Novartis and the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development (R&D) organization, have agreed to collaborate to develop LXE408, a new oral treatment for visceral leishmaniasis, a potentially fatal disease caused by Leishmania parasite.
LXE408, which is a first-in-class drug, was discovered at Novartis. The experimental drug is now completing the phase I clinical trials. On receiving approval, the company has committed to maximizing its access on an affordable basis worldwide with a focus on maximizing access in endemic countries.
DNDi will lead phase II and III clinical development of LXE408, which will be initiated in India with additional trials planned in East Africa.
The first phase II study is scheduled to start in early 2021 in India followed by trials in East Africa, which has the highest burden of visceral leishmaniasis.
Visceral leishmaniasis, also known as kala-azar or black fever is the most serious form of leishmaniasis which is transmitted by the sandfly. The disease that affects an estimated 50 000 to 90 000 people per year causes fever, weight loss, spleen and liver enlargement, and if left untreated, death.
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 too long, increasingly ineffective, and can be toxic, painful, and costly,” says 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.”