OneWorld Health Safety and Efficacy Study of Kala-Azar Treatment in Bangladesh Moves Forward

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--OneWorld Health (OWH), a non-profit organization dedicated to developing lifesaving medicines for neglected diseases in children, announced completion of enrollment for an effectiveness study of Paromomycin Intramuscular Injection (PMIM) as a treatment for visceral leishmaniasis (VL or kala-azar) in Bangladesh. With 120 patients enrolled, the study is investigating the safety and efficacy of treatment of kala-azar with PMIM mono-therapy in VL-endemic areas of the country.

“We look forward to working together with our regional partners, and leveraging our expertise in visceral leishmaniasis to deliver impactful results to a great number of people in need.”

With approximately 500,000 new cases occurring annually, kala-azar is the world’s second most deadly parasitic disease after malaria. Fatal if untreated, the official death toll for VL each year is between 50,000 and 60,000. VL is endemic in 65 countries, and primarily afflicts rural, resource-poor populations in India, Nepal, Bangladesh, Sudan and Brazil, where affordable therapies are needed.

Working with researchers who are experts in the treatment of kala-azar, and scientists at the Centre for Communicable Diseases, icddr,b (an international public health research institution based in Dhaka), OWH’s effectiveness study is gathering information on how safe and efficacious PMIM mono-therapy for VL is on a regional level, as well as its feasibility in the government health system in Bangladesh. By conducting clinical trials at sites that are removed from urban centers, the study will also contribute to local capacity building for research and treatment of this deadly disease.

“This is an innovative model for administering PMIM using an outpatient setting to diagnose and treat impoverished patients, inclusive of a 6-month follow-up, in the remote areas where VL is endemic. We adopted a similar model for the trials in India, and now are working to advance this treatment to Bangladesh,” said Dr. Raj Shankar Ghosh, OWH’s VP and Head of South Asia. “We look forward to working together with our regional partners, and leveraging our expertise in visceral leishmaniasis to deliver impactful results to a great number of people in need.”

The study in Bangladesh follows on the success of OneWorld Health’s Phase 3 and Phase 4 clinical studies in India, which established PMIM as a safe, effective, and affordable treatment for VL in the country.

About kala-azar (VL)

Kala-azar, or VL, is a potentially fatal infectious disease that is transmitted through the bite of a sandfly and affects visceral organs (e.g., enlargement of spleen and liver), causing chronic fever, weight loss and anemia. VL is endemic in 65 countries, primarily in the developing world, and the population at risk is estimated at 200 million. The disease often strikes impoverished populations living in rural villages that may not be able to afford the treatments currently available. If left untreated, VL is nearly always fatal. Officially, VL causes 50,000 to 60,000 deaths every year.

About Paromomycin Intramuscular Injection

An off-patent aminoglycoside antibiotic, paromomycin is an established drug with an extensive history of use and well-characterized safety profile. OneWorld Health developed Paromomycin Intramuscular Injection (PMIM) as an effective, inexpensive and safe treatment for VL, and worked with the Indian Government and Indian pharmaceutical company Gland Pharma to manufacture and distribute the treatment. PMIM received regulatory approval by the Drug Controller General in India, has been designated for the WHO’s Model List of Essential Medicines, and was included in Essential Drug Lists of Nepal and Bangladesh. PMIM is administered as a once-a-day injection for 21 days. The cost of a course of treatment with PMIM is less than US$20, which is significantly lower than other currently approved VL therapies.

About OneWorld Health

Headquartered in South San Francisco, OneWorld Health is a non-profit research and development organization that discovers, develops and delivers safe, effective and affordable new treatments and interventions for impoverished patients, especially children, suffering from neglected diseases in the developing world. More information can be found here: www.oneworldhealth.org.