Phase 2 Clinical Trial Begins in Ethiopia for New Oral Drug Targeting Deadly Kala-Azar Disease

A promising new oral drug called LXE408 has entered Phase II clinical trials in Ethiopia to treat visceral leishmaniasis, also known as kala-azar, a deadly parasitic disease transmitted by infected sandflies. The disease has the highest burden in Eastern Africa, South Asia, and Latin America.

The current treatment for kala-azar in Africa involves painful daily injections for 17 days, which can have severe side effects. In contrast, the new oral drug LXE408 is expected to be safer and more patient-friendly. "The new molecule has the potential to transform treatment for this deeply neglected and hard-to-treat disease, as the Eastern Africa region charts the way to its elimination," said a spokesperson for the Drugs for Neglected Diseases initiative (DNDi), which is conducting the Phase II trial in Ethiopia along with its partners.

The goal is to develop an oral treatment that is both efficacious and less toxic, allowing patients to receive care at primary healthcare facilities near their homes. This could significantly reduce morbidity and transmission rates associated with kala-azar. The clinical trial in Ethiopia represents a significant step towards delivering better, patient-friendly, and effective medicines that are accessible to all those in need.

Why this matters: The development of LXE408 brings renewed hope for the effective and patient-friendly treatment of visceral leishmaniasis, a significant health challenge in Eastern Africa. If successful, this oral drug could contribute significantly to the goal of eliminating kala-azar as a public health problem by 2030.

The Phase II clinical trial is being conducted in collaboration with researchers and laboratory institutions from various countries, with financial support from the European and Developing Countries Clinical Trials Partnership (EDCTP). "The Kalazar treatment drug, LXE408, has reached the critical phase two clinical trials in Ethiopia, offering improved efficacy and safety compared to the existing treatment options, which involve painful daily injections," stated a lead researcher involved in the trial. The development of LXE408 was initially supported by Wellcome and is now a collaboration between DNDi and Novartis, with Novartis responsible for further development and potential distribution of the drug on an affordable basis.

Key Takeaways

• New oral drug LXE408 enters Phase II trials to treat visceral leishmaniasis in Ethiopia.
• Current treatment involves painful daily injections; LXE408 aims to be safer and more patient-friendly.
• LXE408 development is a collaboration between DNDi and Novartis, supported by Wellcome.
• Successful LXE408 could contribute to eliminating kala-azar as a public health problem by 2030.
• Phase II trial in Ethiopia is funded by the European and Developing Countries Clinical Trials Partnership.