Johnson & Johnson's dengue antiviral drug shows positive results

Around November, the ICMR sought the drug regulator's nod for phase-3 trials of a vaccine candidate it developed with drugmakers SII and Panacea Biotec

Novel anti-viral drug developed by Johnson & Johnson (J&J) arm Janssen Pharmaceutical provides “strong protection” against dengue in non-human primates and mice, early stage clinical data published in ‘Nature’ journal has revealed.

“The first-in-class antiviral, which was shown to be safe and well tolerated in a phase 1 first-in-human clinical study, is progressing into Phase 2 clinical studies for the prevention and treatment of dengue,” the company said on Thursday.

The new data indicated that the investigational candidate JNJ-1802 is effective against all four of the dengue serotypes in mice and provides strong protection against two tested serotypes in non-human primates.

Marnix Van Loock, lead for emerging pathogens, global public health R&D at Janssen Pharmaceutica NV, said, “Dengue requires global action and we are proud to collaborate alongside partners in Europe and around the world in advancing the development of this compound to its next phase.”

Last December, Takeda’s tetravalent dengue vaccine Qdenga got marketing authorisation in the EU. The Japanese major has said it was already in talks with the Indian government to bring its dengue vaccine to this country.

Around November, the country’s apex medical research organisation, the Indian Council of Medical Research (ICMR), sought the drug regulator’s nod for phase-3 trials of a vaccine candidate it developed with drugmakers Serum Institute of India (SII) and Panacea Biotec. Another DNA vaccine candidate for dengue developed by scientists from the National Centre for Biological Sciences (NCBS), Bengaluru, in collaboration with nine institutions in India, Africa and the US, has also shown a robust immune response and improved survival rates after exposure to the disease.

As many as 400 million people are affected by dengue each year, and the resulting illness is one of the leading causes of hospitalisation among children in countries in Latin America and Asia. In 2021, India reported 110,473 dengue cases, ranking fourth among the worst-affected nations.

“The unprecedented rise in dengue outbreaks in the (recent) past offers a glimpse of what lies ahead as climate change continues to put more people and communities at risk of dengue,” said Ruxandra Draghia-Akli, global head, global public health R&D at Janssen Research & Development, LLC.

“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.”

The dengue menace is likely to grow in the coming years. In 2022, countries such as Singapore, Nepal, and Bangladesh experienced some of their worst outbreaks on record, while non-endemic countries like France and the US reported some of their first, locally acquired cases, part of a broader trend of increasing zoonotic outbreaks linked to climate change.

In addition to developing JNJ-1802, Johnson & Johnson is using artificial intelligence (AI) to forecast dengue hotspots and build predictive models for dengue incidence to accelerate trial recruitment and site sourcing.

Janssen has been working with strategic partners in the research and development of its dengue compound, including 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.