January 8, 2016
Indicated disease(s) : Eumycetoma
Technology title : E1224 (fosravuconazole) – Phase II clinical study of an antifungal drug candidate for eumycetoma
Mycetoma is a chronic, progressive, localized infectious disease caused by bacteria or fungi, which generates tumor-like lesions in subcutaneous tissue of limbs, and as tissues are destroyed, the functionality of the affected limbs is reduced. There is a considerable lack of information regarding the propagation, prevalence, routes of infection and sensitivity to treatment for mycetoma.
Eumycetoma, which is caused by fungi, is mostly seen in Africa and other tropical and subtropical regions, and is particularly widespread in Sudan. Although the precise route of infection is not clearly understood, it is likely that infection most commonly occurs when the fungi enter the skin when walking barefoot over contaminated thorns of plants. The main symptom of the disease is the appearance of massive lesions on hands and feet, which pose difficulties for walking and working as the condition progresses. In endemic regions, the disease has social consequences such as discrimination caused by prejudice and economic damage to those suffering of it.
Currently there are limited options for treatment by antifungal drugs, which are expensive, unsafe, and only cure about 30% of patients even after twelve months of treatment. Those who aren't cured are at risk of repeated excision of destroyed tissue and amputation as the infection spreads throughout the body, and therefore a real need exists for the development of new treatments.
Eisai has signed an agreement with the Drugs for Neglected Diseases initiative (DNDi) (Headquarters: Geneva, Switzerland) to jointly develop Eisai's azole-class antifungal drug E1224 (fosravuconazole) as a potential new treatment for eumycetoma. Ravuconazole, the active form of E1224, has shown strong antifungal activity against the eumycetoma-causing fungi in preclinical experiments1. Through the signing of this agreement, Eisai and DNDi will conduct clinical development to assess safety and efficacy of fosravuconazole in patients with Eumycetoma. Clinical studies are scheduled to start in 2016, and will be conducted by DNDi in collaboration with the Mycetoma Research Center of the University of Khartoum, Sudan.
- 1PLoS Negl Trop Dis. 2014 Jun 19;8(6):e2942. doi: 10.1371/journal.pntd.0002942. eCollection 2014.