First participant enrolled in a Phase 2 clinical trial of dovramilast for leprosy type 2 reaction

Melbourne, Australia

Medicines Development for Global Health (MDGH) today announced the enrolment of the first participant in a multinational Phase 2 clinical trial evaluating a new treatment for leprosy type 2 reaction. The first participant was enrolled in Indonesia at Universitas Gadjah Mada, Yogyakarta.

The Phase 2 study will assess the safety and efficacy of two dose levels of dovramilast, and to compare to the current standard of care treatment. The trial is conducted in the United States, Philippines, Indonesia, Benin, Cote d’Ivoire and Madagascar.

Leprosy type 2 reaction is a complication of leprosy and most commonly occurs in patients who are receiving multidrug therapy for their leprosy, but can occur before treatment or long after treatment is completed. Patients typically suffer greatly, often experiencing fatigue, fevers and painful skin lesions, which can appear on the face and limbs. Consequences in the worst cases can lead to permanent nerve damage, deformities and limb amputation, even death.

Dovramilast, the investigational medicine being evaluated in the study, has been shown in a small clinical trial in Nepal to be well tolerated and all ten leprosy type 2 reaction patients who received 28 days of treatment with dovramilast saw improvement in their symptoms within 7 to 14 days of treatment initiation. Current therapies for leprosy type 2 reaction while effective, often cause significant side effects and may not be suitable for everyone. Given the unmet treatment needs, MDGH hopes to provide a more effetive, better tolerated and easier to administer alternative treatment for people affected by leprosy type 2 reaction.

“This is an important milestone, both for the study and for some of the most disadvantaged people that leprosy type 2 reaction commonly effects, and potentially provides a much needed alternative treatment option.” said Dr Lydia Iannazzo, Dovramilast for leprosy type 2 reaction Project Lead. “We are proud to be partnering with exceptional investigators and research teams to execute this study and make a real difference to people’s quality of life.”

Funding for the study is provided by the Australian Department of Foreign Affairs and Trade through the Partnerships for a Healthy Region initiative, the Anesvad Foundation and the Follereau Foundation as well as a number of Australian family offices trusts and foundations.

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About Medicines Development for Global Health

MDGH is a not-for-profit pharmaceutical company dedicated to the development and supply of new and improved medicines for diseases that disproportionately affect people in low- and middle-income countries.

In 2014, MDGH received a license from WHO (which had initiated and led moxidectin development for onchocerciasis through TDR), for all data at its disposal to support the registration of moxidectin and make it available to endemic countries. In 2018, MDGH achieved United States Food and Drug Administration approval of moxidectin for the treatment of river blindness (onchocerciasis), and is currently developing moxidectin for the treatment of several other neglected tropical diseases.

In 2020, the company assumed full responsibility for the development and commercialisation of dovramilast from Amgen for both tuberculosis and leprosy type 2 reaction.

Further information is available at www.medicinesdevelopment.com

Media Contact

Dr Lydia Iannazzo

Associate Director and Project Leader, Leprosy type 2 reaction

+61 3 9912 2400

news@MDGH.com

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