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Newsletter volume 5. December 2021.
Dear <<First Name>>

Welcome to our Q4 2021 Newsletter, highlighting the latest activities for Medicines Development for Global Health.
Preliminary Lymphatic Filariasis data for moxidectin presented
Encouraging preliminary safety and efficacy data from the first clinical trial evaluating moxidectin as a potential treatment option for lymphatic filariasis was presented at this year’s American Society of Tropical Medicine & Hygiene (ASTMH) annual meeting in Washington, D.C. The study, sponsored and conducted by the Washington University in St. Louis, USA Death to Onchocerciasis and Lymphatic Filariasis (DOLF) Project, assessed the combination of moxidectin and albendazole or ivermectin and albendazole with or without diethylcarbamazine. The study being conducted in Cote D’Ivoire will continue over two further years. This DOLF project is supported by the Bill and Melinda Gates Foundation.

Although the data are preliminary and the analysis was of a small subset of the study population, moxidectin combination therapies were well tolerated and the efficacy observed warrants further evaluation. For more information on the study, please click here.

MDGH is now evaluating the development pathway for moxidectin in treatment of lymphatic filariasis.
Progress towards identifying an optimal dose of moxidectin for treating children with onchocerciasis
MDGH continues its efforts to generate the additional post-approval data needed for inclusion of WHO treatment guidelines for river blindness, the need for an effective dose to treat at risk younger children remains.
 
Towards that objective, MDGH is conducting a dose finding (pharmacokinetics and safety) study of a single oral dose of moxidectin in subjects aged 4 to 17 years with (or at risk of) onchocerciasis. The primary objective of the study is to identify an optimal dose for treatment of children 4 to 11 years. The study is being conducted at the School of Public Health, University of Health and Allied Sciences (UHAS) Research Centre, formerly the Onchocerciasis Chemotherapy Research Centre (OCRC) research facility, Hohoe, Ghana.
 
Safety is core element of any clinical trial. This study is designed to use population pharmacokinetic (popPK) modelling to minimise the number of children and the number of invasive procedures for each child. To balance risks in study participation with potential individual benefit of treatment, participants are being recruited from an area where onchocerciasis is endemic. The study is approved by institutional and national research ethics committees in Ghana, the Ghana Food and Drug Administration, the US Food and Drug Administration and the World Health Organisation research ethics committee.
 
On behalf of the Principal Investigator Dr Nicholas Opoku at UHAS, Sally Kinrade, Vice President and Project Leader for Onchocerciasis and Lymphatic Filariasis at MDGH, presented preliminary results from this study during the ASTMH 2021 annual meeting on 19 November 2021. Safety and pharmacokinetic data from two out of the three age cohorts in the study have been analysed and these data included in the popPK model. The results of the completed study, supported by the data available from adults, will underpin an application to extend moxidectin’s use to include the treatment of children aged 4 to 11 years old.
 
This clinical study is sponsored and funded by MDGH and forms part of a broader project supported by grant funding from the European and Developing Countries Clinical Trials Partnership, EDCTP2.
This project is part of the EDCTP2 programme (Grant RIA2019PD-2880 - MoxiMultiDoseMod) supported by the European Union.
Update on the development of a paediatric formulation of moxidectin
The project to develop a paediatric formulation of moxidectin is nearing completion of its first year of activity. In the past 11 months, target product characteristics for a paediatric formulation of moxidectin was developed and endorsed by project partners. Professor Hannah Batchelor from the University of Strathclyde commenced research and development work in May to formulate two different types of formulation to meet the desired characteristics of suitability for very young children. These formulations have been developed and manufactured at small-scale under laboratory conditions, and the project team are now testing these and assessing their stability over time.

In parallel to this, Professor Joseph Kamgno and his team in Cameroon have been conducting community-based surveys of community drug distributors, children aged three to 12 years of age and their caregivers and other key members of the community. The objective of their study is to assess end-user preferences in medicines used to treat young children. Two of a total of four field sites have been surveyed so far with a third to be completed by the end of this year. The outcomes of Professor Batchelor’s development work and Professor Kamgno’s community surveys, will inform final selection of a formulation to be manufactured under international standards of manufacture (‘Good Manufacturing Practice’)  conditions for use as clinical trial material for a relative bioavailability study. This study is planned to compare the paediatric formulation with the approved 2 mg tablet formulation of moxidectin.

