MDGH starts its Phase 2 clinical trial of dovramilast in people with leprosy type 2 reaction

Melbourne, Australia

Medicines Development for Global Health (MDGH) announced today, on World Neglected Tropical Disease Day, that its first clinical site is now open and ready to begin recruiting participants in a Phase 2 clinical study testing dovramilast as a possible new treatment for people with type 2 leprosy reaction.

This multi-national, open-label, randomized study (protocol number MDGH‑DOV‑2001; NCT07172659) will evaluate the efficacy and safety of 100mg or 150mg of dovramilast compared with standard of care in adults with moderate to severe acute or recurrent leprosy type 2 reaction. The study will evaluate the signs and symptoms of leprosy type 2 reaction, including skin lesions. Approximately 45 people will take part, with sites open or soon to open in the Philippines, Indonesia, Benin, Côte d'Ivoire, Madagascar, and the United States.

Leprosy type 2 reaction is a debilitating inflammatory condition that occurs as a complication of leprosy, even long after the leprosy infection has been successfully treated. Patients typically suffer with pain, fatigue, fever and painful skin lesions. In the worst cases, this can lead to permanent nerve damage, deformities and limb amputation, and even death. The disease can be disfiguring, resulting in stigma that impacts the sufferer’s ability to attend school or work, and provide and care for their family. This only compounding the challenges already faced by the disadvantaged people that leprosy commonly affects.

Current therapies for leprosy type 2 reaction, while effective, can cause significant side effects and are not suitable for everyone.¹ Prednisolone, a steroid, requires prolonged use and is linked to damaging steroid-related side effects. Thalidomide is subject to strict regulatory controls because of its known impact on unborn children, necessitating comprehensive pregnancy prevention and monitoring programs.

Dr Jane Fisher, Director of Clinical Operations, MDGH, said:

“Leprosy type 2 reaction disproportionately affects patients in underserved communities and has long had limited treatment options. This study marks a meaningful step toward change, advancing new therapeutic possibilities that have the potential to reduce suffering and bring lasting improvements to patients’ quality of life.”

Dr Belen Dofitas, Chief, Division of Complex Wounds, Department of Dermatology, Philippine General Hospital, said:

“Leprosy is curable, but the most challenging complication is lepra reaction even after the infection has cleared. The immune reaction to bacterial antigens not only destroys the skin and nerves but leads to disabilities, despair, and prolonged suffering of our patients. For too long, lepra reaction treatments have been neglected. We need better treatments for leprosy-related nerve inflammation, recurrent and chronic erythema nodosum leprosum. We need affordable and accessible medications now. Investment in lepra reaction research is imperative.”

Dr Lydia Iannazzo, Project Leader, Leprosy type 2 reaction, MDGH, said:

“Having met people suffering from leprosy type 2 reaction underscored for me how urgently better medicines are needed for this devastatingly debilitating disease. This clinical study is the first step towards development of a new treatment that has the potential to improve the lives of those suffering from leprosy type 2 reaction.”

MDGH’s development of dovramilast as a treatment for leprosy type 2 reaction align with its core vision for unlocking global health equity through accessible, innovative medicines. This milestone is a major step forward in the development of new treatment options for individuals affected with neglected tropical diseases.

MDGH acknowledges the funding support of many partners, including, Amgen Inc, the Partnerships for a Health Region program of the Australian Government, Lonza, Inc. and 15 family offices, trusts and foundations.

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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 Africa, 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.

About Medicines Development for Global Health

MedicinesDevelopment 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

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Media Contact

Dr Jane Fisher

+61 3 9912 2400

news@MDGH.com

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