Detailed scientific analysis of antiviral
pipeline identifies
most promising clinical compounds aligned with 100 Days Mission
global preparedness recommendations
CAMBRIDGE, Mass., April 29,
2024 /PRNewswire/ -- 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.
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.
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
https://www.intrepidalliance.org/antiviral-clinical-pipeline.
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SOURCE INTREPID Alliance