The “MiniMox” project is co-funded by the EDCTP, the Luxembourg National Research Fund and MDGH. It involves MDGH UK, a wholly-owned subsidiary of MDGH Australia, the Luxembourg Institute of Health, 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 (Switzerland).
This project is part of the EDCTP2 programme (grant RIA2019PD-2880-MiniMox) supported by the European Union. It is co-funded by the Luxembourg National Research Fund, EDCTP, and MDGH.
MDGH UK Board of Directors
New MDGH UK Board Directors Dr Michael Elliott (L) and Professor Andrew Wilks (R)
MDGH first established a legal entity in the United Kingdom in 2015 called Medicines Development for Global Health Limited. The UK company recently appointed two additional Directors. Dr Michael Elliott (FRCP), Vice President of Australia, Canada, Europe Medical Affairs at Gilead Sciences in London and Professor Andrew Wilks (FTSE FAHMS) Co-Founder and Executive Chairman of SYNthesis Med Chem, join the existing members of MDGH Limited Board of Directors Dr. Lorna Meldrum (Board Chair), Mark Sullivan, and Kate Antrobus (Chief Investment Officer at Univercells).

Dr Elliott has more than thirty years of pharmaceutical industry experience following six years in hospital medical practice. Prior to his current role as Vice President Medical Affairs at Gilead Sciences, Dr Elliott was Vice President and Medical Director at GlaxoSmithKline Asia Pacific for 10 years. Michael brings a wide range of global experience in medicine development, commercialisation, governance, and strategy. He led global development programmes of early-stage and late-stage compounds and has worked within the local operations divisions of a UK company (SB) and US companies (Schering-Plough, GSK) as well as within global R&D. For nine years, Michael has held his leadership role with Gilead Sciences during an accelerated growth phase which has included expansion and twelve launches of novel medicines for HIV, Viral Hepatitis and Haematology/Oncology indications. Michael has a diploma in Pharmaceutical Medicine UK, holds an MBA and is a graduate of the Australian Institute of Company Directors.

Professor Wilks is a serial entrepreneur with 25 years of industry experience, following a highly successful academic career as a cancer researcher at the Ludwig Institute for Cancer Research. He founded Cytopia in 1997, one of Australia’s earliest Australian Stock Exchange-listed drug discovery companies. Since then, he has founded eleven companies in the drug discovery arena. He was co-founder of SYNthesis med chem, a global contract research organisation with laboratories in China, and SYNthesis Research, a ‘venture-discovery’ company that funds and manages drug discovery collaborations generated from academia. Andrew holds an Adjunct Professorship at Monash University, and is an Honorary Enterprise Professor at the University of Melbourne. He is an elected Fellow of the Australian Academy of Technology and Engineering and of the Australian Academy of Health and Medical Sciences. He has received a number of awards including the JNJ Ausbiotech Industry Leadership Award, the ATSE Clunies Ross Medal, and the Lackmann Award for Translational Research.
Eureka Prize winner - Professor Julie Bines
Professor Julie Bines (front row, second from left), recipient of this year's Eureka Prize for Infectious Disease Research, and her team. (Photo credit: Amanda Handley/MDGH)
This year’s Eureka Prize for Infectious Disease Research was awarded to Professor Julie Bines, Murdoch Children’s Research Institute and University of Melbourne, for her work leading the development of a new rotavirus vaccine for newborns. RV3-BB is a vaccine being developed to prevent rotavirus gastroenteritis from birth, potentially saving thousands of lives. MDGH’s Amanda Handley continues to work with Professor Bines’ development team providing development management expertise to the group.
 
The Australian Museum Eureka Prizes are the country’s most comprehensive national science awards, honouring excellence across the areas of research and innovation, leadership, science engagement, and school science. Presented annually in partnership with some of the nation's leading scientific institutions, government organisations, universities and corporations, the Eureka Prizes raise the profile of science and science engagement in the community by celebrating outstanding achievement.
 
MDGH congratulates Professor Bines on her award.
MDGH engages with Global Institute for Disease Elimination, and Bridges to Development
MDGH is now working with the Global Institute for Disease Elimination on moxidectin communication and implementation. The Global Institute for Disease Elimination, based in Abu Dhabi, has been established through a partnership between His Highness Sheikh Mohamed bin Zayed Al Nahyan, The Crown Prince of Abu Dhabi, and the Bill & Melinda Gates Foundation. The Institute is working with MDGH on a series of engagement and advisory meetings to provide technical and organisational support.

MDGH has also engaged with Bridges to Development, a non-profit founded in 2018 based in Europe and the US, that “strives to build on the world's significant progress to date towards a stronger and more resilient future.” MDGH is working with the team at Bridges to Development to assist with implementation planning for moxidectin.
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