E!132, SECURE, CTC Clinical Trial Consultants AB

Purpose and goal:

Antimicrobial multi-resistance (AMR) is a global health problem, jeopardizing our ability to treat life-threatening infections and perform life-saving interventions such as surgery and cancer treatment.

SECURE project will develop an adjuvant drug to be administered with antibiotics. The adjuvant technology inhibits a wide range of resistance enzymes. This project will develop and validate a lead candidate (APC247), complete the preclinical research (in vitro and in vivo efficacy/safety) and complete the First-in-Human clinical study.

Expected results and effects:

We will demonstrate the preclinical safety, pharmacokinetics and efficacy of APC247, and advance this candidate into the first FIH clinical trial to provide human dose and safety data. The main outcome of the project is to document the preclinical Proof-of-Concept and complete the First-in-Human clinical study of APC247, a new first-in-class antibiotic adjuvant.

Approach and implementation:

The project will start with synthesis of the substance and further investigation of the mechanism of action of the substance. När GMP produced material is produced, it will be possible to start preclinical toxicological studies with the aim of studying the substance´s pharmacokinetic properties and safety profile. This data is then used to plan the first clinical study on humans, a so-called First in Human study, in which several different single doses of the substance will be evaluated.