Kalazar Drug Enters Phase Two Clinical Trials in Ethiopia

Addis Ababa: The Kalazar treatment drug has reached an exciting milestone as it enters the crucial phase two clinical trials in Ethiopia.

This development brings renewed hope for the effective and patient-friendly treatment of Kalazar, also known as visceral leishmaniasis, a disease that poses a significant health challenge in Eastern Africa.

Director of the Kalazar Disease Research and Treatment Center at the University of Gondar, Dr. Samuel Teshome highlighted the significance of this progress and the opportunity it presents for developing a safe and efficient cure for Kalazar in Ethiopia for new cases of the disease has been increasing in the country.

According to him, Kalazar is a parasitic disease that ranks as the second deadliest globally, following malaria. It is characterized by symptoms such as persistent fever, weight loss, and enlargement of the spleen and liver. Without proper treatment, the disease can be fatal, he said.

It is primarily transmitted through the bite of infected sandflies and
is endemic in 80 countries, particularly in Eastern Africa, South Asia, and Latin America.

Dr. Samuel said Eastern Africa currently bears the highest burden of Kalazar cases. Alarmingly, children under the age of 15 accounts for half of the 50,000 to 90,000 new cases reported each year.

The research has been carried out in collaboration with researchers and laboratory institutions of various countries, he pointed out.

The current treatment for Kalazar in Ethiopia involves a 17-day regimen of painful daily injections administered at hospitals, Dr. Samuel said.

However, the newly developed drug, LXE408, offers a promising alternative. According to Dr. Samuel, LXE408 is administered orally in the form of pills, which is expected to provide improved efficacy and safety compared to the existing treatment options. This patient-friendly approach has the potential to revolutionize the way Kalazar is treated, offering a more convenient and accessible solution.

The drug is expected to have high level of curability
with very little side effects which will be available easily in health centers in villages.

Research and Treatment Center (LRTC), co-Principal Investigator of the clinical trial at the Leishmaniasis at the University of Gondar Dr. Eleni Ayele, emphasized the significance of conducting the phase two clinical trial in an endemic country like Ethiopia.

She highlighted the limitations of the current treatment options, which can be potentially toxic, require injections and cold-chain supplies, and often necessitate patients to travel long distances and stay in hospitals for extended periods.

The goal of the research 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, she said.

This approach could significantly reduce morbidity and transmission rates associated with Kalazar, bringing the treatment closer to the affected communities, the researcher added.

The Director of the Leishmaniasis program at the Dru
gs for Neglected Diseases initiative (DNDi), Dr. Fabiana Alves also emphasized that the clinical trial for LXE408 represents a significant step towards delivering better, patient-friendly, and effective medicines that are accessible to all those in need.

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, which involves a diverse range of partners.

This collaboration ensures that the research is well-resourced and supported by various stakeholders, further enhancing its potential impact.

Source: Ethiopian News Agency