Medicines Development for Global Health submits an Investigational New Drug Application for dovramilast for the treatment of leprosy type 2 reaction

Melbourne, Australia

Medicines Development for Global Health (MDGH) is pleased to announce that it has submitted an Investigational New Drug (IND) application for dovramilast, a potential breakthrough treatment for leprosy type 2 reaction, to the United States Food and Drug Administration (U.S. FDA).

The IND submission to the FDA marks a significant milestone in MDGH’s mission to address neglected diseases and improve global health outcomes. Leprosy type 2 reaction is a debilitating and disfiguring immune reaction that can occur as a consequence of a leprosy infection. Based on the most recent numbers released by the World Health Organization in 2022, there are about 175,000 new cases of leprosy each year and more than 50,000 of these people will go on to have this debilitating reaction, not to mention those already afflicted.

The submission of the IND application precedes the initiation of MDGH’s first dovramilast clinical trial at sites in the U.S., Indonesia, Philippines, Benin, Cote d’Ivoire and Madagascar, and brings us one step closer to providing a new effective and accessible oral treatment option for individuals suffering from leprosy type 2 reaction.

"Submitting the IND application to the FDA is a significant achievement for MDGH and a testament to our continuing commitment to addressing neglected diseases," said Dr Danielle Smith, Global Head of Regulatory Affairs at MDGH.

"Having recently seen firsthand the devastating consequences these leprosy type 2 reactions and the current treatments have on people is heartbreaking and reinforces my commitment to working with our team to develop a treatment that can help them. The IND submission is the first step to achieving this goal" added dovramilast for leprosy type 2 reaction Project Lead, Dr Lydia Iannazzo.

MDGH’s efforts to develop dovramilast as a treatment for leprosy type 2 reaction align with its core mission to improve global health equity. The submission of the IND application brings hope to tens of thousands of people suffering from leprosy type reaction, a disease that has often been overlooked in the past.

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About Medicines Development for Global Health

MDGH is a not-for-profit pharmaceutical company dedicated to the development and delivery of new and improved medicines for diseases that disproportionately affect people in low- and middle-income countries. In 2020, the company assumed full responsibility for the development and commercialisation of dovramilast from Amgen 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 and dovramilast

Leprosy is a neglected tropical disease caused by infection with Mycobacterium leprae. MDGH is developing dovramilast, a phosphodiesterase 4 inhibitor, as a potential treatment for leprosy type 2 reaction (erythema nodosum leprosum), 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 current management of leprosy type 2 reaction requires prolonged treatment with anti-inflammatory and immunosuppressive drugs such as prednisolone and/or thalidomide, both of which can add to the existing disease burden, highlighting the need for the development of new treatments, such as dovramilast.

The dovramilast program is supported by:

- The Australian Government

- 15 Australian family offices, trusts and foundations

- Amgen, Inc.

- Lonza, Inc.

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