The discovery of a single dose drug (acoziborole’), an oral treatment against sleeping sickness, has raised hope in the quest to contain the disease in Africa.
The single dose new chemical entity, is to be issued from the Drugs for Neglected Diseases initiative (DNDi’s) as the lead optimization programme for sleeping sickness.
Research on the drug started with an initial hit identified in the chemical library of Anacor Pharmaceutical which was acquired by Pfizer way back in 2016.
Acoziborole’s potential in the treatment study for the deadly disease has reached phase 2/3 with renewed hope for the patients as DNDi and Sanofi (a research organization) announced the treatment success of up to 95%.
In a statement released to media houses dated November 30th 2022 from Geneva/Kinshasa/Paris all at the same time stated that the study has been investigating the safety and efficacy of the single dose acoziborole’ which is a potentially investigational treatment for sleeping sickness.
The research findings attributed to Frederic Ojardias (DNDi Geneva), Victor Rouault-Sanofi (France) and Evan Berland (USA) revealed that the drug’s initial structure was finally optimized with Scynexis and Pace University and was then selected as a candidate for further development.
Kenya News Agency (KNA) has since established that the first phase of the study was conducted successfully in France. Acoziborole’ has now become the latest innovation brought about by two decades of innovation efforts by DNDi, Sanofi and their partners.
The findings revealed that a donation programme was set up by Sanofi and Bayer, which in 2009 proceeded to develop a combination of existing drugs known as NECT which was extremely effective and much safer than the toxic Arsenic derivative that doctors were to use at the time.
NECT was being used free of charge in endemic countries through the World Health Organization (WHO) which radically improved treatment options for the patients.
However, the statement attributed to the trio; Ojardias (DNDi), Rouault (Sanofi), Berland(US) pointed out that NECT requires complex logistics with each treatment weighing 8kg and so must be administered in hospital settings by skilled staff.
Subsequently, DNDi, Sanofi and partners developed another drug called fexinidazole which in 2018 became the first all-oral treatment available at the time for sleeping sickness. This 10-day treatment is now available in all sleeping sickness endemic countries.
Acoziborole’ can be administered as a single oral dose, meaning treatment could be provided at the village level; healthcare workers from mobile teams will be able to immediately administer the single dose as soon as the patient is diagnosed without the need for hospitalization or supervision of the treatment at home.
This, they pointed out, means that it could ultimately become a major tool to facilitate efforts to finally eliminate sleeping sickness.
DNDi is a not-for-profit research and development organization, focused on delivering new treatments for neglected patients living with such diseases such as Chagas, sleeping sickness (human African trypanosomiasis), leishmaniasis, filarial infections, mycetoma, paediatric HIV, Hepatitis c and Dengue fever.
The organization is also coordinating the clinical trials (ANTICOV) to find treatments for people with mild-to moderate Covid-19 living in low-settings (poor environment).
These pivotal results will form the basis of Sanofi’s dossier submission to the European Medicines Agency (EMA) and represent another milestone in the quest to eliminate sleeping sickness. The drug will finally be donated to WHO through the respective philanthropic for further clinical investigation, evaluation, safety and efficacy by any regulatory authority.
Since its inception in 2003, DNDi has delivered 12 new treatments, including new drug combinations for leishmaniasis, two fixed dose antimalarial and DNDi’s first successful developed new chemical entity, Fexinidazole drug approved in 2018 for the treatment of both stages of sleeping sickness.
Sanofi, on the other hand, is an innovative global healthcare company driven by the purpose of chasing the miracles of science to improve people’s lives. It has a team spread across 100 countries and is dedicated to transforming the practice of medicine by working to turn the impossible into the possible.
The organization provides potentially life changing treatment options and lifesaving vaccine protections to millions of people globally, while putting sustainability and social responsibility at the centre of human beings’ ambitions.
By Joseph Ouma and Gift Sherwood