A multi-center, open-level, phase II/III clinical trial has recently been conducted to evaluate the efficacy and safety of the oral antimicrobial drug acoziborole in patients with human African trypanosomiasis (HAT). The findings of the trial have been published in The Lancet Infectious Diseases.
HAT, also known as sleeping sickness, is a neglected tropical disease caused by the parasite Trypanosoma brucei gambiense, transmitted by the tsetse fly. HAT is endemic to sub-Saharan Africa, particularly in the Democratic Republic of the Congo.
Treatment approaches with HAT depend on the disease stage. At the early-stage disease, an intramuscular injection of pentamidine is given to treat the infection. However, the late-stage disease requires more powerful treatment because of the presence of the parasite in the brain.
Late-stage HAT is conventionally treated with nifurtimox-eflornithine combination therapy (NECT), which requires hospital admission. Only one oral drug known as fexinidazole with a 10-day treatment regimen is currently available for treating late-stage HAT; however, it is uncertain whether this drug can reduce disease severity.
The Drugs for Neglected Diseases initiative, in collaboration with Anacor Pharmaceuticals and Scynexis, has discovered acoziborole, another oral drug, for the treatment of late-stage HAT. In preclinical trials, acoziborole has been shown to be an effective antimicrobial against Trypanosoma brucei gambiense.
In the current multi-center, open-level, prospective phase II/III clinical study, scientists determine the therapeutic efficacy and safety of acoziborole in patients with laboratory-confirmed HAT.
A total of 208 patients aged 15 years and above were recruited from ten hospitals in the Democratic Republic of the Congo. Of all participants, 167 had late-stage HAT, and 41 had early-stage HAT.
The participants were orally administered a single 960 mg dose of acoziborole. The patients were observed for 15 days in the hospital. After hospital discharge, they were followed up at three, six, 12, and 18 months.
Given the high efficacy and favourable safety profile, acoziborole holds promise in the efforts to reach the WHO goal of interrupting HAT transmission by 2030.
Bill & Melinda Gates Foundation, UK Aid, Federal Ministry of Education and Research, Swiss Agency for Development and Cooperation, Médecins Sans Frontières, Dutch Ministry of Foreign Affairs, Norwegian Agency for Development Cooperation, Norwegian Ministry of Foreign Affairs, the Stavros Niarchos Foundation, Spanish Agency for International Development Cooperation, and the Banco Bilbao Vizcaya Argentaria Foundation.
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