New INTREPID Alliance Antiviral Landscape Report Highlights Urgent Need to Bolster R&D Pipeline in Support of Global Pandemic Preparedness Efforts

Current mpox outbreak underscores gaps in access to medical countermeasures to help mitigate the severity of future outbreaks

CAMBRIDGE, Mass., Oct. 9, 2024 /PRNewswire/ -- Today, the INTREPID Alliance, a consortium of innovative biopharmaceutical companies dedicated to accelerating antiviral treatments to help protect the world ahead of future pandemics, released its Antiviral Clinical and Preclinical Development Landscape. In this third edition report, the Alliance adds a list of preclinical antiviral compounds to its ongoing analysis of clinical antiviral compounds in development that target the 13 viral families identified¹ as having potential to result in a pandemic which now includes mpox.

INTREPID's analysis shows that the majority of the 64 distinct direct-acting antiviral compounds in clinical phase studies target coronaviruses (SARS-CoV-2) and orthomyxoviruses (Influenza). Similarly, of the 96 distinct preclinical direct-acting antiviral compounds spanning the different stages of preclinical development, the majority target SARS-CoV-2 (COVID-19). Non-COVID-19 preclinical compounds under study are primarily targeting Influenza. Further analysis reveals that there is no preclinical development activity found for 3 of the 13 viral families (Nairoviridae, Peribunyaviridae, and Picornaviridae), and no clinical development activity was found in 4 of the 13 viral families (Hantaviridae, Peribunyaviridae, Paramyxoviridae, and Togaviridae).

These key findings in today's report highlight an urgent need for increased research and development in antivirals beyond the concentration in COVID-19 and Influenza research in order to enable a strong global preparedness and response system in the face of future pandemics.

"Antiviral medicines play a critical role in the world's arsenal to prevent and respond to emerging and neglected viruses with pandemic potential," said James Anderson, Executive Director of Global Health at the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and Chair of the INTREPID Alliance Board. "INTREPID's analysis identifies the critical gaps that currently exist in the antiviral R&D pipeline, and where we can work together with our collaborators and partners to shine a light on potential areas of focus that can strengthen our global preparedness efforts when future outbreaks emerge."

Medical countermeasures, such as the use of antivirals, provide significant advantage in response to pandemics by allowing for faster response time when a new outbreak occurs as well as helping to mitigate the severity of an outbreak by reducing hospitalizations and mortality rates.

The current mpox outbreak and the World Health Organization (WHO) declaration of mpox as a public health emergency of international concern,² underscores the urgency to prepare against new and known viral threats where we have identified risks. Included in today's report is information specific to the clinical and preclinical R&D landscape for mpox, which shows critical gaps in compound discovery and development for mpox and related poxviruses.

"Greater transparency from INTREPID's landscape into the antiviral drug pipeline is instrumental in coordinating global preparedness efforts across developers, funders, governments, and the broader global public health community," said Jeremy Farrar, Ph.D., Chief Scientist, World Health Organization. "The current mpox outbreak, as well the alarming rise in dengue infections, show us that we cannot rely solely on the current pipeline when facing viruses of global concern. Stakeholders from the public and private sectors need to work together to fill in these significant gaps in the antiviral pipeline."

About the INTREPID Alliance Antiviral Landscape

The INTREPID Alliance Antiviral Clinical and Preclinical Development Landscape – 3^rd Edition is a comprehensive landscape analysis based on publicly available information³ with the aim to aid in the identification of clinical (e.g., Phase 2/3 ready) and preclinical antivirals aligned with the 100 Days Mission and the International Pandemic Preparedness Secretariat (IPPS)⁴ in addition to highlighting gaps in the R&D pipeline.

In this most recent update, biopharmaceutical companies represent the vast majority, 92%, of the global antiviral clinical developers with development concentrated in the United States (45%) and China (35%). The majority of sponsors/developers for preclinical compounds/indications are also from the biopharmaceutical industry at 48% followed by academia/research institutions representing 47% of the total.

Sponsors/Developers of preclinical antiviral compound/indications are located in 27 countries across five of the six WHO-Regions.⁵ The Americas and Western Pacific WHO-regions are primarily driven by the United States (44%) and China (~16%). The majority of preclinical sponsors/developers are based in countries with high-income economies (82.5%) with the remainder in upper-middle (16.5%) or lower-middle (0.9%) income economies; the United States and China have the most representation in high- and upper-middle income economies, respectively.

INTREPID will continue to follow all compounds closely to inform updates to the clinical and the preclinical landscape. We welcome feedback to improve our listing, which can be provided through our online portal. As with previous listings, developers are invited to submit non-confidential information on their compound candidates. All reports are updated quarterly and based on non-confidential information.

The full landscape report, study methodology, and an interactive antiviral clinical development pipeline are available at the INTREPID website.

Disclaimer

The INTREPID Alliance is a not-for-profit consortium of innovative biopharmaceutical companies committed to accelerating antiviral research, aiming to ensure that we have a stronger pipeline and are better prepared for future pandemics.

As part of our efforts, the INTREPID Alliance maintains and publishes a centralized list of promising investigational candidate compounds, with the purpose of knowledge-sharing and to support better pandemic preparedness. These compounds have been selected based on objective, scientific criteria, using publicly available sources, and at arm's length from commercial influence of our member companies. See criteria listed in the report "Antiviral Clinical Development Landscape and Promising Clinical Compounds." The designation of certain compounds as promising is based upon currently available information, and exclusively upon an assessment against these criteria. "Promising" is not a promotional claim. Candidate compounds have not been assessed by regulatory authorities to be safe and efficacious for the treatment of disease in humans. Our content is designed to be factual, informative, and non-commercial. It is not designed or intended to advertise or promote any pharmaceutical product or therapy or to advance the commercial interests of any company.

ABOUT THE INTREPID ALLIANCE

The INTREPID Alliance aims to accelerate the development of new treatments for emerging viral pandemic agents through facilitating early science and R&D, policy and advocacy, and stakeholder engagement. Led by a not-for-profit consortium of innovative biopharmaceutical companies and working with the public, private and not-for-profit sectors, INTREPID works to bridge key gaps and unmet needs to ensure delivery of antiviral solutions to viral pathogens with the greatest pandemic potential.

The seven member companies of the INTREPID Alliance are members of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).

INTREPID was launched in March 2023 at a high-level summit bringing together more than 100 thought leaders in virology and global health. For a read-out from the summit and additional information, visit www.intrepidalliance.org.

¹ 13 priority viral families identified by the INTREPID Alliance Scientific Working Group using the NIH/NIAID priority viral family list; World Health Organization priority disease areas; and Airfinity database of antivirals.
² World Health Organization (WHO). WHO Director-General declares mpox outbreak a public health emergency of international concern. (14 August 2024).
³ INTREPID Alliance triaged a global antiviral R&D database, licensed from Airfinity, and applied stringent inclusion and exclusion criteria to arrive at the Antiviral Clinical Development Landscape. Methodology available at https://www.intrepidalliance.org/antiviral-clinical-pipeline.
⁴ International Pandemic Preparedness Secretariat (IPPS). 100 Days Mission: Implementation Report – 2023. (January 2024).
⁵ WHO Member States are grouped into six regions, each with a regional office.

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