MDGH timeline
MDGH is developing two medicines: moxidectin and dovramilast (AMG 634). Together, these medicines are targeting seven different diseases that collectively have a global prevalence of three billion cases.
2005
MDGH founded as Medicines Development Limited.
2006
Phase 2 study in Ghana begins for Moxidectin in river blindness driven by the WHO, Wyeth and partners.
2007
Discussions with EMA on Phase 3 moxidectin in river blindness.
2009
Phase 2 study in Ghana is completed.
Pfizer acquires Wyeth.
2010
US FDA grants orphan drug designation to moxidectin for river blindness.
2011
Pfizer withdraws from WHO/TDR collaboration. New partner sought.
2013
MDGH approaches WHO/TDR for licensing moxidectin.
2014
Moxidectin licence transferred to MDGH.
2015
MDGH affiliate office in the UK is established.
GHIF commits US$13M in initial funding to support the manufacture of moxidectin.
2016
Pre-NDA meeting with FDA.
2017
C-QT study and CMC finalised.
NDA filed with FDA.
Receipt of AUD$0.45M impact investment loan to bridge cash flow constraints.
2018
FDA approval of moxidectin for river blindness and PRV received.
Founder and Managing Director Mark Sullivan is named 2019 Victorian Australian of the Year.
MDGH awarded the 2018 AusBiotech and J&J Innovation Industry Excellence Award.
2019
MDGH named one of Fast Company’s ‘World’s Most Innovative Companies’ for 2019.
MDGH sells its PRV to Novo Nordisk, with funds raised going towards additional moxidectin clinical trials and field implementation.
€4.6M awarded by EDCTP to a consortium for a paediatric dose finding project that includes MDGH in a key role.
Mark Sullivan recognised as EV’s ‘Entrepreneur of the Year’ in the category of Australian Social Entrepreneur.
Atticus Medical Pty Ltd established as the commercialisation entity to develop moxidectin for indications with large market potential.
2020
MDGH initiates a Phase 2a moxidectin dose-finding study in people with scabies in Australia and France.
2020 Mitchell Humanitarian Award presented to Mark Sullivan and John Reeder.
MDGH and GHIF sign a ‘Development Commercialisation Agreement’ and an ‘IP Management Agreement’.
Results of a Phase 2 clinical trial show that moxidectin is effective and well-tolerated for the treatment of whipworm in adolescents.
Mark Sullivan recognised by the Australian Academy of Technology and Engineering with the Clunies Ross Entrepreneur of the Year Award.
Moxidectin nominated in ‘Best Pharmaceutical Product’ category for the 2020 Prix Galien USA Awards.
MDGH licences a new molecule, dovramilast (CC-11050; AMG 634), from Amgen to advance development as a potential treatment for tuberculosis and leprosy.
2021
A project partially funded by an EDCTP €2.8M grant to a consortium starts. The project's aim is to develop a paediatric formulation of moxidectin for neglected diseases.
An article in The Lancet Respiratory Medicine is published by Aurum Institute and partners and suggests that combination therapy with dovramilast might enhance the recovery of FEV1, a key measure of lung function.
2022
MDGH receives US$4.9M grant for moxidectin programs from the Bill & Melinda Gates Foundation
6+ Invitations to speak to key international meetings (Kigali Summit on Malaria and Neglected Tropical Diseases, American Society of Tropical Medicine and Hygiene, World Health Organization Onchocerciasis Technical Subcommittee, World Health Organization Global Accelerator for Paediatric Formulations Network, COR- NTD, etc.)
Preclinical proof of concept achieved in new indication (moxidectin for head lice)
Phase 2 data from Investigator-led study leads to prioritisation of moxidectin for lymphatic filariasis program
2023
MDGH Receives FDA Orphan Drug Designation for Dovramilast to Treat Leprosy Type 2 Reaction
A Phase 2b moxidectin dose-finding study in people with scabies starts in the United States and Latin America
2024
January: MDGH receives US$1M grant for a moxidectin pilot community treatment program from the Helmsley Trust
June: MDGH receives A$16M grant for moxidectin and dovramilast programs from the Australian Government
September: A philanthropic grant from GiveWell and the Kladné nuly Foundation of AU $950,000 to support the moxidectin for river blindness program.
October: Recruitment into Phase 2b clinical trial for scabies completes
November: Ghana FDA approves moxidectin for the treatment of river blindness in adults and children aged 4 years and older.
2025
January: Ghana rolls out moxidectin, a new treatment for river blindness
February: U.S. FDA expands indication for moxidectin to treat river blindness in children as young as four.
April: MDGH receives U.S. FDA clearance of Investigational New Drug Application for dovramilast in leprosy type 2 reaction
June: Mark Sullivan AO publishes an article “Rethinking Pharmaceutical Development: A Not-for-Profit Model to Address Global Health Inequities” in the Royal College of Physicians’ Future Healthcare Journal (FHJ).
July: Publication of data from the first paediatric clinical study of moxidectin in the journal Parasites & Vectors by MDGH scientists and collaborators.
July: An article in The Lancet Infectious Diseases is published by Washington University in St Louis and partners and described, for the first time, the potential of moxidectin to accelerate lymphatic filariasis elimination efforts in Africa.
September: MDGH announces inclusion of moxidectin on World Health Organization Essential Medicines Lists.
October: Data published in The Lancet Infectious Diseases by Swiss TPH and suggest that moxidectin, in combination with albendazole, could serve as a promising alternative to the current treatment option for whipworm infections.
