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DNDi E-news - Scientific Update
December 2015   |   View Online

Breakthrough treatments for the most neglected diseases: diversifying approaches is required to expand the development pipeline with new chemical entities

 

Viewpoint by Graeme Bilbe, Research & Development Director, DNDi


DNDi’s initial short-term strategies were designed to quickly provide improved treatments through new formulations or combinations of existing drugs, and/or improved treatment regimens. Discovering and developing such new chemical entities, or NCEs, has been the key challenge for DNDi in carrying out its long-term strategy, set out 12 years ago, and has led us to embark on various new pathways and partnership models to achieve our goals. »

R & D Status November 2015

 
Human African Trypanosomiasis
SCYX-7158 progresses to Phase II/III trial in DRC, while the fexinidazole trial is ready for extension to Phase IIIb including new patient groups not yet included in the current trial. »

Leishmaniasis
VL&PKDL: Preparation of two Phase II PoC studies to assess fexinidazole/miltefosine combination and two treatments (AmBisome monotherapy and in combination with miltefosine) for PKDL.
CL: Phase II trial on Anfoleish progresses, while Phase II PoC study on new combination treatments is under preparation. »

Chagas disease
Preparations underway for Phase II PoC study of benznidazole monotherapy in new doses and durations and benznidazole / fosravuconazole combination regimens, in Argentina and Bolivia. »

Filarial diseases
A macrofilaricide drug is ready for testing in human volunteers in a Phase I study. »

Paediatric HIV
Large-scale implementation study on LPV/r pellets with NRTI FDC and preparation of Phase I study in human volunteers to test 4-in-1 LPV/r based FDC granules. »

Mycetoma
Preparation is underway for a Phase II PoC study to assess fosravuconazole in patients with eumycetoma in Sudan. »

New report reviews the successful development of the antimalarial ASAQ


 
Pioneering ways of working through innovative partnerships – 2002-2015
The successful development of a fixed dose combination of artesunate plus amodiaquine antimalarial

The antimalarial ASAQ is the first treatment delivered by DNDi and its partners. This new report summarises the key lessons learned »

World AIDS Day 2015:
Paediatric HIV Advocacy Toolkit &
LIVING study press release


The Paediatric HIV Advocacy Toolkit aims to create awareness among communities of the importance of early infant diagnosis and the rapid start of ARV treatment for infants and toddlers.
View the toolkit »

DNDi has begun an implementation study of a recently-approved paediatric ARV treatment.
Read the press release »

DNDi in the Media


The Observer: "Kala azar, the tropical disease only treatable in Amudat" »

Saúde! Brasileiros: "Cientistas discutem inovação para tratar doenças neglienciadas" »

Politico: "HHS forum foreshadows action on drug costs" »

The Guardian: "How to stop antibiotic resistance? Here's a World Health Organisation prescription" »

Daily Nation: "More needs to be done to treat kala-azar" »

RAPS: "Health advocacy groups call for changes to priority review voucher program" »

The Guardian: "Nobel prize winners point the way in battle against diseases of poverty" »

Speaking of Medicine - PLOS Community Blog: "Filarial Diseases and the Nobel Prize for Medicine: Going Even Further for Neglected Patients" »

El País: "Por una investigación más enfocada a la salud y menos al mercado" »

The Guardian: "Is it fair to accuse the pharma industry of neglecting tropical diseases?" »

L'actualité: "Trois Nobel de médecine pour mieux soigner les plus pauvres de la terre" »

Daily Nation: "My work is to fight neglected diseases" »

CNET Japan: "顧みられない患者さんを救うためにDNDiは新しい計画を発表しました" »

Nature: "Bugging out over Chagas: Bioluminescent protozoans and old drugs might help unravel kissing-bug disease" »

Business Standard: "DNDi lauds Nobel winners for advances in neglected disease research" »
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Nature Reviews Drug Discovery:
Hit and lead criteria in drug discovery for infectious diseases of the developing world »

Trials:
Generalizing boundaries for triangular designs, and efficacy estimation at extended follow-ups »

Mutagenesis:
Genotoxicity of flubendazole and its metabolites in vitro and the impact of a new formulation on in vivo aneugenicity »
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