NEW DELHI: With the aim to provide affordable dengue treatment globally, the Serum Institute of India (SII) and the non-profit medical research organisation Drugs for Neglected Diseases initiative (DNDi) have signed a licensing agreement covering clinical testing and future access to all the Pune-based pharma firm's developed monoclonal antibody treatment against dengue.
With this agreement finalised, a Phase III clinical trial led by DNDi is expected to begin in the first quarter of 2027 across Malaysia, Thailand, and Brazil, all home to leading public health institutions that are members of the Dengue Alliance, a global partnership of dengue-endemic countries working to develop effective and accessible treatments.
Around 1,000 participants are expected to join the study across the three countries.
Monoclonal antibodies are currently among the most advanced dengue treatment candidates.
SII has developed and optimised the current formulation of its treatment and conducted pre-clinical studies and Phase I and II clinical trials that delivered promising safety and efficacy results.
It is currently leading a pivotal Phase III clinical trial in India.
Despite dengue’s rapid global spread and increasingly frequent outbreaks, there is still no specific treatment.
Patient management remains purely symptomatic, requiring intensive care - including close monitoring and administration of intravenous fluids - that can lead to health systems becoming quickly overwhelmed during outbreaks.
Children under 15 years of age are at higher risk of developing severe dengue, a mosquito-borne disease. Pregnant women with dengue face increased risk of maternal mortality and pregnancy loss.
For the Phase III trial conducted by DNDi in Malaysia, Thailand and Brazil, SII will supply study medicines and manage their refrigerated transportation to clinical trial sites.
“Serum Institute of India is committed to go all out in controlling dengue. We are working on both preventive and therapeutic applications to protect populations in dengue-endemic areas. Going by our philosophy, we will make all attempts to develop, produce, and distribute the vaccine and monoclonal antibodies all over the globe in an affordable manner, together with our committed partners, the Indian Council of Medical Research (ICMR) and DNDi. We are delighted and privileged to collaborate with DNDi to continue the development of our monoclonal antibody in the Dengue Alliance countries," said Dr Rajeev Dhere, Senior Scientific Advisor at SII.
Led by DNDi, the trial in Malaysia, Thailand, and Brazil will be conducted with financial support from the European Commission’s Directorate-General for Health Emergency Preparedness and Response Authority (DG HERA) in partnership with the French Development Agency (AFD).
Last November, DG HERA announced it will invest EUR 20 million to advance the development of two new dengue medicines.
"Treatments will be essential to tackling dengue. We need therapeutics that can prevent progression to the severe stage of the disease to save lives and reduce economic strain, not only on patients but also on public health systems. Treatments are particularly needed for vulnerable groups, including children, pregnant women, and older people, who face a higher risk of severe and potentially fatal dengue," said Dr André Siqueira, Head of Dengue at DNDi.
Dengue is one of the fastest-growing mosquito-borne viral infections, with 5.6 billion people at risk. The disease was once limited to tropical countries. Fuelled by climate change and globalisation, dengue is expanding to many other parts of the world, including Europe.
Current efforts to control dengue focus mainly on reducing the transmission by Aedes mosquitoes that carry the virus, and on deploying vaccines developed in recent years.
However, vaccine coverage remains low, and their effectiveness varies depending on prior exposure and virus serotype. Treatments are therefore an essential addition to the arsenal of health tools required to tackle the disease.
In low-and middle-income countries (LMICs), the product will be made available at the lowest sustainable price needed to support access while preserving reliable supply.
In Europe, the product will be offered on an affordable basis in agreement with relevant authorities to ensure timely and equitable access while supporting long-term sustainability. The partnership will prioritise supply through the public sector in all countries.
The clinical study will be implemented in close collaboration with Dengue Alliance partners: the Oswaldo Cruz Foundation (Fiocruz) and the Universidade Federal de Minas Gerais in Brazil; the Faculty of Medicine, Siriraj Hospital, Mahidol University in Thailand; and the Ministry of Health in Malaysia.
The Dengue Alliance currently includes research institutions from Brazil, India, Malaysia, and Thailand, all countries with longstanding high burdens of dengue that have each recorded between roughly 100,000 and 10 million cases annually over recent years.
The Alliance was founded on the principle that South-South cooperation among endemic countries is an effective and proven model for developing and delivering new medicines to the populations that need them most.
DNDi and its partners in the Dengue Alliance aim to advance several promising medicines into clinical trials, including antivirals that directly target the virus, host‑directed therapies that support the human immune response to the infection, and monoclonal antibodies.
Monoclonal antibodies are laboratory‑engineered proteins designed to mimic the body’s natural antibodies by targeting the dengue virus. The Alliance is continuously exploring potential new treatments to be developed, including existing drugs that could be repurposed and new chemical entities.
In India, DNDi works with the Indian Council of Medical Research (ICMR), one of DNDi’s founding partners, to support the government’s goal of eliminating visceral leishmaniasis through clinical research, capacity building, and last-mile support. DNDi has also implemented projects in Bangladesh and Nepal and is expanding its work to develop new tools for lymphatic filariasis, dengue, and mycetoma. dndi.org
According to Florika Fink-Hooijer, Director-General of the European Commission’s Health Emergency Preparedness and Response Authority - DG HERA,"More than half of the world's population now lives in areas at risk of dengue infection, and what was once considered a disease confined to tropical regions is increasingly affecting Europe."
"Yet, despite the growing global burden of dengue, there is still no specific antiviral treatment. The European Commission, through DG HERA, is supporting the late-stage clinical development of a promising monoclonal antibody that has the potential to become the first targeted therapeutic for dengue. This landmark clinical trial, which will also include vulnerable populations such as children, pregnant women and older adults, represents an important step towards expanding access to effective medical countermeasures where they are most needed. By investing in innovation and global partnerships, we are strengthening preparedness against the growing threat of vector-borne diseases and improving our ability to protect populations in Europe and around the world.
