The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced on Thursday the publication of new data in the journal Nature showing that an early-stage clinical candidate (JNJ-1802) provides strong protection against dengue in non-human primates and mice.
According to the pharmaceutical major, the antiviral, which was shown to be safe and well tolerated in Phase 1 first-in-human clinical study, is now progressing into Phase 2 clinical studies for the prevention and treatment of dengue.
“The new data indicate JNJ-1802 is effective against all four of the dengue serotypes in mouse models and provides strong protection against two tested serotypes (DENV-1 and -2) in non-human primates. These findings build on research published in Nature in 2021 that first identified the novel mechanism of action from the same chemical series as JNJ-1802. The mechanism of action prevents the interaction between two viral proteins (NS3 and NS4B), thereby stopping the ability of the virus to replicate. A similar mechanism of action was confirmed for JNJ-1802 with these new data,” the company stated on Thursday.
This new research, together with Phase 1 first-in-human data showing the compound to be safe and well-tolerated, is supportive of further clinical development of JNJ-1802 for both prophylaxis and treatment of dengue, the company stated.
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“The unprecedented rise in dengue outbreaks throughout the past years offers a glimpse of what lies ahead as climate change continues to put more people and communities at risk of dengue. We know an antiviral will be critical to addressing the unmet needs today and tomorrow, and we are committed to developing our breakthrough compound to expand the toolset available to prevent and treat dengue,” said Ruxandra Draghia-Akli, M.D., Ph.D., Global Head, Global Public Health R&D at Janssen Research & Development, LLC in a statement.
Janssen’s research and development of its dengue compound, included the KU Leuven Rega Institute, the KU Leuven Centre for Drug Design and Discovery (CD3), Department of Virology at the Biomedical Primate Research Centre, Department of Infectious Diseases at Heidelberg University, Sealy Institute for Vaccine Sciences at the University of Texas Medical Branch Health (UTMB), Unité des Virus Émergents at Aix-Marseille University and the Walter Reed Army Institute of Research.
As many as 400 million people contract the dengue virus each year, and the resulting illness is one of the leading causes of hospitalization among children in countries in Latin America and Asia. Despite the global burden of dengue, and the fact that reinfection is possible due to the presence of four dengue serotypes, there are no therapeutics available to treat the disease and only a limited number of prevention options have been approved.
“The promising results of JNJ-1802 to date offer the hope that science will be able to deliver against this threat as more and more communities are impacted worldwide. Dengue requires global action and we are proud to collaborate alongside partners here in Europe and around the world in advancing the development of this compound to its next phase,” said Marnix Van Loock, Ph.D., Lead for Emerging Pathogens, Global Public Health R&D at Janssen Pharmaceutica NV in a statement.
The dengue challenge is likely to grow in the coming years. In 2022, countries like Singapore, Nepal and Bangladesh experienced some of their worst outbreaks on record, while non-endemic countries like France and the United States reported some of their first, locally-acquired cases, part of a broader trend of increasing zoonotic outbreaks linked to climate change.
In 2022, the Company joined the global community to endorse the Kigali Declaration on Neglected Tropical Diseases, pledging to continue to donate up to 200 million doses annually of mebendazole through 2025 to tackle intestinal worms and advance novel R&D programs to discover new medications needed to beat leprosy and dengue.
In addition to developing JNJ-1802, Johnson & Johnson is working to holistically strengthen R&D for dengue, including through novel R&D approaches and leveraging emerging technology, it added.