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, 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
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
