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Novel Antibiotic Combinations to Address AMR Burden in Neonatal Sepsis

Award type :
Product Development Award
Product type :
Therapeutics
Award year :
2023
Project start date :
11 / 01 / 2023
Project end date :
09 / 30 / 2026
Project duration (months) :
36
Development stage :
Phase 3
Target disease :
Neonatal sepsis
Region served :
World
Recipient organization / Country of funding recipient organization :
GARDP Foundation / Switzerland
Collaborator(s) / Country :
Jeil Pharmaceutical / Republic of Korea
Funding amount(KRW) :
4,000,000,000

This project uses an innovative approach to identify and evaluate the safety and effectiveness of novel combinations of three existing antibiotics (flomoxef, fosfomycin, and amikacin), which are licensed for neonates. The use of these drugs will be compared against existing recommended and commonly used regimens in their ability to reduce mortality due to neonatal sepsis. This grant includes cost-effective Active Pharmaceutical Ingredient manufacturing processes and strengthening manufacturing capacity for flomoxef. Additionally, the project aims to advance access to flomoxef, including WHO prequalification and direct national registration routes. This project not only addresses the critical issue of AMR but also represents a significant advancement in the fight against neonatal sepsis by providing improved and new treatment recommendations across diverse settings.