We turn the idea into a medicine.
Moxidectin is an experimental medicine in development for the treatment of river blindness (onchocerciasis) and scabies. The potential for moxidectin as a treatment of soil-transmitted helminths, Strongyloides, and lymphatic filariasis is also being evaluated. These neglected tropical diseases affect over 1 billion of the world’s most disadvantaged people.
Onchocerciasis is a disease caused by the worm Onchocerca volvulus, which is transmitted by Simulium black flies that breed in fast-flowing rivers. The millions of larvae (microfilairae) released by the adult parasites invade skin and eyes where they can cause severe manifestations, including blindness. In addition, people suffer low self-esteem, experience social isolation, and worry that they will never marry. Poverty and famine are also increased as people move away from crop-producing fertile river areas to less fertile areas to avoid the fly’s habitat and thereby risk of contracting the disease. The disease is endemic in sub-Saharan Africa.
Since the late 1990s, the WHO-based Special Programme for Research and Training in Tropical Diseases (WHO/TDR) has worked extensively with industry, patient, and community groups to evaluate the use of moxidectin for the treatment of onchocerciasis. Moxidectin has shown to be significantly superior to the current standard of care in 2 clinical trials. Medicines Development for Global Health took over the sponsorship of moxidectin from WHO/TDR in 2014 and the product was approved by the United States Food and Drug Administration on June 13, 2018.
Scabies is a skin condition that is caused by a microscopic mite (Sarcoptes scabiei var. hominis) that is transmitted primarily through person-to-person contact. Infection can result in debilitating itchiness with associated sleep disturbance and reduced ability to concentrate. More seriously, infection has been associated with impetigo, septicemia, glomerulonephritis, and rheumatic heart disease. An estimated 100 million persons have scabies worldwide. The highest rates occur in countries with hot, tropical climates, where infestation is endemic.
While there are effective treatments for scabies, moxidectin is being developed as a single oral medicine to treat and prevent scabies infection.
Our initial focus was on the registration of moxidectin for the treatment of river blindness. This process was being funded via a $US13 million investment by the Global Health Investment Fund I, LLC (GHIF), which was used to fund the re-establishment of quality manufacture and testing of moxidectin, clinical pharmacology program, further non-clinical data, completion of the Phase III clinical trial, a pharmacokinetic and QT clinical study, and the compilation of the New Drug Application to the United States Food and Drug Administration.
We have committed to deliver moxidectin for onchocerciasis treatment on a cost recovery basis and, with GHIF, to continue to research other potential human uses of moxidectin.
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