An update on the progress of our major programs

‍Moxidectin in river blindness (onchocerciasis)

‍Moxidectin was approved by the US Food and Drug Administration in 2018, for the treatment of river blindness in people aged 12 and over. Since then we have been conducting a series of additional clinical trials aimed to facilitate inclusion of moxidectin in World Health Organisation river blindness treatment guidelines.Recent modelling [Kura K et al., 2023, Philos Trans R Soc Lond B Biol Sci] suggests that moxidectin holds the potential to accelerate elimination of transmission of river blindness in areas of moderate endemicity, compared with ivermectin, and may be the only strategy that can achieve elimination in areas of hyperendemicity.A summary of the moxidectin for river blindness clinical studies is shown here:

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Ghana Visit‍

Medicines Development for Global Health team members Barbara Roth (Principal Manager, Medicines Access) and Sophie Weston (Implementation Project Manager) recently returned from Ghana where they observed first-hand the hard work and meticulous planning of the Ghana Health Service Neglected Tropical Diseases Program. Mass Drug Administration (MDA) programs for river blindness and lymphatic filariasis target 6.2 million people across the country in endemic regions for these diseases, and the July 2024 MDA campaign was in full swing.The team participated in multi-level training sessions, a national media briefing, and were able to observe medicine distribution by community distributors. This is a crucial step for us as we prepare for the MOMENTUM pilot field program in partnership with the Ghana Health Service NTD team. The MOMENTUM program will introduce moxidectin, a novel treatment for the community management of river blindness, into the Twifo Atti-Morkwa district of Ghana and is scheduled to start in January 2025.The team also met with WHO AFRO (Africa Regional Office), WHO ADP (Access and Delivery Partnership), the international non-profit implementing partner FHI360 and the health information and clinical research group IQVIA, whose support will be instrumental to the MOMENTUM project’s success. Moxidectin will be the first new treatment for river blindness in 30 years, and this significant stride is only possible through the dedication and collaboration of all our partners.

‍GONE Webinar: Moxidectin Development Update - a promising additional tool to accelerate elimination of onchocerciasis

‍Medicines Development for Global Health recently hosted a webinar organized by secretariat for the Global Onchocerciasis Network for Elimination (GONE) featuring Sally Kinrade, Vice President and Project Leader, Moxidectin for Onchocerciasis and Lymphatic Filariasis (LF). Sally provided an update to the onchocerciasis community on progress of moxidectin towards community use including an update on all studies completed, ongoing, or about to begin since the initial US FDA approval for the treatment of onchocerciasis. The presentation was also delivered in French by Barbara Roth, Principal Market Access Manager and live Q&As were held in both languages. The growing body of evidence for moxidectin in onchocerciasis and LF will contribute to the World Health Organization's recently initiated process of developing treatment guidelines for filarial diseases and will help guide the programmatic use of moxidectin.You can access the webinar here: English and French.

‍Moxidectin in lymphatic filariasis

‍We are investigating the potential of moxidectin-based regimens for the treatment of lymphatic filariasis.  New regimens are particularly important for communities in much of sub-Saharan Africa where “gold standard” diethylcarbamazine combinations cannot be used due to safety concerns. An alternative treatment with comparable efficacy to diethylcarbamazine combinations but without the safety risks is greatly needed to ensure these areas are not left behind.A recently completed Phase 2 study sponsored by the Death to Onchocerciasis and Lymphatic Filariasis (DOLF) project led by the University of Washington at St Louis presented promising top-line results after 12- and 24-months follow-up at each of the last two American Society of Tropical Medicine and Hygiene conferences held in Seattle and Chicago, with the final 36 month results anticipated soon. A Phase 3 study to evaluate the safety and efficacy of moxidectin combination regimens compared with ivermectin, diethylcarbamazine and albendazole (IDA) for LF outside of Africa is planned for 2025.A summary of the status of our moxidectin for lymphatic filariasis clinical studies is shown here.

Moxidectin in scabies

‍Our Phase 2b clinical study (MDGH-MOX-2002) investigating the use of moxidectin as a single dose oral treatment for scabies is underway, with enrolment approaching completion. Current treatments for scabies are either cumbersome topical medications, or multi-dose oral treatments.A summary of the status of our moxidectin for scabies clinical studies is shown here.

Study MDGH-MOX-2002 has now enrolled over 180 patients from sites in the United States, Honduras, the Dominican Republic and El Salvador. Atticus Medical is supporting this study which is sponsored by Medicines Development for Global Health.Earlier this year, Dr Victoria Ryg-Cornejo, Project Leader for the scabies program, visited clinical trial sites in Honduras, Dominican Republic, Puerto Rico and the United States to gain a first-hand look at the study progress.“It has been really encouraging to see the clinical teams’ commitment to this study because it would not be possible to develop what we expect to be an easier, simpler option to treat scabies, without them”, commented Dr Ryg-Cornejo. “We knew our investigational teams were enthusiastic about this study and the potential of moxidectin, and it’s such a great experience to see how it’s fuelling team efforts to enrol scabies patients”. Victoria is shown here meeting with one of the study Investigators, Dr Elizabeth Barranco and her team at CAIMED Center, Ponce Research Institute, Puerto Rico.According to the World Health Organization, over 200 million people worldwide are affected by scabies at any given time. It is particularly common in hot, tropical countries and in areas of high population density where it spreads readily through skin-to-skin contact. In settings like these, the prevalence among children can reach 50%. One of the biggest challenges for treatment is that it often requires repeat administration of topical creams or oral medications. We are investigating the potential for moxidectin as a single-dose oral treatment for human scabies.

‍Dovramilast in leprosy type 2 reaction, and tuberculosis

‍There is an urgent unmet need to replace thalidomide or prolonged corticosteroid therapy, both of which have significant side effects, for the treatment of leprosy type 2 reaction.Our Phase 2 program for dovramilast (formerly CC-11050, AMG 634) for the treatment of leprosy type 2 reaction is underway with one study active and the other in planning. Step 2 of the dovramilast study in Nepalese patients with leprosy type 2 reaction (IIS-CC1-2001), supported by MDGH, and sponsored by the Leprosy Mission Nepal has commenced. Work is also underway to prepare for our Phase 2b dose ranging safety and efficacy study of dovramilast in adults with moderate to severe acute or recurrent leprosy type 2 reaction (MDGH-DOV-2001).The clinical trial of dovramilast in tuberculosis (TB), supported by MDGH, and conducted by the Aurum Institute in Africa and Europe, has recruited over 200 participants so far. We are actively engaging with stakeholders in this space and are eagerly awaiting the results of this study to help us fully understand the potential of dovramilast in TB.A summary of the status of our dovramilast for tuberculosis and leprosy type 2 reaction clinical studies is shown here:

We thank all of the investigators, their teams and our partners who have helped us accomplish these milestones, and we are grateful to you for your continued support.

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