Kolon Life Science announced on the 21st that it has signed an agreement with the international non-profit organization Drugs for Neglected Diseases initiative (DNDi) to develop a low-cost, sustainable process for a candidate drug for the treatment of onchocerciasis, a neglected tropical disease.
Onchocerciasis is transmitted by blackflies near rivers. It is a dangerous disease that can cause severe itching, vision impairment, or complete blindness upon infection. With 19 million patients, it is considered the second leading infectious cause of blindness worldwide. Considering that most patients are from low- to middle-income populations in tropical regions, reducing the costs involved in new drug development and production is crucial.
Kolon Life Science will take on the role of developing a process capable of mass-producing high-quality Oxfendazole, which is currently used as an anthelmintic for animals, at a level suitable for human use. Over the next two years, the company plans to develop the entire manufacturing process for high-purity Oxfendazole and reduce production costs to a level accessible for low- and middle-income countries. They will conduct crystallization research and continuous process development together and supply the raw materials necessary for future clinical trials and commercialization of the new drug.
DNDi aims to complete Phase 2a clinical trials by 2026 and Phase 2b/3 trials by 2030, following the completion of Phase 1 trials in Tanzania last year. In addition to river blindness, DNDi plans to evaluate Oxfendazole for other diseases such as soil-transmitted helminthiasis, mansonellosis, and rhodesiense sleeping sickness. DNDi is a non-profit international organization established in 2003 in Geneva, Switzerland, by M?decins Sans Fronti?res (MSF), the world's largest medical humanitarian organization. It has been dedicated to combating neglected tropical diseases such as malaria, leishmaniasis, sleeping sickness, Chagas disease, and onchocerciasis. DNDi is advancing the development of over 20 new drug pipelines in collaboration with more than 200 companies worldwide, including multinational pharmaceutical companies.
This agreement receives product development research funding support from the Light Foundation, established through contributions from the Ministry of Health and Welfare, the Bill & Melinda Gates Foundation, and domestic pharmaceutical and bio companies, aiming to improve health equity in infectious diseases in low- and middle-income countries. The Light Foundation promotes multilateral cooperation and participation of end-users and has selected and supported research projects on 15 infectious diseases, including respiratory infections and neglected tropical diseases.
Kim Seon-jin, CEO of Kolon Life Science, said, "This agreement was made to fulfill one of Kolon Group's core missions of corporate social responsibility and to support the global expansion of Kolon Life Science's synthetic clinical new drug contract development and manufacturing organization (CDMO) business." He added, "We hope this agreement will bear fruit and help marginalized populations worldwide suffering from vision impairment and the risk of blindness."
Laurent Fraisse, DNDi Director of Research and Development, also said, "We are pleased to carry out this project with Kolon Life Science with the support of the Light Foundation, and we expect Kolon Life Science's expertise and know-how to contribute to the development and optimization of the Oxfendazole production process." He added, "With 240 million people worldwide, mainly marginalized populations, exposed to the risk of river blindness, developing an affordable treatment will be key to managing this dangerous disease."
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