First participant enrolled in a Phase 3 clinical trial of moxidectin for lymphatic filariasis and other neglected tropical diseases in Fiji

Medicines Development for Global Health (MDGH) today announced the enrolment of the first participant in a large clinical trial evaluating a new treatment approach for lymphatic filariasis (LF) and other neglected tropical diseases (NTDs) in Fiji.

The Phase 3 study, conducted in partnership with the Fiji Ministry of Health and Medical Services (MHMS), will assess the safety, efficacy, and acceptability of moxidectin-based mass drug administration compared to the current standard treatment. The trial will be conducted in communities across the islands of Rotuma and Taveuni and is expected to include more than 5,000 participants.

Lymphatic filariasis is a mosquito-borne parasitic disease that can lead to long-term disability, including lymphoedema and hydrocoele. While significant progress has been made globally, challenges remain in some regions, including parts of the Pacific.

Moxidectin, the investigational medicine being evaluated in the study, has a longer duration of action than ivermectin, the current cornerstone of treatment. Researchers hope that this may offer an alternate treatment option in settings where existing approaches have had limited impact. The study also aims to assess the broader impact of treatment on other neglected tropical diseases, including scabies and strongyloidiasis, reflecting growing global interest in integrated approaches to disease control.

“This is an important milestone, both for the study and for efforts to eliminate lymphatic filariasis as a public health problem in the Pacific region and beyond,” said Sally Kinrade, Moxidectin for onchocerciasis and lymphatic filariasis Project Lead. “We are proud to be working in partnership with communities and health authorities in Fiji to generate evidence that could help strengthen disease control programs.”

The trial is being conducted in partnership with the Fiji MHMS, Murdoch Children's Research Institute, the Kirby Institute UNSW, and Bruyere Health Research Institute.

Funding for the study is provided by the Australian Department of Foreign Affairs and Trade through the Partnerships for a Healthy Region initiative.

“The BOLT study is directly in line with the Ministry’s Strategic Plan, Priority 1 – To Strengthen Public Health and Primary Health Care,” said Dr Luisa Cikamatana, Acting Permenent Secretary of Health, Fiji Ministry of Health and Medical Services. “The main goal here is to find ways to identify how we can address Fiji’s challenge in controlling diseases like Lymphatic Filariasis (waqaqa), commonly referred to as Elephantiasis, as well as Scabies (milamila / karokaro) and intestinal worms (ukomu). This study will help us to learn how to control and prevent complications and the on-going infections of these diseases in islands like Rotuma and Taveuni. This study has Ministry endorsement and I encourage members of the community to participate.”

The study is expected to runover two years, with results expected to contribute to the global evidence base on moxidectin for NTDs and inform future policy decisions.

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About Medicines Development for Global Health

MDGH is a not-for-profit pharmaceutical company dedicated to the development and supply of new and improved medicines for diseases that disproportionately affect people in low- and middle-income countries.

In 2014, MDGH received a license from WHO (which had initiated and led moxidectin development for onchocerciasis through TDR), for all data at its disposal to support the registration of moxidectin and make it available to endemic countries. In 2018, MDGH achieved United States Food and Drug Administration approval of moxidectin for the treatment of river blindness (onchocerciasis), and is currently developing moxidectin for the treatment of several other neglected tropical diseases.

In 2020, the company assumed full responsibility for the development and commercialisation of dovramilast from Amgen for both tuberculosis and leprosy type 2 reaction.

Further information is available at www.medicinesdevelopment.com

Media Contact

Molly Kennedy

Principal Development Manager, Lymphatic Filariasis

+61 3 9912 2400

news@MDGH.com

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