Home Overview Key Accomplishments

Key Accomplishments

A number of achievements have been reached in a relatively short period of time. All such achievements are milestones along the way to achieving DNDi’s vision:

Portfolio

DNDi has built a portfolio focused on HAT, leishmaniasis, Chagas disease and Malaria, which serves the primary R&D objective of making six-eight new treatments available to patients by 2014. In 2011, DNDi started taking on specific projects for two new disease areas: Paediatric HIV and Helminth infections (more specifically filarial diseases).

Malaria

ASAQ – fixed-dose combination (FDC) of artesunate and amodiaquine for use in sub- Saharan Africa; launched in March 2007; registered in 31 disease-endemic countries; in landmark partnership with Sanofi; obtained WHO prequalification in October 2008; more than 100 million treatment courses delivered by mid-2011.

ASMQ – FDC of artesunate and mefloquine for treatment in Latin America and Asia; registered in Brazil in March 2008 in partnership with Farmanguinhos/ Fiocruz; South-South technology transfer to Cipla completed in 2010 for availability in Asia and Africa; in use by Brazilian national authorities.

Human African Trypanosomiasis

NECT – Nifurtimox-Eflornithine Coadministration Therapy included in the WHO Essential Medicines List (EML) in 2009. First new improved treatment in 25 years for stage 2 HAT. Available in 10 African countries, covering 97% of reported HAT cases. More than 6’000 treatments distributed. More than 60% of stage 2 patients treated with NECT replacing toxic melarsoprol used previously.

Fexinidazole – first compound mining success from DNDi’s nitroimidazoles project; entered into clinical development in 2009; in May 2009, Sanofi and DNDi signed agreement to develop and make it available; Phase I of clinical study is being finalized.

Oxaborole SCYX-7158 – In June 2011, DNDi, Anacor Pharmaceuticals, and SCYNEXIS Inc. completed the pre-clinical studies for the first new oral drug candidate discovered specifically to combat HAT, Oxaborole SCYX-7158, which has shown safety and efficacy and will soon advance to Phase I human clinical trials.

Lead Optimization Partnership – The two compound series mentionned above were advanced as attractive leads progressing from early-stage screening research through innovative partnership with U.S. partners: Scynexis & Pace University. DNDi's current strategy for the Consortium is to develop a back-up compound in each of the oxaborole and nitroimidazole series.

Leishmaniasis

Visceral Leishmaniasis (VL)Combination Trials in Africa, Asia and Latin America – implemented for evaluating safe and short-course combination therapy, using existing drugs in three regions to stave off parasitic resistance and provide a shorter, more effective treatment course;
  • - SSG&PM (Africa): Combination Treatment of Sodium Stibogluconate and Paromomycin launched by DNDi in 2010. Recommended by the WHO Expert Committee as first-line treatment for VL in East Africa. Available in Northern and Southern Sudan.

  • - Phase III trial (Asia) In 2010, a study investigating the three possible 2-drug combinations of AmBisome, Miltefosine and Paromomycin was completed in India. All three combination treatments were shown highly efficacious (> 97.5% cure rate). A trial has been initiated in Bangladesh and an other one should stard in Nepal. A WHO Expert committee recommended these treatments to be used preferentially to current established monotherapy treatments for VL in South Asia. DNDi is working with TDR and iOWH to facilitate their introduction.
Lead Optimization Partnership – partnership implemented in 2007 with two key partners in India: Advinus and Central Drug Research Institute (CDRI); Assessments of four series of synthetic compounds, provided by DNDi partners, have been carried out or are ongoing. Recently, the thiazole series identified from a large screening campaign performed at Institut Pasteur Korea (IPK) has yielded potent lead molecules.

Chagas disease

Paediatric Benznidazole – agreement with LAFEPE to develop first benznidazole formulation for children; to be affordable and publicly available soon

E1224 & Biomarkers - The current project evaluates E1224, a new generation azole compound, for the treatment of Chagas disease. It is being advanced into Phase II efficacy and safety evaluation in Bolivia. DNDi will evaluate selected biomarkers for their potential aplication in clinical research on Chagas diseasr.

Lead Optimization Partnership – the project started in 2008 with the aim of progressing molecules from early-stage screening research. The efforts are now concentring on the fenarimol and the oxaboroles series. Partners include: Centre for Drug Candidate Optimisation (CDCO), Epichem, & Murdoch University (Australia); Federal University of Ouro Preto (Brazil).

Discovery Projects

Consolidation with strategic focus on compound collection, target identification, target validation, assay development, high-throughput screening (HTS), hit identification, and hit to lead selection. HTS is available for VL and Chagas (Institut Pasteur Korea) and for HAT (Eskitis). DNDi is working closely with Swiss TPH, Dundee University, London School of Hygiene & Tropical Medicine (LSHTM), University of Antwerp as well as developing synergies with Medicines for Malaria Venture (MMV), Global Alliance for TB Drug Development (GATB), and the Consortium for Parasitic Drug Development (CPDD). DNDi has established working relations with GSK, sanofi-aventis, Merck, Novartis, Pfizer and many others. See More

Strengthening Research Capacities

Three regional networks for research capacity strengthening.
Africa: the HAT Platform and the Leishmaniasis East Africa Platform (LEAP): GCP, ethics, and trial-monitoring training; establishment and training of data safety monitoring board (DSMB); workshops on clinical trial methodology and information sharing on recent clinical research developments.

Latin America: The Chagas Platform: The main objective is to facilitate clinical research by creating a forum for technical discussions, to develop a critical mass of expertise and to strengthen institutional research capacities.


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