A novel combination treatment effective against all multidrug-resistant pathogens deemed as a critical priority by the WHO

Informazioni relative al progetto

sbli-ant3310

ID dell’accordo di sovvenzione: 190159682

DOI

10.3030/190159682

Progetto chiuso

Data della firma CE 20 Gennaio 2023

Data di avvio 1 Febbraio 2023

Data di completamento 31 Dicembre 2025

Finanziato da

• The European Innovation Council (EIC)

Costo totale

€ 5 618 870,00

Contributo UE

€ 2 500 000,00

Coordinato da

ANTABIO
France

Periodic Reporting for period 3 - sbli-ant3310 (A novel combination treatment effective against all multidrug-resistant pathogens deemed as a critical priority by the WHO)

Periodo di rendicontazione: 2025-04-01 al 2025-12-31

Sintesi del contesto e degli obiettivi generali del progetto

Antibiotic resistance is a growing global health crisis with major implications:
• Epidemiological: projected 10 million deaths per year by 2050.
• Medical: threatens treatments such as chemotherapy, surgery, and transplants.
• Economic: estimated global cost of 100,000 billion dollars per year.

ANTABIO’s mission is to develop innovative therapies against antibiotic‑resistant Gram‑negative bacteria, identified by WHO as the highest priority. MEM‑ANT3310 combines the well‑known antibiotic meropenem (MEM) with Antabio’s novel serine‑beta‑lactamase inhibitor ANT3310, which inhibits a broad range of beta‑lactamases, including KPC and OXA enzymes found in CRE and CRAB. This restores meropenem’s efficacy, particularly important for treating HAP/VAP and cUTI.

In February 2023, Antabio SAS entered a grant agreement with EISMEA for the project “A novel combination treatment effective against all multidrug-resistant pathogens deemed a critical priority by the WHO”. The objective is to bring MEM‑ANT3310 to market with a strong clinical package and secure a commercial partner.

A Phase 1 renal study was initiated to assess pharmacokinetics, safety, and tolerability in subjects with different renal functions and was successfully completed in early 2025. Based on these results, a Phase 1 lung PK study began in Q2 2025 to evaluate pulmonary penetration using BALF and ELF sampling. The study was completed in Q4 2025 and confirmed robust lung exposure supporting later‑phase dose selection.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

Antabio implemented key R&D activities to prepare the Phase 1 lung PK study of MEM‑ANT3310. A stable isotope‑labelled internal standard (C13/N15) was used to develop bioanalytical methods for clinical sample analysis (Task 1.4) completed in September 2024.

Process improvements (Task 1.2) included a safer and more efficient synthesis route for ANT3310 drug substance, a lyophilization process improving drug product stability, and simplification of co‑administration into a single infusion bag. A new GMP batch of ANT3310 drug product was manufactured and released with all specifications met (Task 1.3).

For the lung PK study, an IND application was submitted on 18 November 2024 and approved by the FDA on 16 December 2024 (Task 2.1). Ethics approval followed on 12 March 2025 (Task 2.2) enabling study initiation in Q2 2025. The trial was completed successfully in Q4 2025. A susceptibility study (Task 1.6) confirmed strong activity of MEM‑ANT3310 against Gram‑negative clinical isolates, including CRE and CRAB, consistent with CLSI and EUCAST guidelines.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

Within this project, significant advancements were made in the development of the MEM-ANT3310. The project has achieved key milestones in:
- Drug formulation and the Phase 1 lung PK clinical study preparation, including:
a) The successful synthesis of a stable isotopically labelled standard of ANT3310, enabling accurate bioanalytical method development and clinical samples analysis;
b) Optimization of the DS and DP production processes and
c) The successful manufacture of a clinical batch of ANT3310 under GMP conditions;
- Regulatory approvals, as both the IND application to the FDA and the ethics committee approval allowed the Phase 1 lung PK clinical study to begin;
- Antimicrobial efficacy assessment, as MEM-ANT3310 demonstrated strong activity against carbapenem-resistant clinical isolates, aligning with CLSI and EUCAST guidelines.
- Completion of the Phase 1 lung PK clinical study of MEM-ANT3310 and the evaluation of its pulmonary penetration and distribution.

This study has provided essential data on the drug’s absorption, distribution, and penetration within pulmonary tissue, confirming its suitability for treating respiratory infections caused by carbapenem-resistant pathogens.
For patients, the successful completion of the Phase 1 lung PK study means that MEM-ANT3310 is progressing towards becoming a new therapeutic option against multidrug-resistant Gram-negative infections, particularly those affecting the lungs. This brings renewed hope for improved clinical outcomes, especially in cases where existing treatments are ineffective, and underscores MEM-ANT3310’s potential to address a critical unmet medical need.

MEM-ANT3310 lab