SWITZERLAND – Novartis and the Drugs for Neglected Diseases initiative (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.
Visceral leishmaniasis, also known as kala-azar, is the most serious form of leishmaniasis, causing fever, weight loss, spleen and liver enlargement, and if left untreated, death.
A joint statement by the two companies described LXE408 as “a first-in-class compound, discovered at Novartis with financial support from the Wellcome Trust.”
Within the scope of the agreement, Novartis is responsible for completing Phase I clinical trial and will drive pharmaceutical development and regulatory submissions.
Upon approval, Novartis has committed to distributing the drug on an affordable basis worldwide with a focus on maximizing access in endemic countries.
DNDi, a not-for-profit research and development (R&D) organization, will lead Phase II and Phase III clinical development, with the first Phase II study scheduled to start in early 2021 in India.
Over one billion people worldwide are at risk of leishmaniasis, which is transmitted by the bite of a sand fly.
There are an estimated 50 000 to 90 000 new cases per year. Treating the disease is complex as it is dependent on the species of infecting parasite and the country, as treatment responses differ from region to region.
“Existing treatments for visceral leishmaniasis are simply not good enough. They are too long, increasingly ineffective, and can be toxic, painful, and costly,” said Dr Bernard Pécoul, Executive Director of DNDi.
“Our hope is to radically transform this by developing new oral drugs that are affordable, safe, effective, easy to take, and can also be adapted to meet the treatment needs of patients in different countries.”
The collaboration between DNDi and Novartis is aligned with a broader program with Wellcome and other partners to develop new combinations of entirely new, all-orally acting chemical entities, to treat visceral leishmaniasis and cutaneous leishmaniasis, another form of the disease.
The program brings together a strong consortium of R&D partners, including the University of Dundee, GSK, Pfizer, TB Alliance, and Takeda Pharmaceutical Company Limited.
These partners have built a portfolio of lead series, pre-clinical and clinical drug candidates, originating from different chemical classes with different mechanisms of action against leishmania parasites.