The Japanese pharmaceutical company Astellas Pharma Inc. is the eighth pharmaceutical company to join the Neglected Tropical Diseases Drug Discovery Booster, a global consortium launched in 2015 by DNDi to speed up the process and cut the cost of finding new treatments for leishmaniasis and Chagas disease.
Daiichi Sankyo RD Novare and DNDi are pleased to announce the financial support of the Japan Global Health Innovative Technology Fund to their new collaboration on natural products.
Phase II/III study results confirmed that fexinidazole, DNDi’s first new chemical entity is safe and effective, and presents significant advantages over current treatment as it removes the need for lumbar puncture and systematic patient hospitalization. A regulatory dossier has been submitted to the European Medicines Agency for fexinidazole as the first all-oral treatment for sleeping sickness.
Three new chemical entities entered the pre-clinical pipeline, bringing to six the number of new compounds progressing in the leishmaniasis portfolio, with two already nominated as clinical candidates to progress to Phase I. The first patient was recruited in India in Phase II studies to test new treatments for PKDL, while clinical sites were being prepared in Bangladesh and Sudan. A site was initiated in Sudan for a Phase III study to test a new combination treatment for leishmaniasis in the African region. In Latin America, a Phase II study on new combination treatments for cutaneous leishmaniasis progressed well.
Two Phase II trials are ongoing, with the study in Bolivia on benznidazole for improved treatment of chronic indeterminate Chagas disease having completed recruitment at the end of 2017, and a study in Spain in the early stages of patient recruitment to evaluate fexinidazole as Chagas treatment. A pilot project to increase access to diagnosis and treatment in five endemic communities in Colombia showed excellent interim results and will report one-year results in mid-2018. In 2018, DNDi and Fundación Mundo Sano will launch a new Chagas Disease Regional Access Framework.
The portfolio of potential filaricidal treatments continues to progress, with emodepside (Bayer) and the antibiotic TylAMac (AbbVie) that have entered healthy volunteer Phase I studies with other pre-clinical candidates.
The first-ever double-blind, randomized clinical trial for eumycetoma (fungal mycetoma), being conducted in Sudan, had enrolled 20 patients by the end of 2017. The primary objective of the study is to demonstrate the superiority of fosravuconazole over the current treatment, itraconazole.
A first-line “4-in-1” fixed-dose combination (abacavir/lamivudine/lopinavir/ritonavir) is on track to be submitted for registration in late 2018. Preliminary results from the LIVING study for an interim optimized paediatric formulation were presented at the end of 2017, showing that these “oral pellets” are effective, well tolerated and well accepted by caregivers and children.
All 301 patients in DNDi’s Phase II/III trial combining ravidasvir and sofosbuvir in Malaysia and Thailand have completed treatment. Top-line results are being analysed and will be published in April 2018.
A l’occasion de l’Evénement économique 2017 du 9 novembre dernier, la Chambre de commerce, d’industrie et des services de Genève (CCIG), le Département de la sécurité et de l’économie (DSE) et l’Office de Promotion des Industries et des Technologies (OPI) ont décerné le Prix 2017 de l’innovation à l’initiative Médicaments contre les Maladies Négligées (DNDi).
As part of the ‘Evénement économique 2017’ that took place on November 9, the Geneva Chamber of Commerce, Industry and Services (CCIG), the Department of Security and Economy (DSE) and the Office for the Promotion of Industries and Technologies (OPI) awarded the Innovation Prize 2017 to the Drugs for Neglected Diseases initiative (DNDi).
DNDi is very pleased to announce the renewed commitment of the Global Health Innovative Technology Fund (GHIT), its donor since 2013, to DNDi projects on leishmaniasis and mycetoma disease
Combining patient data from visceral leishmaniasis clinical trials would give scientists and clinicians more tools to understand and treat the disease which can be fatal if untreated.
GARDP has set up its team, scientific advisory committee, and R&D strategy. Three programmes are underway: neonatal sepsis, gonorrhoea, and an initiative to recover and connect the vital knowledge of scientists in antibiotic drug development. In recent weeks, both the G20 Health Ministers and outgoing WHO Director-General Margaret Chan have expressed support for GARDP and called for more R&D into drug-resistant infections.
DNDi is very pleased to announce the renewed commitment of the Global Health Innovative Technology Fund (GHIT), its donor since 2013, to DNDi projects on leishmaniasis and Chagas disease.
Fexinidazole entered into the last stage of clinical development before potential submission to regulatory authorities in 2017 as the first new oral treatment for sleeping sickness, while SCYX-7158* moved to Phase II/III.
Two new chemical entities were nominated as pre-clinical candidates for visceral leishmaniasis, and two Phase II studies to test new treatments for PKDL were designed for launch in Bangladesh, India and Sudan in 2017.
A proof-of-concept study was launched in Bolivia (soon to be extended to Argentina) testing, in patients with chronic Chagas disease, new benznidazole regimens and durations and in combination with fosravuconazole.
Emodepside entered into healthy volunteer Phase I studies in 2016; ABBV-4083 (Tylamac)* entered into full pre-clinical development for the treatment of filarial diseases.
The results of the HIV/TB co-infection ‘super-boosting’ study prompted a change in WHO guidelines, confirming the evidence around the need to increase ritonavir dosages to counter drug-drug interactions.