Latest news with #PrasadKulkarni
The Hindu
a day ago
- Health
- The Hindu
SII, DNDi partner for expanding human trials for dengue treatment
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.
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Business Standard
a day ago
- Health
- Business Standard
Serum Institute signs MoU with DNDi to develop dengue treatment candidate
Serum Institute of India (SII) on Friday signed a memorandum of understanding (MoU) with medical research organisation Drugs for Neglected Diseases initiative (DNDi) to accelerate clinical development of a monoclonal antibody treatment for dengue that will be affordable and accessible in low- and middle-income countries (LMICs). As part of the collaboration, both SII and DNDi will develop a work plan to implement research and development, Phase 3 clinical trials, and access activities, along with a joint strategy to raise the necessary funds and resources. SII stated that it has already conducted pre-clinical studies and Phase 1 and 2 clinical trials that show the candidate (formerly VIS513) is safe and effective. It is currently leading the Phase 3 clinical trial in India for licensure. SII and DNDi will now work together to conduct additional Phase 3 trials in other dengue-endemic countries as well, such as Brazil. The Pune-based company added that 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 countries, provided the studies confirm its safety and efficacy. Commenting on the partnership, Prasad Kulkarni, executive director at SII, said that the 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. DNDi will act as the lead partner for these clinical trials, including trial leadership, sponsorship, and implementation in Brazil and potentially other endemic countries in Southeast Asia. 'Both participants will also lead strategic engagement efforts with the Dengue Alliance, relevant industry stakeholders, and policymakers in LMICs,' they added. Kavita Singh, Asia Continental Lead and Director – South Asia at DNDi, said that India reports tens of thousands of dengue cases every year, with outbreaks occurring every two to three years in different states. 'Addressing the growing threat demands a multi-pronged approach, including strengthened vector control, surveillance, community awareness and the development of effective treatments and diagnostics,' she added.
United News of India
a day ago
- Health
- United News of India
SII, DNDi in pact to develop affordable dengue treatment
New Delhi, June 13 (UNI) The Serum Institute of India (SII), the world's largest vaccine manufacturer and Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research entity, have entered into a partnership with an aim to accelerate the development of a monoclonal antibody treatment for dengue fever. The initiative specifically targets low- and middle-income countries (LMICs), where dengue is endemic and health systems are often under strain during outbreaks, said a joint statement here from the organisations. Despite the rising global burden of dengue — with an estimated 3.9 billion people at risk and cases more than doubling annually since 2021 — there is currently no specific treatment available. The new monoclonal antibody candidate, previously known as VIS513, has shown promise in pre-clinical studies and early-phase clinical trials led by SII, demonstrating safety and efficacy, added the statement. The SII is currently leading a pivotal Phase III clinical trial in India, while SII and DNDi will now work together to conduct additional Phase III trials in other dengue-endemic countries, including Brazil, Malaysia and Thailand, it added. The two entities will work jointly to implement research and development activities, raise necessary resources, and build strategies for regulatory approval and equitable access. Dr Kavita Singh, Director of South Asia and Asia Continental Lead at DNDi, noted, 'Dengue is no longer confined to historically endemic areas. Its spread into newer regions makes it imperative to invest in both preventive and therapeutic solutions' She said climate change is altering patterns for dengue fever and other diseases. "Before, we didn't have as many cases, or as many deaths,' she added. Dr Prasad Kulkarni, executive director of SII, was of the opinion that this move would help advancing the clinical development of a dengue monoclonal antibody not only in India, but also in Brazil and other countries in Southeast Asia. Our aim is to make this treatment affordable and widely accessible.' Since the start of 2025, more than 3 million dengue cases and over 1,400 dengue-related deaths have been reported across 90 countries in the WHO Regions of the America, South-East Asia, the Western Pacific, Eastern Mediterranean, and Africa.
