Global landscape analysis identifies strengths and gaps in R&D pipeline 
to inform international pandemic preparedness efforts

ROME and CAMBRIDGE, Mass., Jan. 24, 2024 /PRNewswire/ -- The INTREPID Alliance, a consortium of innovative biopharmaceutical companies dedicated to accelerating the development of antiviral treatments to help protect the world ahead of future pandemics, today published the first phase of its global landscape assessment of antiviral research and development (R&D). Antivirals are a critical part of the world's collective defense against new and known viruses. This research is intended to contribute to global pandemic preparedness efforts, including delivering on the 100 Days Mission set forth by the G7.

The INTREPID Alliance was formed to bring together the collective industry expertise of its members across drug discovery, antiviral R&D, and medicine manufacturing to help prioritize the most promising assets in the drug development pipeline, support their advancement and catalyze new partnerships to fill in the gaps. This landscape analysis provides an initial look at the antiviral compounds currently under investigation that target 12 viral families selected by INTREPID with the greatest pandemic potential.

Key Findings: Antiviral Clinical Development Landscape

This initial release of the INTREPID Alliance's Antiviral Clinical Development Landscape identifies 80 clinical programs including 61 unique compounds for nine of the 12 priority viral families.¹ Of the 61 compounds, 19 are approved by stringent authority or other national authority, 26 compounds are undergoing clinical phase of development from Phases 1-3. And 16 of the 61 compounds are undergoing further information gathering by INTREPID.²

Of the 26 compounds being actively developed, all but five target coronaviruses (SARS-CoV-2) and orthomyxoviruses (Influenza) with less focus on other respiratory or vector-borne viruses of concern. In addition, several of the 19 approved compounds are also being evaluated for other viral indications.

Other indications that have 1-3 compounds under development or approved include Human Adenovirus (A-G), Lassa fever, Chapare hemorrhagic fever, Ebola, Dengue, Japanese encephalitis, Crimean Congo hemorrhagic fever, Hendra virus, Rhinovirus, and Polio. Viral families with no compounds currently in clinical development are Hantaviridae, Peribunyaviridae, and Togaviridae.

The majority of the developers and sponsors of these clinical-stage compounds are from the biopharmaceutical industry with nearly 88 percent representing the spectrum of small biotechs to large pharmaceutical companies. Antiviral developers within academia follow at approximately 8 percent, contract research organizations at 3 percent, and government at approximately 2 percent.

"One of the many lessons from the COVID-19 pandemic is that we need to be better prepared, particularly related to the development of novel antiviral therapies that can help to treat the harmful impact of viruses, ease symptoms, and shorten the length of infection," said James Anderson, Executive Director of Global Health at the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and Chair of the INTREPID Alliance Board. "While researchers in the industry and elsewhere continue to make progress, this landscape shows that significant gaps exist. We have the opportunity to build on the legacy of collaboration coming out of the recent pandemic to prioritize innovation in the antivirals pipeline and protect the world ahead of future pandemics."

Coordination Across the Global Community

In support of global pandemic preparedness efforts, INTREPID leadership joined the International Pandemic Preparedness Secretariat (IPPS) today in Rome for the launch of the 100 Days Mission Therapeutics Roadmap. A cornerstone of the IPPS's plan is the development of at least two 'Phase 2 ready' therapeutic candidates against the identified viral pathogen families of greatest pandemic potential.³ INTREPID's ongoing commitment to monitor and evaluate the wide range of antiviral compounds in development through its landscape analysis will continue to provide critical data in support of this goal.

"Antiviral therapeutics are a critical component in our defense against new and emerging pandemic threats," said Victor J. Dzau, M.D., Co-Chair of the 100 Days Mission Science and Technology Expert Group. "The INTREPID Alliance's analysis of the current antiviral landscape will serve as a launchpad and continue to focus the global community on areas of urgent need and priority."

Adding to this initial focus on compounds in clinical development, INTREPID is currently expanding its landscape analysis to include preclinical stage compounds. As a next step, later this year, INTREPID will publish a list of promising Phase-2 ready compounds that can be quickly deployed as antiviral compounds derived from the global landscape and scientific inspection.

To improve our listing, developers are invited to submit non-confidential information on their compound candidates through an online form at the INTREPID website. The full landscape report and data are also publicly available at the INTREPID website and will be updated quarterly.

The INTREPID Alliance actively engages with policymakers and public health bodies to ensure that antivirals are incentivized and integrated appropriately into global and local efforts to be better prepared against future pandemics.

GLOBAL DATABASE AND STUDY METHODOLOGY

The INTREPID Alliance triaged a global antiviral R&D database using stringent inclusion and exclusion criteria to arrive at the Antiviral Clinical Development Landscape. The database was licensed from Airfinity, a predictive health intelligence and data analytics firm, who monitors preclinical and clinical development of antivirals against 12 viral families that pose the greatest risk of pandemic potential. As of November 16, 2023, the Airfinity database identified 687 diverse compound/indications for the 12 priority viral families of pandemic potential; 387 were preclinical and 300 were in the clinical phase of development and/or approved by a global regulatory authority.

The triage, using inclusion and exclusion criteria, of the clinical phase and approved compound/indications identified 61 distinct antiviral compounds associated with 80 compound/indications, as reported above. Consistent with INTREPID's mission of advancing small molecule antiviral development, compounds excluded from our analysis were antibodies, antibiotics and other anti-infectives, cell-based therapy, HIV or HCV-specific antivirals, host targets (including immunomodulators), natural products/nutraceuticals/herbals and vaccines. The triage of clinical phase compounds included small molecules, peptides, and RNA-based compounds with known direct antiviral mechanisms of action, in vitro/in vivo activity, first-in-human (FIH) single ascending dose vs. multiple ascending dose data completed and no major safety signals observed.

ABOUT THE INTREPID ALLIANCE

The INTREPID Alliance has been formed to facilitate and 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 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 INTREPID Alliance: Antiviral Clinical Development Landscape. 24 January 2024.
³ World Health Organization priority disease areas. Accessed 24 January 2024.

Source: INTREPID Alliance