A global clinical trial to establish the efficacy of a potential drug to treat visceral leishmaniasis (commonly known as Kala Azar in India) will be carried out predominantly in India in 2021 with additional trials in Africa.

The Pharma major Novartis and the Drugs for Neglected Diseases initiative (DND i ) , a not-for-profit research and development (R&D) organisation, headquartered in Geneva, 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.

DNDi will lead the phase 2 & 3 clinical development. LXE408 is 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 trials. In addition, it 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 to endemic areas.

India has a National Kala Azar elimination programme going. The DNDi, India has supported it by strengthening the capacity of five health care facilities in Bihar (Purnia, Saharsa, Saran, Vaishali and Mauzzafarpur District Hospitals) to conduct parasitological diagnosis of visceral leishmaniasis.

“Existing treatments for visceral leishmaniasis are simply not good enough. They are too long, increasingly ineffective, and can be toxic, painful, and costly,” said Bernard Pécoul, Executive Director of DND i . “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,” he said in a statement.

Over one billion people worldwide are at risk of leishmaniasis, which is transmitted by the bite of a sand fly. 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.

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. In India, it is endemic in Bihar.

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