Wyeth and the World Health Organization (WHO) have announced that they have agreed to proceed with a clinical trial to investigate the safety and efficacy of moxidectin in onchocerciasis (river blindness) infected individuals. This could be a first step towards a new treatment for onchocerciasis, the world's second leading infectious cause of blindness.
This announcement is the culmination of an informal three-year cooperative effort to develop an oral formula for moxidectin and to conduct the pre-clinical analyses and regulatory filings required before initiating a clinical trial in patients.
A Phase II "proof of concept" clinical trial will now begin at WHO's Onchocerciasis Chemotherapy Research Centre in Hohoe, Ghana and will be conducted by the WHO Special Programme for Research and Training in Tropical Diseases (TDR). Wyeth will be responsible for providing clinical supplies, as well as the resources for data management and analysis.
"We are pleased to collaborate with WHO on this project and to contribute Wyeth's expertise to the development of an alternative to existing treatments," says Bernard Poussot, president, Wyeth Pharmaceuticals
Onchocerciasis, often referred to as river blindness, is a parasitic disease endemic in 36 countries in Africa, the Arabian Peninsula and Central and South America. It is caused by the nematode Onchocerca volvulus (parasitic worm), and is transmitted to humans through the bite of a black fly that breeds in fast running streams. With each bite, an infected black fly deposits several larvae that develop into mature adult worms in about one year. These adult worms live for up to 14 years in the human body producing millions of larvae that migrate throughout the body and give rise to a variety of symptoms including rashes, skin lesions and serious visual impairment that can lead to blindness.
Wyeth is collaborating with WHO/TDR, to determine if moxidectin, due to the pronounced effect on adult worms observed in animal models, could be an addition to the efforts to control the disease.
"From a scientific perspective, we see great potential for moxidectin in controlling and possibly accelerating the elimination of this debilitating condition as a health problem and to improving the lives of millions of individuals in the countries where river blindness constitutes a serious threat and an impediment for socioeconomic development," says Robert R. Ruffolo, president, Wyeth Research.
"This agreement is another example of how the private and public sector can bring together their respective areas of competence towards developing tools to address public health needs of poverty stricken populations. The study to be initiated is not only a key step towards evaluating the potential of moxidectin as a drug that might change the current paradigm of onchocerciasis control, but also is one more step towards building drug development capacity in disease endemic countries. We believe that this capacity-building may further leverage the involvement of the pharmaceutical industry not only to address onchocerciasis but other neglected diseases as well," says Dr. Janis K. Lazdins-Helds, the WHO/TDR Disease Research Coordinator for Onchocerciasis and the manager of the joint TDR /APOC project for Research and Development of products for Onchocerciasis.