The mission of ADVANCE-ID is to conduct high-quality clinical trials that have a global impact on management of infections. With the support of a multi-million dollar grant from the Wellcome Trust, ADVANCE-ID seeks expressions of interest from companies developing novel antimicrobial agents. The purpose of the grant is to conduct a Phase II clinical trial in the ADVANCE-ID network. In limited circumstances (for example, when a company is planning to skip from Phase I trials directly to a Phase III trial), a Phase III clinical trial may be considered. Data from the trial will be of sufficient quality to be included in the package for a New Drug Application to be submitted to the FDA, EMA and other similar organisations.
The Phase II trial will be conducted in close collaboration between ADVANCE-ID and the company developing the novel antimicrobial agent. It is anticipated that the award will cover the cost of a Phase II trial but depending on the complexity of the trial and other variables, the company developing the novel antimicrobial agent may need to co-contribute financially. If a Phase III trial is being considered, additional funding will definitely be required, and it may be appropriate to involve other geographic locations and/or clinical research networks and funders in the trial.
What is in scope?
Phase II or III trials of novel antimicrobial agents which are being developed for treatment (including treatment adjunctive to standard of care antibiotics) or prevention of infections due to multi-resistant Gram negative bacilli.
Both traditional small molecules and non-traditional antimicrobial agents are eligible for consideration.
There is no geographic restriction as to the location of the company developing the novel antimicrobial agent.
What is out of scope?
Antimicrobial agents being developed for tuberculosis, non-tuberculous mycobacteria, Neisseria gonorrhoea, Gram positive infections including Clostridium difficile, viral infections, fungal infections or parasitic infections.
March 15, 2024 Deadline for expression of interest submission
Q3 2024 Successful company will be informed
April 1, 2025 Contracting between successful company and NUS is complete
Q4 2025 First patient is enrolled