DNDi: New Drug for Sleeping Sickness Coming Soon

By Gift Briton

Drugs for Neglected Diseases initiative (DNDi) and Sanofi have co-developed a single oral dose(Acoziborole) treatment that could help eliminate sleeping sickness disease with the drug showing a success rate of up to 95% from Phase II/III study investigating its safety and efficacy.

Acoziborole, unlike current treatments for sleeping sickness, does not require multiple days of treatment, hospitalization or highly skilled health personnel, with experts arguing that it could be a breakthrough in efforts to reach the World Health Organization(WHO) goal of the elimination of transmission of sleeping sickness by 2030.

Speaking during Africa Science Media Centre(AfriSMC) press briefing dubbed The Sleeping Sickness Disease, Current Treatment Situation and Challenges, Dr Wilfried Kalonji, Clinical Project Leader and Medical Manager DNDi said that the drug has very good tolerability and high efficacy.

He added that “it is less cumbersome, therefore it can be used in very remote areas. With the clinical trial already done, the next step will be registration process by the affected country and once it is already registered, other countries will be free to acquire the drug.”

According to Kalonji, elimination of sleeping sickness requires involvement of governments, research institutions and strong partnerships noting that the drug will be supplied to interested countries through the WHO.

Sleeping sickness (human African trypanosomiasis), a neglected tropical disease transmitted by the bite of an infected tsetse fly commonly found over parts in sub-Saharan Africa, is fatal without treatment. In the last decade, 70% of the cases reported happened in the Democratic Republic of Congo(DRC), with over 20% of the infections happening in children.

It manifests in two stages including the first stage (haemo-lymphatic stage), where symptoms such as fever or chills may be experienced making it more likely to be missed or misdiagnosed.

In the second stage (meningo-encephalitic stage), serious neurological disorders including sleep cycle disruptions, neurological manifestations, and progressive mental deterioration which may lead to death occur. However, current diagnosis and treatment of the disease is complex and requires staff with special skills.

Until 2019, treatment for patients in the earlier stage of the disease was a daily injection for seven or more days and, for patients in the later disease stage, an intravenous drip for seven days, which requires hospitalization.

Furthermore, patients were also required to undergo a spinal tap, where fluid is collected from the spine, to diagnose the stage of sleeping sickness to determine the most appropriate treatment. In 2019 fexinidazole was introduced, a 10-day oral drug developed by DNDi as a first-line treatment for both stages of the disease, but its administration still requires skilled staff and, often, hospitalization.

“Sleeping sickness threatens millions of people across sub-Saharan Africa. Many of the people at risk live in remote rural areas where there is little access to adequate health services, and where acoziborole has the potential to revolutionise treatment for sleeping sickness,” says Dr Antoine Tarral, Head of Human African Trypanosomiasis Clinical Program at DNDi, and lead author of the study.

“It is administered in a single dose and is effective across every stage of the disease, thereby eliminating the many barriers currently in place for people most vulnerable to the diseases, such as invasive treatments and long travel distances to a hospital or clinic, and opening the door to screen-and-treat approaches at the village level.”

To test its efficacy, the organization recruited 208 patients from 10 hospitals in the Democratic Republic of Congo and Guinea, and administered each with a single 960 mg oral dose of acoziborole.

The patients were followed up for 18 months to see if treatment was successful. The success rate for patients with late stage of the disease is 95% while it was 100% in early stage patients. Also, mild events and low proportion of side effects related to treatment was noted with no significant drug-related safety signals being identified.

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