references
R&D MODEL & PORTFOLIO
New treatments developed from compounds with known antimicrobial/ antiparasitic activities aiming to maintain or improve efficacy and tolerability. Compound repurposing for new indications of existing treatments in other diseases (therapeutic switching).
Combinations or new formulations of existing drugs that are better adapted to field conditions and patient needs (paediatric dosage forms, long-acting forms, new route of administration, fixed-dose combinations, co-packaging, or co-administration). Geographical extension of existing treatments, including completion of regulatory dossiers in new countries.
Implementation
Access
KEY R&D MILESTONES IN 2015
DISCOVERY
• Successful implementation of NTD Drug Discovery Booster • New series in H2L and lead optimization for leishmaniasis and Chagas disease • Screening of 300,000 compounds from pharmaceutical and other libraries completed • Two optimized lead candidates under review for VL with backup compounds in three different chemical classes – including one very potent for CL
NECT
Nifurtimox-Eflornithine Combination Therapy
SSG&PM
Africa
HUMAN AFRICAN TRYPANOSOMIASIS (HAT)
• Recruitment to three fexinidazole studies (pivotal late stage, early stage, children) completed • Phase I study for SCYX-7158 completed
New VL Treatments
Asia
LEISHMANIASIS
• DNDI-0690 nominated as new pre-clinical candidate for VL • Miltefosine allometric dosing study recruitment completed in Africa • Dose selection and decision to initiate drug-drug interaction study on fexinidazole/miltefosine as a potential oral combination in Africa • Development of PKDL study for India and PKDL infectivity study in Bangladesh • Study on new VL treatments in Latin America completed • 12-month follow-up of VL-Asia study ongoing – collaboration with Kalacore for further implementation and pharmacovigilance monitoring
Benznidazole
Paediatric Dosage form
CHAGAS DISEASE
• Drug-drug interaction study completed for E1224/benznidazole • Development of study protocol for short-course benznidazole as well as benznidazole/E1224 combination
FILARIAL DISEASES
• Pre-clinical development for emodepside completed
PAEDIATRIC HIV
• Interim positive results for TB Superboosting study • LIVING study on the implementation of pellets initiated in Kenya
Malaria
ASAQ FDC ASMQ FDC
MALARIA
• ASAQ and ASMQ transferred to MMV • ASAQ technology transfer to Zenufa: preparation of prequalification file • >400 million ASAQ treatments delivered by Sanofi
December 2015
DNDi Annual Report 2015 › 17