GARDP aims to develop and deliver a new first-line treatment for clinically diagnosed cases of neonatal sepsis where drug-resistant Gram-negative pathogens are suspected, as well as a new treatment for confirmed multidrug-resistant pathogens. Progress to date includes developing two target product profiles (TPPs) and building solid partnerships and multi-stakeholder collaborations. These include St George’s, University of London to conduct an observational study and input into the pharmacokinetic (PK) and pharmacodynamic (PD) assessment of potential drug candidates and the PENTA Foundation.
Discussions are ongoing to identify a partner to coordinate and monitor microbiological activities including determining the phenotypic and genotypic resistance profiles of invasive and colonizing Gram-negative isolates.
A scoping study of existing drugs and the drug pipeline is ongoing to identify treatments that meet the predefined criteria of the TPPs. The initial feasibility survey, conducted in 2017, confirms the critical need and high levels of drug resistance with significant variation in treatment protocols in place in countries (i.e. significant use of carbapenems as a treatment for late onset sepsis). Protocols for an observational and clinical PK study are ready for implementation in early 2018. A stewardship and access plan is under development.
GARDP’s STI strategy addresses the threat of untreatable gonorrhoea by accelerating the development of new drugs, and is investigating combinations while emphasizing access and stewardship. Short and long-term target product profiles have been developed to guide the project.
The partnership agreement with Entasis Therapeutics, signed in 2017 to co-develop zoliflodacin, is a major milestone for GARDP. The announcement coincided with new data released by the World Health Organization showing that of 77 countries surveyed across the world, more than 60% report resistance to the last-resort treatment for gonorrhoea. Phase III clinical trials are now being planned in Europe, South Africa, Thailand, and the USA for zoliflodacin. The National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health, has committed to support pharmacological studies on the drug as part of the development programme in early 2018.
The chemistry, manufacturing, and controls plan has been finalized and a development partner selected to generate a package ready for marketing authorization application in 2021. In addition, a partnership agreement has been signed with the University Hospital Örebro (Sweden) to further characterize the in vitro activity of zoliflodacin.
To date, the memory recovery programme has identified over 400 experts, 120 of whom have agreed to participate in the ‘REVIVE’ hub, an online space for the antimicrobial community to connect. While already live, the hub is being user tested to improve its functionality and ensure that the appropriate resources are developed. Live webinars and workshops are planned for 2018. In addition, five pharmaceutical companies have shared assets with GARDP, with 20 ‘recovered’ molecules being actively explored. To pool efforts towards developing new antibiotics and to avoid duplication of efforts, collaborations are being built with similarly focused entities and funding bodies such as CARB-X.
To further the exploratory programme, two expert meetings have been held to help define clinical needs and possible activities. An outline programme strategy was approved by the Scientific Advisory Committee and the Board of Directors. This is now under active development. Discussions are ongoing with individual companies and academic groups about innovative discovery approaches. Collaboration agreements are in progress with academic and private sector groups to support specific exploratory and discovery initiatives.
More information on GARDP’s Programmes