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Continuous Manufacturing Process for Human Use Helminth Infection Treatment

Award type :
Product Development Award
Product type :
Therapeutics
Award year :
2023
Project start date :
11 / 03 / 2023
Project end date :
10 / 30 / 2025
Project duration (months) :
23
Development stage :
Phase 2, Phase 3
Target disease :
Helminth infections (onchocerciasis)
Region served :
World
Recipient organization / Country of funding recipient organization :
Drugs for Neglected Diseases initiative (DNDi) / Switzerland
Collaborator(s) / Country :
Kolon Life Science / Republic of Korea
Funding amount(KRW) :
1,206,444,300

A low-cost, scalable manufacturing process for oxfendazole, a treatment for helminth infections including onchocerciasis, was developed using green chemistry principles and continuous flow technology. A non-GMP demonstration batch of oxfendazole API was produced with 99.3% purity, confirming process scalability. Further work on tablet formulation and process development is underway in preparation for future Phase 2, 3 trials.