2019 R&D portfolio in review: Leishmaniasis

Short-term strategies to develop better treatment regimens using existing drugs progressed, with Phase IIb/III studies in Africa testing new regimens for visceral leishmaniasis (VL) and post-kala-azar dermal leishmaniasis (PKDL) and a Phase II study in South Asia testing a new regimen for PKDL. Results from HIV/VL Phase III studies in Ethiopia and India were presented to national and international authorities to inform review of HIV/VL treatment guidelines. In addition, multiple new chemical entities have progressed in pre-clinical and Phase I studies, marking significant progress toward DNDi’s long-term goal of developing an entirely new generation of all-oral drugs for VL.

For cutaneous leishmaniasis (CL), preliminary results from a Phase II study in Latin America showed the combination of thermotherapy with a shorter course of oral miltefosine to be significantly better than thermotherapy alone for the treatment of uncomplicated CL in the Americas.

Novartis and DNDi to collaborate on the development of a new oral drug to treat visceral leishmaniasis

Basel, Switzerland – 25 February 2020

  • LXE408 is a first-in-class compound, discovered at Novartis with financial support from the Wellcome Trust
  • Novartis is responsible for completing Phase I clinical trials and has committed to maximizing access in endemic countries, once approved
  • DNDi will lead Phase II and III clinical development, starting in India with additional trials planned in East Africa
  • Leishmaniasis, which is transmitted by the sandfly, affects over one billion people; visceral leishmaniasis, the most serious form of the disease, affects an estimated 50 000 to 90 000 people per year

Novartis and DNDi have signed a collaboration and licence agreement to jointly develop LXE408, as a potential new oral treatment for visceral leishmaniasis, one of the world’s leading parasitic killers.

Brazil’s Ministry of Health and CNPq to invest in researching new treatments for leishmaniasis and Chagas disease

Brasilia, Brazil – 5 December 2019
Studies may lead to therapeutic alternatives for people living with these neglected tropical diseases
The Brazilian Ministry of Health (the Department of Science and Technology of the Science, Technology and Strategic Inputs Secretariat – Decit/SCTIE) and CNPq (National Council for Scientific and Technological Development) will invest around R$ 1,5 million (US$ 370,000) in research that may lead to the development of a new treatment option for cutaneous leishmaniasis.