MDGH Update - June 2021

As we celebrated our 15th anniversary, we continued our work on moxidectin, to generate new data to support its introduction into endemic areas, and licensed-in CC-11050 (AMG 634), an investigational treatment for leprosy and tuberculosis. Our 2020 Annual Report documents this progress as well as our current thinking on our contribution to neglected disease R&D and access to medicines.

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We would like to thank the many friends, funders, and partners who continue to help us in our effort to provide the best medicines to those who need them most. Please click here to download our 2020 Annual Report.

Happy reading!

Mark Sullivan,

Managing Director

'Treatment for all': development of a new formulation of moxidectin for children begins

MDGH has commenced development of a new formulation of moxidectin specifically for children unable to swallow the available 2 mg tablet form. In the “MiniMox” project co‑funded by the European and Developing Countries Clinical Trials Partnership (EDCTP), the Luxembourg National Research Fund (LNRF) and MDGH, MDGH and its partners are developing a paediatric formulation aimed at making moxidectin a “treatment for all". The program of work includes developing target product (paediatric formulation) characteristics, conducting a survey in Cameroon of end-user preferences for paediatric medicines and bench-top research and development of suitable formulations, before GMP-grade manufacturing of a selected formulation to be evaluated in a clinical bioequivalence study in Ghana.

The project is coordinated scientifically by MDGH UK, a wholly-owned subsidiary of MDGH Australia, together with the Luxembourg Institute of Health, the financial and administrative coordinator, which together lead a consortium comprising the University of Health and Allied Sciences (Ghana), the University of Strathclyde (UK), the University Hospital Bonn (Germany) and the Centre for Research on Filariasis and other Tropical Diseases (CRFilMT; Cameroon). The project is obtaining technical and scientific advice from the UNICEF / UNDP / World Bank / WHO Special Programme for Research and Training in Tropical Diseases (TDR; Switzerland).

Moxidectin has been approved by the US FDA for treatment of onchocerciasis in those 12 years and older; a clinical study to identify a dose suitable for treatment of children down to 4 years is ongoing. Moxidectin is also in clinical development by MDGH for scabies, a poverty-related disease affecting children in low-, middle- and high-income countries from a very young age, and by Swiss TPH for soil-transmitted helminths and strongyloides, infections prevalent in young children. A new formulation may enable moxidectin to be used to treat younger age groups.

Under the 2019 grant program for paediatric drug formulations for poverty-related diseases, the “MiniMox” consortium has received €2.1M from the EDCTP2 programme and €724,000 from the Luxembourg National Research Fund to co‑fund the development of the new formulation. MDGH will fund the bench-top development work, GMP-grade manufacturing of a selected formulation for the clinical trial and development of an enhanced population pharmacokinetic model of moxidectin in children and adults.

The EDCTP grant for “MiniMox” is running from January 2021 to June 2024.

This project is co-funded by the Luxembourg National Research Fund and MDGH.‍

Moxidectin for onchocerciasis: clinical study updates

MDGH is pleased to announce the start of treatment of the participants in three key clinical trials of moxidectin for onchocerciasis:

• Phase 3b implementation repeat-dose, multi-year study in the Democratic Republic of Congo, DRC (Study MDGH-MOX-3001). The goals of this study are to generate data on the annual and biannual administration of moxidectin and in comparison with ivermectin to inform optimal usage of moxidectin for field use, to achieve label inclusion for repeat dose administration and to inform disease elimination modelling.
• Phase 3b single-dose implementation safety study in DRC (MDGH-MOX-3002). The goal of this study is to generate a body of safety data to support recommendation of moxidectin in onchocerciasis treatment guidelines. The overall objective is to generate additional data for the field to support the use of moxidectin in endemic community treatment programs to accelerate onchocerciasis elimination.
• Moxidectin pharmacokinetic and dose finding study in children 4 to 17 years in Ghana (MDGH-MOX-1006). The overall objective of this study is to generate data in children below 12 years old that would support their inclusion in onchocerciasis treatment programs.

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Moxidectin for scabies: clinical study updates

The objective of the moxidectin for scabies program is to obtain stringent regulatory authority approval for moxidectin as a treatment for scabies in adults and children. Recruitment in the moxidectin for scabies study (MDGH-MOX-2001) continues in Australia and France with a total of 12 patients currently enrolled. This is a Phase 2a, randomised, double-blind, parallel group dose finding study of single oral doses of moxidectin in adults with scabies. A Phase 2b study is expected to begin before the end of 2021.

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Moxidectin for strongyloides: clinical study updates

Data on the use of moxidectin in strongyloides was published in March (Hofmann et al., 2021, The Lancet Infectious Diseases). The Phase 2a study was coordinated by the Swiss Tropical and Public Health Institute and funded by Fondazione Adiuvare. Moxidectin was well tolerated across all treatment groups, with no serious adverse events being recorded and all reported symptoms being classified as mild. The authors concluded that “because 8 mg of moxidectin is used for the treatment of onchocerciasis and has been evaluated for other helminth infections, we recommend this dose for phase 2b and phase 3 trials of strongyloidiasis therapy”. Click to here read more.

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CC-11050 for tuberculosis: clinical study update

An article in The Lancet Respiratory Medicine was published in March by the Aurum Institute and partners with data suggesting that combination therapy with CC-11050 enhances the recovery of FEV1, a key measure of lung function. The study was funded by the Bill & Melinda Gates Foundation and the South African Medical Research Council. Click here to read more.