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[e-drug] DNDi launches P-1 clinical trial for oral drug for sleeping sickness

E-DRUG: DNDi Launches Phase I In-Human Clinical Trial for Promising Oral Drug 
for Sleeping Sickness 

[Geneva, Switzerland - 12 March 2012] - The Drugs for Neglected Diseases 
initiative (DNDi) has commenced a Phase I clinical trial in healthy adults in 
Paris, France, to determine the safety and tolerability of a promising oral 
drug candidate Oxaborole SCYX-7158, to treat human African trypanosomiasis 
(HAT, or sleeping sickness) for stage 1 and stage 2 of the disease.
This randomized, double-blind, placebo-controlled study will assess the safety, 
tolerability, pharmacokinetics and pharmacodynamics of SCYX-7158 in healthy 
volunteers. The study is a combined trial including three sequential parts: 
first, administration of single oral ascending doses; second, concomitant food 
intake with single oral dose administration, in order to assess the 
bioavailability of SCYX-7158 (food effect); and third, administration of 
multiple oral ascending dose. The study is taking place in a Phase I unit in 
Paris, at SGS Aster, and will recruit up to 120 volunteers.

Approval for the study was obtained from a French Ethics Committee (Comité de 
Protection des Personnes) and the French Regulatory Authority AFSSAPS (Agence 
Française de Sécurité Sanitaire des Produits de Santé).

'This is an important milestone in our efforts to build and maintain a strong 
pipeline for new oral treatments against sleeping sickness. DNDi and its 
partners are committed to harnessing all of the efforts and expertise necessary 
to support the WHO goal of eliminating this disease by the year 2020. New oral 
treatments that can be administered at the field level would be a vital part of 
this', comments Dr Bernard Pécoul, Executive Director, DNDi. 

Oxaborole SCYX-7158 is DNDi's first clinical candidate issued from the DNDi 
Lead Optimization Consortium to enter Phase I trials. The development of the 
compound was the result of a unique collaboration between DNDi and Anacor 
Pharmaceuticals (USA), SCYNEXIS (USA), within a consortium including also Pace 
University (USA) and the Swiss Tropical and Public Health Institute 
(Switzerland). Together they worked on the Oxaboroles series and amongst the 
molecules studied, SCYX-7158 was selected for its very promising pre-clinical 

If Oxaborole SCYX-7158 progresses successfully through Phase I clinical trials, 
DNDi plans to advance the treatment into a multi-center Phase II trial in 
sub-Saharan African countries where the disease occurs. 


About sleeping sickness
Sleeping sickness, which threatens millions in 36 countries in sub-Saharan 
Africa, is fatal if left untreated. The disease is caused by parasites 
transmitted by the bite of a tsetse fly and is often asymptomatic for years 
(stage 1) until the infection reaches stage 2, where it crosses into the 
central nervous system and brain.  Currently available treatments are limited 
to drugs developed decades ago that are either highly toxic, difficult to 
administer in resource-limited settings, or are only effective in one stage of 
the disease. In addition, prior to being treated, the stage of the disease must 
be determined using a diagnostic spinal tap to extract cerebrospinal fluid from 
the patient.   

About the partnership 
A collaboration led by the Drugs for Neglected Disease initiative (DNDi) 
combined Anacor Pharmaceuticals' novel boron chemistry with the chemistry and 
parasitology expertise at SCYNEXIS. A scientific consortium led by DNDi and 
including SCYNEXIS, Pace University, Swiss Tropical and Public Health 
Institute, and Anacor worked on the optimization of a series of benzoxaboroles, 
which led to the discovery of SCYX-7158. Advinus Therapeutics conducted 
toxicology testing on the compound. The project has mostly been supported by 
the Bill & Melinda Gates Foundation and the Ministry of Foreign and European 
Affairs (MAEE), France. Additional funding is provided by the Department for 
International Development (DFID), UK, Dutch Ministry of Foreign Affairs (DGIS), 
The Netherlands, Spanish Agency of International Cooperation for Development 
(AECID), Spain, Federal Ministry of Education and Research (BMBF), Germany, 
Swiss Agency for Development and Cooperation (SDC), Switzerland, and Doctors 
Without Borders/Médecins Sans Frontières (MSF).   
For more information on the partnership: 

About DNDi
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research 
and development organization working to deliver new treatments for neglected 
diseases, in particular sleeping sickness (human African trypanosomiasis), 
Chagas disease, leishmaniasis, specific helminth infections, malaria, and 
paediatric HIV. DNDi was established in 2003 by Médecins Sans 
Frontières/Doctors Without Borders (MSF), the Oswaldo Cruz Foundation (FIOCRUZ) 
of Brazil, the Indian Council of Medical Research (ICMR), the Kenya Medical 
Research Institute (KEMRI), the Ministry of Health of Malaysia, and the Pasteur 
Institute of France. The Special Programme for Tropical Disease Research 
(WHO/TDR) serves as permanent observer. 
Since its inception in 2003, DNDi has delivered six new treatments for 
neglected patients: two fixed-dose antimalarials (ASAQ and ASMQ), 
nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping 
sickness, sodium stibogluconate and paromomycin (SSG&PM) combination therapy 
for visceral leishmaniasis in Africa, a set of combination therapies for 
visceral leishmaniasis in Asia, and a paediatric dosage form of benznidazole 
for Chagas disease.
DNDi has helped establish three clinical research platforms: Leishmaniasis East 
Africa Platform (LEAP) in Kenya, Ethiopia, Sudan, and Uganda; the HAT Platform 
based in the Democratic Republic of Congo (DRC) for sleeping sickness; and the 
Chagas Clinical Research Platform in Latin America. Strong regional networks 
such as these help strengthen research and treatment-implementation capacity in 
neglected disease-endemic countries.

Media contact 
Violaine Dällenbach
Press and Communications Manager
office: +41 22 906 92 47
mobile: +41 79 424 14 74
email: vdallenbach@dndi.org 

Drugs for Neglected Diseases initiative (DNDi)
15 Chemin Louis-Dunant - 1202 Geneva - Switzerland
Best Science for the Most Neglected: www.dndi.org

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