New Data Show Gaps in Antiviral Pipeline Against High-Risk Viral Threats
Longitudinal analysis reveals clear gaps in global preparedness against emerging viral threats and future pandemics.
The research was published by the INTREPID Alliance of global R&D-based pharmaceutical companies and affiliates, in the fifth edition of its Antiviral Clinical and Preclinical Development Landscape, a comprehensive analysis of the global pipeline of small-molecule antiviral compounds.
The analysis shows that:
- Only 8 viral disease indications are currently in clinical evaluation across 6 of the 14 high-risk viral families, likely representing the only potential new small-molecule antiviral treatments in the next 4-5 years.
- While 11 of the 14 viral families have compounds in preclinical stages, expected attrition and the time required to advance through R&D stages means that many viruses risk remaining without approved treatments for years to come.
- Significant gaps persist, with no ongoing clinical or preclinical novel antiviral activity in 3 high-risk viral families: Adenoviridae, Hantaviridae, Peribunyaviridae.*
Alongside these findings, the data do show limited progress in preclinical antiviral R&D, including expanding efforts to explore the broad-spectrum potential of existing antivirals to help address existing gaps in global preparedness against viral threats.
Emerging and endemic viruses continue to present a constant risk to the global community. Last year, the world monitored closely as Ebola virus and Marburg virus disease outbreaks occurred in
Key Landscape Findings
INTREPID's longitudinal analysis of the antiviral R&D pipeline shows more than a 2-fold increase in the number of distinct preclinical compounds for Non-COVID-19 indications (reaching 65 versus 29 previously) during the past 18 months, some of them resulting from the work of the NIH-funded AViDD centers. The number of investigational clinical compounds has remained relatively stable for both COVID-19 and Non-COVID-19 viral indications at 27 and 18 distinct compounds, respectively. Indication Expansion evaluations exploring potential broad-spectrum activity against Non-COVID-19 viral diseases have also grown over time, and 3 new influenza antivirals have been approved in
"Recent outbreaks — from Marburg to Nipah to hantavirus — are a stark reminder that the world remains vulnerable to existing and emerging viral threats," said
The Urgent Need to Catalyze Change
Medical countermeasures, such as antivirals, provide significant advantage in response to pandemics and viral outbreaks by allowing for faster response time to new and emerging outbreaks as well as helping to mitigate the severity of an outbreak by reducing hospitalizations, transmission, and mortality rates.
A significant increase in R&D investment and activity is needed to fill the pipeline gaps. Government and philanthropic funding play a critical role in helping to de-risk early-stage R&D, which in turn can attract the private investment needed in advance of the next outbreaks. Some new funding is available, including from the NIH-funded AViDD centers; the SMART Antiviral Prize from BARDA focused on broad-spectrum activity against Togaviridae and Flaviviridae families; the European Commission's DG HERA investment focused on new treatments for dengue; Horizon Europe's funding for the development of small-molecule antivirals for pathogens of epidemic potential; and the Pandemic Antiviral Discovery (PAD) initiative from Novo Nordisk Foundation and others. In addition, economic pull incentives such as stockpiling and advance purchase agreements, which would attract further private investment, are lacking and would benefit from a long-term and strategic approach.
Antiviral R&D Program Leads
In this recent landscape update, biotech and pharmaceutical companies dominate clinical-stage development, accounting for 89% of R&D leads. Most preclinical antiviral research is led by research institutes (71%) alongside the biopharmaceutical industry (29%). R&D programs across both clinical and preclinical are based in 40 different countries with clinical development leading from the
"Antiviral medicines play a critical role in strengthening global health security. It is imperative that we seize this opportunity to advance the innovative research underway all around the world to address this unmet need," said Kelly Chibale, Ph.D., Professor,
Enhanced Antiviral Toolkit for the Global Research Community
A groundbreaking and newly published report on In Vitro Assays and Animal Efficacy Models for Orthoflaviviruses, is also available to provide foundational resources and guidance to researchers actively pursuing discovery of novel antivirals to address the gaps in the pipeline.
Through the INTREPID Antiviral Toolbox, researchers have access to a focused collection of tools and publications, including a Registry of Antiviral Compounds Libraries, to help catalyze the identification and development of small-molecule antivirals.
INTREPID's antiviral pipeline reports and broader antiviral toolbox are a key contribution to the 100 Days Mission and the recently announced Therapeutics Development Coalition, whose aims are to be prepared as much as possible so that within the first 100 days of a new pandemic threat being identified, interventions can be made available, safe, effective, and affordable.
INTREPID's research is freely available and is intended to support policymakers, funders, and the global scientific community in identifying the most urgent needs and highest-impact opportunities in antiviral R&D.
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 non-profit consortium of innovative biopharmaceutical companies and affiliates committed to accelerating the development of antivirals for epidemic and pandemic threats. Through independent landscape analysis and policy engagement, the Alliance supports science-based investment and preparedness strategies aligned with global public health goals.
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 affiliates 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
* | Excludes approved antivirals or indication expansions. | |||||
1 | World Health Organization. Disease Outbreak News: Ebola virus disease – | |||||
2 | World Health Organization. Disease Outbreak News: Marburg virus disease – | |||||
3 | BBC. Nipah virus outbreak in | |||||
4 | World Health Organization. Disease Outbreak News: Hantavirus cluster linked to cruise ship travel, Multi-country. | |||||
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SOURCE INTREPID Alliance
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