The Korean global health R&D funding agency RIGHT Fund, the Korean biotech company ST Pharm, and the international non-profit medical research organization Drugs for Neglected Disease initiative (DNDi) announced a partnership to find cost-effective ways to manufacture a promising drug for visceral leishmaniasis, one of the world’s most neglected diseases.
‘We will apply cutting-edge technology and the process chemistry expertise of ST Pharm to optimize the manufacturing process for our visceral leishmaniasis drug candidate, in the hope of making a future treatment that is affordable and accessible to the millions of people at risk across the globe,’ said Dr Stephen Robinson, Pharmaceutical Development Director at DNDi. ‘We are very excited to start this partnership in Korea.’
Transmitted by the bite of sandflies, visceral leishmaniasis is the deadliest parasitic killer after malaria. The neglected disease impacts the most vulnerable communities, particularly people affected by malnutrition, poverty, displacement, and climate and environmental change. It attacks the immune system and is fatal if left untreated. Between 50,000 and 90,000 people are infected every year.
Even though 600 million people are at risk of visceral leishmaniasis worldwide, particularly in East Africa, India, and Latin America, there is still a lack of appropriate treatments. Existing drugs have serious drawbacks in terms of safety and cost, are difficult to administer in resource-limited settings, and can require prolonged hospitalization.
DNDi, a non-profit medical R&D organization founded in 2003 by Médecins Sans Frontières (MSF), the World Health Organization, and five leading international research institutes, is therefore developing a promising compound that aims for superior efficacy and safety in patients. The compound is currently being investigated in Phase I clinical trials. However, the current manufacturing process for the active pharmaceutical ingredient (API) requires optimization before commercial scale-up to ensure the treatment will be affordable.
‘We are thrilled about this important partnership to demonstrate that this much-needed drug can be manufactured at a more affordable cost and give hope to the millions of people at risk of this horrendous disease,’ said Dr Choi Jun Young, Vice-President and Head of Research & Development at ST Pharm. ‘Visceral leishmaniasis affects the poorest of the poor and disproportionally affects children. We are happy that our breakthrough technologies may ultimately benefit these very neglected patients.’
ST Pharm will evaluate alternative processes to manufacture the API and optimize its production by reducing the number of processing steps. The company will also explore the use of its innovative continuous flow technology to improve the yield and purity of the API – as well as minimize waste in production, making the manufacturing process more environmentally friendly.
‘Neglected diseases such as visceral leishmaniasis reinforce a vicious cycle of poverty. A safe, efficacious, and more affordable drug could have a huge impact in terms of improving patients’ access to treatment and decreasing transmission. It would therefore also play an important role in reducing health inequities experienced by people in the most affected regions,’ said Kim Hani, Executive Director of the Research Investment for Global Health Technology Fund (RIGHT Fund), which is funding the research.
The RIGHT Fund, established in July 2018, is the first funding agency in Korea to support global health research and development thought public-private partnerships. It finances projects addressing urgent medical needs of low- and middle-income countries.
This project will be conducted over a one-year period. If successful, DNDi and ST Pharm plan to conduct further process development and pilot the production of API for Phase III clinical trials.
A not-for-profit research and development organization, DNDi works to deliver new treatments for neglected patients, those living with Chagas disease, sleeping sickness (human African trypanosomiasis), leishmaniasis, filarial infections, mycetoma, paediatric HIV, hepatitis C, and dengue. DNDi is also coordinating the ANTICOV clinical trial to find treatments for mild-to-moderate COVID-19 cases in low-resource settings. Since its inception in 2003, DNDi has delivered twelve new treatments to date, including new drug combinations for kala-azar, two fixed-dose antimalarials, and DNDi’s first successfully developed new chemical entity, fexinidazole, approved in 2018 for the treatment of both stages of sleeping sickness. dndi.org
About the RIGHT Fund
The Research Investment for Global Health Technology Fund, established in July of 2018, is the first funding agency dedicated to supporting global health R&D via 3-way partnerships between the Government of Korea, Korean life science companies, and international funders. The RIGHT Fund provides a platform for both the Government of Korea and Korean industry to increase their contribution to global health and will serve as a vehicle for investment in R&D projects aimed at delivering tangible outcomes to address the burden of disease in low- and middle-income countries. rightfund.org
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Photo credit: Vinicius Berger – DNDi