Detailed scientific analysis of antiviral pipeline identifies most promising clinical compounds aligned with 100 Days Mission global preparedness recommendations

CAMBRIDGE, Mass., April 29, 2024 – Building on its commitment to identify strengths and gaps in the R&D pipeline for antivirals, the INTREPID Alliance, a consortium of innovative biopharmaceutical companies dedicated to accelerating antiviral treatments to help protect the world ahead of future pandemics, today published the second edition of its Antiviral Clinical Development Landscape. This ongoing scientific review and triage of a global R&D database of clinical antivirals reveals concerning gaps in the development of promising clinical compounds targeting 12 viral families¹ of greatest pandemic potential.

Globalization, urban expansion, and exploitation of natural habitats increase the chances of facing new and known pathogens with the potential to cause pandemics. One recent risk model indicates a 27.5 percent chance that a pandemic as deadly as COVID-19 could take place in the next ten years.² Pandemic preparedness strategies, including medical countermeasures such as the use of antivirals, can help to mitigate the severity of a future outbreak.

“We need to prepare now to reduce the world’s risk against emerging and known viruses in the future,” 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 updated analysis shows that we have a lot of work to do to close the gaps that exist in the development of potentially life-saving treatments to address viruses identified as the biggest threats to the global community.”

Orally available small-molecule drugs that can be rapidly mobilized and distributed are a critical tool in our global defense because of their potential to treat the harmful impact of viruses, ease symptoms, and prevent hospitalizations for those infected. However, given the nature of drug development, it may require years to discover and develop new antiviral treatments. In fact, the International Pandemic Preparedness Secretariat (IPPS) as part of the 100 Days Mission priority efforts recommends the “development of at least two ‘Phase 2 ready’ therapeutic candidates against the identified viral pathogen families of greatest pandemic potential.”³

This comprehensive landscape analysis based on publicly available information⁴ intends to aid in the identification of clinical (e.g., Phase 2/3 ready) and preclinical antivirals aligned with the 100 Days Mission and highlight gaps in the R&D pipeline.

Second Edition Key Findings and Promising Clinical Compounds

The INTREPID Alliance’s second edition of the Antiviral Clinical Development Landscape identifies 60 distinct direct-acting antiviral compounds in development that together account for a total of 78 viral indications across 8 of 12 priority viral families. Of the 60 compounds, 19 are approved by a stringent authority or other national regulatory authorities and have been limited to either COVID-19 and/or influenza.

Seven of the 19 distinct approved compounds, either alone or in combination with other approved compounds, are now being studied against 13 other viral indications. These Approved-Indication Expansion antiviral compounds, which have already demonstrated an acceptable safety and tolerability profile, will be evaluated against the promising compounds criteria outlined below as more data become available.

In addition, of the 60 distinct antiviral clinical compounds, 41 are considered novel compounds in various phases of clinical development.

Upon further analysis, these 41 novel compounds were classified into three categories with:

• 11 identified as “Promising” (compounds that are “100 Days Mission Ready”);
• 26 identified as “Watch & Wait” (compounds which readiness for 100 Days Mission cannot be fully assessed at this time); and
• 4 identified as “Archived” (interesting compounds that are no longer actively being developed).

The majority of the developers and sponsors of these clinical-stage compounds are from the biopharmaceutical industry with nearly 89 percent representing the spectrum of small biotechs to large pharmaceutical companies. Antiviral developers within academia follow at approximately 11 percent, and contract research organizations represent less than 1 percent.

“We live in an interconnected ecosystem that relies on cooperation and scientific innovation across the public and private sectors to address the greatest public health challenges of our time,” said Mona Nemer, Ph.D., Chief Science Advisor of Canada and Chair of the 100 Days Mission Steering Group. “INTREPID’s antiviral landscape analysis is a clear reminder to us all that we can and must prioritize our pandemic preparedness efforts before new viral threats emerge if we are to meet the 100 Days Mission aims of averting future global pandemics.”

As a next step, INTREPID is expanding its landscape analysis to preclinical stage antiviral compounds to be inclusive of available early-stage research. All compounds will be followed closely, and both the clinical and the preclinical landscape will continue to be updated quarterly.

To improve our listing, developers are invited to submit non-confidential information on their compound candidates through our online portal. In addition, we welcome all feedback through this portal.

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

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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.

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.

CONTACT

Nina M. Hill, Ph.D., Secretariat, INTREPID Alliance, [email protected]

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1 12 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 Airfinity, Pandemic forecasting modelling: How would the world fare with a new pandemic today? (14 April 2023).
3 International Pandemic Preparedness Secretariat, 100 Days Mission: Implementation Report – 2023. (January 2024).
4 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 http://www.intrepidalliance.org/antiviral-clinical-pipeline.