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 (Comit- de Protection des Personnes) and the French Regulatory Authority AFSSAPS (Agence Fran-aise de S-curit- Sanitaire des Produits de Sant-).
'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 P-coul, 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 results.
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.