Activity Update: May 2016 – January 2017

The Global Antibiotic Research and Development Partnership (GARDP) is a not-for-profit research and development organization that addresses global public health needs by developing and delivering new antibiotic treatments while endeavouring to ensure sustainable access. Initiated and incubated through close collaboration between WHO and the Drugs for Neglected Diseases initiative (DNDi), GARDP is part of the implementation of the Global Action Plan on Antimicrobial Resistance that calls for new public-private partnerships for encouraging research and development of new antimicrobial agents and diagnostics. GARDP has received seed funding and pledges from the governments of Germany, the Netherlands, South Africa, and Switzerland, the United Kingdom of Great Britain and Northern Ireland as well as from the medical humanitarian organization Médecins Sans Frontières which exceed €5 million for 2016-2018. GARDP is a joint WHO/DNDi initiative being hosted by DNDi in its start-up phase.

GARDP has, within its first 8 months, built up a team of 10 people with additional support staff from DNDi contributing directly to GARDP programmes.

 

Research & Development Programmes

A Scientific Advisory Group of 17 experts oversees the creation of the initial research and development (R&D) portfolio. The DNDi Board approved the draft business plan in December 2016.

 

The following R&D projects have been identified thus far:


Neonatal Sepsis

While significant achievements have been made in reducing mortality in children under age five, mortality remains a burden in children less than one month of age, with antimicrobial resistance posing a particular threat. This programme aims to develop and deliver a new first-line treatment for pathogens causing neonatal sepsis as well as a new treatment for confirmed multi-drug resistant pathogens. Two target product profiles (TPPs) have been generated to guide the development of the new treatments.

Status:
  • Programme approved by the Scientific Advisory Group and validated by DNDi
  • A Project Leader and a part-time Senior Clinical Manager has been hired.

Antimicrobial Memory Recovery Initiative (AMRI)

With the disengagement from antibiotic R&D of many of the large pharmaceutical actors, much of the knowledge and material resources that were part of the ‘golden era’ of antibiotic drug discovery and development have been forsaken. AMRI aims to recover the knowledge, contacts, data, and assets of forgotten, abandoned, or withdrawn antibiotics as a ‘bridging’ measure while the search for new classes of antibiotics is being pursued and while, hopefully, a new generation of researchers in antibiotic R&D is stimulated and rebuilt.

Status:
  • Programme approved by the Scientific Advisory Group and validated by the DNDi
  • A Head of Transversal Programmes is in place and a project assistant has been recruited.

Sexually transmitted diseases

Over the past few years, serious concerns have been raised globally over the spread of resistant gonorrhoea. Neisseria gonorrhoeae is threatening to soon become untreatable due to its resistance to all available classes of available antimicrobials. This programme will seek to develop and deliver two new treatments for gonorrhoea patients with drug-resistant infections by combining existing antibiotics and by exploring new antibiotics that are already in development. Two target product profiles have been developed to guide the project.

Status:
  • The disease strategy document is completed and ready for Scientific Advisory Group review.
  • The DNDi Board approved the programme strategy development. A part-time Senior Clinical Manager has been hired.

Paediatric Antibiotic Platform

This programme aims to establish a platform to optimize current and new antibiotics for children through improvements in dose, duration, formulation or through combinations based on the gap analysis that will be undertaken with WHO. Depending on the outputs of the initial scoping exercise to be undertaken throughout 2017, approximately two projects are anticipated.

Status:
  • Exploratory work is being undertaken and the draft programme is under review.

Drug Combination Platform

This programme aims to establish a screening and in vivo drug development platform to optimize combinations of existing and/or new antibiotics as well as non-antibiotic substances for GARDP priority pathogens, including Nesseria gonorrhoea, Klebsiella, and Acinetobacter. The platform will identify effective combinations, investigate their pharmacokinetic and pharmacodynamic properties and efficacy in vivo as well as the most suitable formulations.

Status
  • A Head of Transversal programmes has been employed and the platform is currently undergoing exploration.

 

Contact:

  • GARDP/DNDi: Gabrielle Landry, External Affairs, GARDP, glandry@dndi.org
  • WHO: Peter Beyer, Senior Advisor, beyerp@who.int