Serum Institute of India gets CDSCO Panel nod to study Dengue Monoclonal Antibody
New Delhi: Serum Institute of India has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of dengue monoclonal antibody in children ≥ 5 years and adults with dengue.
This came after Serum Institute of India presented the proposal to conduct a Phase III clinical trial titled “A Phase III, double-blind, randomized, placebo-controlled, multicentric study of dengue monoclonal antibody in children ≥ 5 years and adults with dengue” via protocol number: Dengue-mAb-03version 1.0, dated 04 Jul 2024 along with the results of the Phase II study.
The Serum Institute of India (SII) is developing a dengue monoclonal antibody drug called Dengushield, which is an antiviral and orphan drug.
Dengue monoclonal antibody is an engineered humanised monoclonal antibody that binds to a non-immunodominant epitope on domain III of the envelope protein (EDIII) and has shown potent, specific neutralisation of all four serotypes of dengue virus.
At the recent SEC meeting for Antimicrobial and Antiviral held on 19th September 2024, the expert panel reviewed the proposal presented by the drug major Serum Institute to conduct the Phase III clinical trial of the antimicrobial drug Dengue Monoclonal Antibody (Recombinant Dengue mAb).
The committee reviewed the results of the Phase II study.
After detailed deliberation, the committee recommended a grant of permission to conduct the Phase III clinical trial as per the protocol presented by the firm.
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