Medicines Development for Global Health receives U.S. FDA clearance of Investigational New Drug Application for dovramilast in leprosy type 2 reaction

Melbourne, Australia

Medicines Development for Global Health (MDGH) today announced that the United States Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) Application for dovramilast and its global Phase 2 clinical trial may proceed in the United States to assess dovramilast in people with acute or recurrent leprosy type 2 reaction. The study is expected to begin by the end of Q3 2025, with sites in the United States, Philippines, Indonesia, Côte d'Ivoire, Benin and Madagascar.

Leprosy type 2 reaction is a debilitating and disfiguring immune reaction that can arise as a complication of leprosy infection. According to the World Health Organization, approximately 175,000 new cases of leprosy are reported each year. A subset of patients diagnosed with leprosy will develop leprosy type 2 reaction. Consequences can be long lasting, in the worst cases leading to permanent nerve damage, deformities and potentially limb amputation. 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.

Current treatments for leprosy type 2 reaction rely on prolonged use of anti-inflammatory and immunosuppressive medicines such as prednisolone, which is associated with significant side-effects, and thalidomide, whose use is highly restricted and is not recommended in women of child-bearing potential unless stringent pregnancy prevention measures are adhered to due to its potential to cause foetal abnormalities. This underscores the need for new potential medicines like dovramilast, a phosphodiesterase type 4 (PDE4) inhibitor.

This milestone is another step forward in the development of dovramilast, a potential new oral treatment option for individuals suffering from leprosy type 2 reaction.

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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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