1. ABOUT GARDP FOUNDATION 

The Global Antibiotic Research & Development Partnership (GARDP Foundation) is a not-for-profit global health organization registered in Geneva, Switzerland. GARDP’s mission is to accelerate the development and access of treatments for drug-resistant bacterial infections. It does so by forging public-private partnerships all over the world to develop and expand access to treatments for serious bacterial infections and sepsis in adults, children and newborns, as well as sexually transmitted infections (STIs).

GARDP Foundation responds to the crisis in antimicrobial resistance. In 2015, the World Health Assembly, the decision-making body of the World Health Organization (WHO), adopted the Global Action Plan on Antimicrobial Resistance. The following year, to deliver on this plan, WHO and the Drugs for Neglected Diseases initiative created GARDP. In 2018, the GARDP Foundation was legally established as an independent entity.

Since then, GARDP Foundation has developed a portfolio of antibiotic treatments that targets WHO priority pathogens, priority diseases and key populations/regions that are especially affected by drug resistance. It is also pioneering new access initiatives with innovator, manufacturing and distribution partners.

As of 2024, the GARDP team consists of about 100 people who collectively share extensive cross-sector R&D and access experience. They work with the key public and private sector stakeholders and partners, such as the research and development community, donors, industry and implementing countries.

2. PROJECT BACKGROUND & PURPOSE OF THE RFP

Background to project 

Apramycin is an aminoglycoside approved only for animal use, currently. As opposed to all other aminoglycosides (AGs) currently used in the clinic which are di-substituted and monocyclic, apramycin is a mono-substituted, bicyclic deoxystreptamine.

In vitro and in vivo data indicate that apramycin has broad-spectrum activity with potential coverage for all GARDP’s critical priority pathogens. Interestingly, apramycin is resilient to almost all AGs resistance mechanisms typically found in multi-drug resistant (MDR) and extensively drug-resistant (XDR) Gram-negative bacteria, including bacteria that become resistant to AGs because of enzymes that methylate the target (16S RNA) and prevent binding of clinically used AGs. Moreover, this mechanism of AG resistance is commonly found in strains that are also resistant to carbapenems including due to the activity of metallo-β-lactamases .

So far, the only clinically relevant apramycin resistance mechanism is via AAC(3)-IV, an enzyme that confers resistance through N-acetylation of the apramycin molecule and that also confers resistance to gentamycin. Nevertheless, genomic analysis of clinical isolates shows very low prevalence despite 40 years of veterinary use.

Interestingly, preclinical in vitro and in vivo data suggest that apramycin has lower nephrotoxicity and ototoxicity than currently used AGs.

The initial development of apramycin for human use was being carried out by Juvabis, a swiss biotech, that generated the pre-IND data required to carry out a Phase 1 Single Ascending Dose (SAD) PK and safety study as well as an additional Phase 1 study to generate information on apramycin lung penetration (Phase 1 lung PK and safety study), the later carried out by NIAID.

Following Juvabis bankruptcy in 2024, GARDP acquired all Juvabis-generated data in June 2025 in order to pursue the development of this asset for human use.

Purpose of RFP 

The purpose of this Request for Proposal (RFP) is to solicit detailed proposals from qualified Contract Research Organizations (CROs) for the management and execution of that clinical study. The RFP aims to identify a CRO with the expertise, resources, and capability to deliver high-quality services that ensure the study’s success.

3. SCOPE OF WORK

The selected Contract Research Organization (CRO) will be responsible for the comprehensive management and execution of the clinical study (full services) as outlined in the attached Study Synopsis in accordance with their own SOPs. The scope of work includes the following key activities, further detailed in the Service Specifications:

• Feasibility, Site identification and Selection

• Medical writing

• Regulatory and Ethical submissions

• IMP management

• Project management

• Monitoring

• Study conduct

• Laboratory Analysis

• Data Management and Statistics

• Pharmacokinetic (PK) Analysis and Reporting (optional)

• PK kit supply (optional)

4. DELIVERABLES 

Cost of each deliverable based on contracted services should be confirmed at unit cost

level and total study costs in an excel budget grid considering following key

assumptions:

• 3 to 5 investigational sites in 1 country

• Patient population: hospitalized adult patients with confirmed or suspected cUTI or AP

• Estimated sample size: 24

A detailed study planning based on targeted key timelines:

• First participant First visit expected for June/July 2027

• Recruitment duration: expected 8 months

If you are interested to receive the complete documentation, please review, complete and sign that attached confidential framework and send it to: RFP_Procurement@gardp.org.

Due/closing date: July 24th, 2026