SII, DNDi collaborate on new Dengue treatment for low, middle income countries

With this collaboration, both SII and DNDi will develop a work plan to implement R&D, additional Phase III clinical trials, and access activities, along with a joint strategy to raise the 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. .

"Dengue is a rapidly spreading, climate-sensitive disease for which medicines are urgently needed. We are proud to partner with Serum Institute of India to advance the development of an affordable monoclonal antibody treatment. This partnership brings together complementary strengths to ensure that people most at risk, particularly in dengue-endemic countries, have timely and equitable access to life-saving treatment," said Dr André Siqueira, Head of Dengue at DNDi.

"India reports tens of thousands of dengue cases every year, with outbreaks occurring every two to three years in different states. What is deeply concerning is how 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, from strengthened vector control, surveillance, community awareness and, critically, the development of effective treatment and diagnostics options. DNDi’s partnership with Serum Institute of India is a significant step forward in this direction". Dr Kavita Singh, Asia Continental Lead & Director South Asia, DNDi.

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,"said Dr. Prasad Kulkarni, Executive Director, Serum Institute of India. "We look forward to the positive impact this effort will have in reducing the burden of dengue and saving lives in vulnerable communities."

SII has already conducted preclinical studies, Phase 1 and Phase 2 clinical studies that show the candidate (earlier called VIS513) is safe and effective.

Now SII and DNDi are coming together to conduct additional Phase 3 trials in other dengue endemic countries like Brazil.

DNDi will act as the lead partner for these Phase III clinical trials including leadership, sponsorship, and implementation in Brazil and potentially other endemic countries in Southeast Asia. DNDi and SII will lead strategic engagement efforts with the Dengue Alliance, relevant industry stakeholders, and policymakers in low- and middle-income countries.

For the DNDi led trial in Brazil or other countries, SII will provide the development background and technical support. Furthermore, SII will also be responsible for manufacturing, development and providing clinical supplies of monoclonal antibodies. The company will be defining and executing the regulatory strategy in India and will lead the commercialization of the product in the country.

Launched in 2022, the Dengue Alliance is a global partnership led by institutions from dengue-endemic countries and DNDi that aims to develop affordable and accessible treatments for dengue. The organization will also contribute to the regulatory and commercialization strategy in LMICs and will lead policy and advocacy activities to advance equitable access.

Dengue poses a significant threat with 3.9 billion people at risk and cases are more than doubling since 2021, as it propagates to non-endemic areas due to climate change and urbanization. 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 to reduce mortality and prevent hospitals from being overwhelmed during outbreaks.