DNDi, partners launch 2nd VL medicine clinical trial

ADDIS ABABA –A second phase clinical trial designed to develop safer, simpler and patient-friendly oral medicine to treat Visceral Leishmaniasis (VL) has been launched in Ethiopia.

The study, which is being conducted by Drugs for Neglected Diseases Initiative (DNDi) and its partners aimed at reducing the side effects and the pain patients sustain while taking the existing VL medicine – an injection given at hospital daily for 17 days, a treatment that may also present rare but life-threatening side effects, including to the heart, liver and pancreas, according to a press release sent to The Ethiopian Herald indicated.

In contrast, DNDi said in the statement that the new molecule under study in Ethiopia, called “LXE408”, is administered in the form of oral pills and is expected to be safer than the current treatment.

“This is very significant that Ethiopia, an endemic country, is conducting a Phase II clinical trial on a new chemical entity — a novel molecule with the potential to safely and effectively treat visceral leishmaniasis,” said Eleni Ayele (MD), the clinical trial co-Principal Investigatorat University of Gondar, Leishmaniasis Research and Treatment Center (LRTC).

She stated in the release that the current treatment options in Ethiopia have severe limitations as they are potentially toxic, necessitate injections and cold-chain supplies, and require patients to travel to faraway hospitals to be hospitalized for long periods.

“Our hope is that this new oral treatment will be efficacious and less toxic and can be given to patients at the primary healthcare level, close to their homes,” Eleni said.

This would help the patients to access treatment earlier, which could significantly decrease morbidity and transmission, she said, adding that if the trial is successful, it could go a long way toward enabling the sustainable elimination of this terrible disease.

The molecule is tested alongside the standard of care in Ethiopia and 52 adults from 18 to 44 years will join the study, according to the statement.

“We are moving towards a new generation of treatments for leishmaniasis. Finding new treatments is key if we want to sustainably eliminate visceral leishmaniasis in all parts of the world, including in African countries where the burden remains high. We need medical innovation,” said Fabiana Alves (MD), Director of Leishmaniasis Programme at DNDi.

“We hope this new clinical trial will contribute to deliver better, patient-friendly, effective medicines that are accessible to everyone, with no exception.”

Also known as kala-azar, visceral leishmaniasis is the world’s deadliest parasitic killer after malaria. It causes fever, weight loss, spleen and liver enlargement, and, if not treated, death. Kala-azar is transmitted by the bite of infected sandflies and is endemic in 80 countries, mainly in Eastern Africa, South Asia, and Latin America. An estimated 50,000 to 90,000 new cases occur worldwide annually, and half are children under 15.

The clinical trial in Ethiopia is financially supported by the European and Developing Countries Clinical Trials Partnership (EDCPT), as part of the VL-INNO project, bringing together a wide range of partners.



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