March 5, 2015
The Global Health Investment Fund (GHIF) has committed US$ 10 million to support completing the dossier for the registration of moxidectin for the treatment of onchocerciasis. Medicines Development for Global Health (MDGH), an Australian not-for-profit biopharmaceutical company, will be managing the work.
Onchocerciasis, also known as river blindness, is a debilitating parasitic infection. Mapping conducted under the leadership of the African Programme for Onchocerciasis Control (APOC) has identified more than 63 million people in Central and East Africa at risk. The disease is caused by the filarial worm Onchocerca volvulus, which is transmitted through the bites of infected blackflies of the species Simulium. It causes severe itching and skin disfigurement and can lead to blindness.
Moxidectin is a second-generation veterinary anthelmintic with activity against a broad range of parasitic worms and insects. TDR has worked extensively with academic groups, industry, onchocerciasis endemic countries and communities and investigators in these countries to evaluate the utility of moxidectin for the control and potential elimination of onchocerciasis since the early 1990s. The Phase III study is completed and the data suggest that moxidectin is efficacious and has a safety profile consistent with mass drug administration.
“We are delighted to see that the development of moxidectin for onchocerciasis control will be completed,” said John Reeder, Director of TDR. “Our vision for this drug being registered and made available to the onchocerciasis endemic countries has taken another important step forward.”
The GHIF investment will be used to support the manufacture of moxidectin and the compilation of the regulatory dossier required for the registration process for use in humans. Should the drug be approved, MDGH will work towards ensuring a secure supply of moxidectin for onchocerciasis and, with GHIF, continue to research other potential human uses of moxidectin for infectious diseases.
Control of the disease currently relies on mass drug administration with ivermectin (Mectizan®), the only drug currently in use. TDR also contributed to this development and led the studies that resulted in ‘community-directed distribution’ of ivermectin, which was implemented in virtually all endemic areas by APOC.
Moxidectin may interrupt parasite transmission faster than ivermectin, thus reducing the number of years mass treatment programmes have to be sustained. “Moxidectin has the potential to be a very important new medicine for controlling river blindness, and we are delighted to work with GHIF to achieve the goal of registering this drug for human use,” said Mark Sullivan CEO of Medicines Development. “GHIF’s strategy to invest in projects that impact health, particularly in low- and middle-income countries, could not be better matched with the reasons we established Medicines Development.”
Julia Fan Li of the GHIF says, “This will hopefully give health workers a new tool in their armoury to complete, what we hope will be the final push to not only control, but to eliminate onchocerciasis forever.”
The GHIF is a private investment fund structured by JPMorgan Chase & Co. and the Bill & Melinda Gates Foundation, which received anchor investments from Grand Challenges Canada (funded by the Government of Canada), the German Ministry for Economic Cooperation and Development (acting through KfW) and the Children’s Investment Fund Foundation. The GHIF’s mission is to finance late-stage drugs, vaccines and diagnostics for diseases that disproportionately burden low-income populations.