The Pune-based Serum Institute of India (SII) has partnered with Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development organisation, to accelerate the clinical development of a monoclonal antibody (mab) treatment for dengue that will be affordable and accessible in low- and middle-income countries (LMICs).
Mab are lab-produced antibodies, meant to mimic the ones naturally produced within the body to neutralise infectious agents, for instance viral particles.
SII has already conducted pre-clinical studies and Phase I and II clinical trials of a potential candidate drug for dengue. This January, an expert committee of India’s Central Drugs Standards Control Organisation (CDSCO) recommended that SII submit safety and efficacy data regarding the mab in a larger number of patients from phase III studies before recommending manufacturing and marketing approval for its dengue drug for adults.
“Through this collaboration, both SII and DNDi will develop a work plan to implement R&D, additional Phase III clinical trials along with a joint strategy to raise necessary funds and resources. Additionally, a joint project team will be formed to advance clinical trials, with the goal of registering and deploying the dengue monoclonal antibody in India and other dengue-endemic countries, provided the studies confirm its safety and efficacy,” a statement from DNDi noted.
Testing in Brazil
This could mean testing the treatment in Brazil and selected countries in south-east Asia.
“This collaboration with DNDi will be instrumental in advancing clinical development of a dengue monoclonal antibody in Brazil and potentially other endemic countries in Southeast Asia, with a focus on making treatment affordable and accessible,” Dr. Prasad Kulkarni, Executive Director, SII, said in a statement. “We look forward to the positive impact this effort will have in reducing the burden of dengue and saving lives in vulnerable communities,” he said.
“India reports tens of thousands of dengue cases every year, with outbreaks occurring every two to three years in different states,” Dr. Kavita Singh, Asia Continental Lead & Director South Asia, DNDi, said in a statement. “What is deeply concerning is that dengue is no longer confined to historically endemic regions but is rapidly expanding into newer states. Addressing this growing threat demands a multi-pronged approach, including strengthened vector control, surveillance, community awareness and, critically, the development of effective treatments and diagnostics,” she said.
Dengue poses a significant threat, with 3.9 billion people at risk and cases more than doubling each year since 2021. It is also spreading to non-endemic areas due to climate change and urbanisation. Despite its prevalence and severity, there is still no specific treatment available for dengue. Medicines that could prevent mild cases from becoming severe would therefore play an important role in reducing mortality and preventing hospitals from being overwhelmed during outbreaks.
Published – June 14, 2025 01:19 am IST
