New Delhi, Jun 13 (PTI) Serum Institute of India on Friday said it has tied up with Drugs for Neglected Diseases initiative (DNDi)to accelerate the clinical development of a monoclonal antibody treatment for dengue that will be affordable and accessible in low and middle-income countries.
As part of the 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 necessary funds and resources, the Pune-based vaccine maker said in a statement.
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, it added.
"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," Serum Institute of India (SII) Executive Director Prasad Kulkarni said.
SII has already conducted pre-clinical studies and Phase I and II clinical trials that show the candidate (formerly VIS513) is safe and effective.
Currently, SII is leading the pivotal Phase III clinical trials in India for licensure.
SII and DNDi will now work together to conduct additional Phase III trials in other dengue-endemic countries, including Brazil.
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