Patients across Southeast Asia, Africa, and the United States will be among the first in the world to trial a new Australian-developed treatment for a devastating reaction to leprosy, offering the potential for life-changing care without the severe side effects of existing therapies.
Announced on World Neglected Tropical Disease Day, the trial involving leprosy type 2 reaction patients will occur in the Philippines, Indonesia, Benin, Côte d'Ivoire, Madagascar and the United States.
The tablet to be trialled is Dovramilast which is developed by Melbourne-based not-for-profit pharmaceutical company Medicines Development for Global Health (MDGH).
Leprosy type 2 reaction is a debilitating inflammatory condition that occurs as a complication of leprosy. Patients typically suffer from pain, fatigue, fever and painful skin lesions, which in severe cases can lead to permanent nerve damage, deformities, limb amputation and death.
Director of MDGH’s Clinical Operations, Dr Jane Fisher, said leprosy type 2 reaction continues to disproportionately affect people in underserved communities where treatment options have remained limited for decades.
“This study advances a new therapeutic approach which has the potential to reduce suffering and deliver lasting improvements in patients’ quality of life,” Dr Fisher said.
“Beyond the physical pain of skin lesions and fever, leprosy type 2 reaction can cause devastating disfigurement and stigma that isolates people from education, work and community life.
“These impacts compound existing disadvantages and make the need for better treatments especially urgent.”
MDGH Project Leader for leprosy type 2 reaction, Dr Lydia Iannazzo, said meeting people living with this leprosy type 2 reaction made it clear how debilitating this disease is.
“This study is a big step toward developing a treatment which can significantly improve the lives of those who are suffering,” Dr Iannazzo said.
Current therapies for leprosy type 2 reactions can cause significant side effects and are not suitable for everyone. Prednisolone, a steroid, requires prolonged use and is linked to damaging steroid-related side effects, while Thalidomide is subject to strict regulatory controls because of its known impact on unborn children.
The trial across Africa, Southeast Asia and the United States will compare the safety and effectiveness of two oral doses of Dovramilast against standard treatments and encompass around 45 adults with moderate to severe or recurrent leprosy type 2 reaction.
MDGH wishes to acknowledge the funding support of many partners, including Amgen Inc, the Australian Government, Lonza, Inc. and 15 family offices, trusts and foundations.
About Medicines Development for Global Health
Medicines Development for Global Health (MDGH) is a not-for-profit pharmaceutical company, developing medicines to ease the burden of neglected diseases on many of the world’s most disadvantaged people and communities. In 2020, the company assumed full responsibility for the development and commercialisation of dovramilast from Amgen, Inc for both tuberculosis and leprosy type 2 reaction.
For more information about MDGH and its mission to combat neglected diseases, please visit www.medicinesdevelopment.com
About leprosy type 2 reaction
Leprosy is a neglected tropical disease caused by infection with Mycobacterium leprae or Mycobacterium lepromatosis. Leprosy type 2 reaction, also known as erythema nodosum leprosum, is an immune-mediated condition affecting people with multibacillary leprosy.
Commonly characterised by the presence of inflamed and painful skin nodules, leprosy type 2 reaction is actually a multisystem disorder and it can be sufficiently serious to require prolonged hospitalisation. Patients with leprosy type 2 reaction are, in general, chronically ill and fatigued, feverish, in pain and suffering from insomnia, and can also experience painful inflammation in multiple systems or organs. Consequences of recurrent leprosy type 2 reaction may be serious and long lasting, in the worst cases leading to permanent nerve damage and deformities. The disease causes stigma and can impact on a sufferer's ability to attend school, or work and provide for and care for their family. Leprosy type 2 reaction occurs wherever leprosy occurs, and mostly commonly in Nepal, India, South East Asia, central America, and Asia Pacific.
About Dovramilast
Dovramilast, a phosphodiesterase 4 (PDE-4) inhibitor, is an investigational medicine that is not approved for human use anywhere in the world. It is being studied as a potential treatment for leprosy type 2 reaction (also known as erythema nodosum leprosum) for TB in Phase 2 clinical studies.
Dovramilast is in development and not yet approved for treatment in leprosy type 2 reaction in any country.
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