain, the authors write.

“READDI is collaborating with colleagues in discovery and development to ensure that a robust antiviral pipeline is comprised of potential therapeutics that will be affordable and accessible to everyone who needs them, where they need them, when they need them. Creating a coalition is a critical step toward meeting these goals,” says Rosen, who co-authored the article with eight others, including the co-chairs of the IPPS Science and Technology Expert Group: epidemiologist Shingai Machingaidze; and Dr. Victor Dzau, president of the National Academies of Sciences, Engineering and Medicine.

Developers and those in early-stage research are invited to express interest in joining this collaborative approach by contacting IPPS Deputy Head Sheila Mburu at info@ippsecretariat.org.

Other key points from the article:

• Rather than creating a new entity, this should be a genuine coalition of existing partners working towards the shared goal of ensuring availability and access to therapeutics.
• To guarantee equitable access is built at early stages of the R&D pipeline, the coalition will aim to establish pre-agreed pathways and templates for clinical trials (including use of already established clinical trials networks), regulation, manufacturing and procurement and advocating for investments.
• Ensuring sustained R&D funding throughout the development lifecycle will be critical.

About READDI

The Rapidly Emerging Drug Development Initiative is a global public-private partnership founded by a team of virologists from the University of North Carolina at Chapel Hill to create medicines in advance of the next catastrophic viral outbreak. Collaborating with researchers around the world, READDI acts in the public interest to make small-molecule antiviral drugs affordable and accessible to all. READDI is a core implementation partner in the 100 Days Mission, a preparedness effort embraced by the G7 and G20.