Table 2.
Non‐traditional antibacterial agents in clinical development; adapted from WHO analysis (current to November 2021; World Health Organization, 2022).
| Name (synonym) | Phase | Antibacterial class | Route of administration | Developer | Expected activity against priority pathogens |
|---|---|---|---|---|---|
| Reltecimod (AB103) | NDA a | Synthetic peptide antagonist of both superantigen exotoxins and the CD28 T‐cell receptor | i.v. | Atox Bio | S. aureus |
| Tosatoxumab (AR‐301) | 3 | Anti‐S. aureus IgG1 antibody | i.v. | Aridis Pharmaceuticals | S. aureus |
| Exebacase (CF‐301) | 3 | Phage endolysin | i.v. | ContraFect | S. aureus |
| AR‐320 (MEDI‐ 4893, suvratoxumab) | 2 | Anti‐S. aureus IgG mAb | i.v. | Aridis Pharmaceuticals, licenced from AstraZeneca | S. aureus |
| LSVT‐1701 (N‐Rephasin SAL200, tonabacase) | 2a/1 | Phage endolysin | i.v. | Roivant Sciences, licenced from iNtRON | S. aureus |
| Phage | 1/2 | Phage | i.v. | Adaptive Phage Therapeutics | E. coli |
| Rhu‐pGSN (rhu‐plasma gelsolin) | 1b/2a | Recombinant human plasma gelsolin protein | i.v. | BioAegis Therapeutics | Non‐specific Gram‐positive and Gram‐negative |
| Ftortiazinon (fluorothyazinone) + cefepime | 2 | Thyazinone (type III secretion system inhibitor) + cephalosporin | Oral | Gamaleya Research Institute of Epidemiology and Microbiology | P. aeruginosa |
| TRL1068 | 1 | mAb | i.v. | Trellis Bioscience | Gram‐positive and Gram‐negative biofilms |
| 9 MW1411 | 1 | mAb (α‐toxin) | i.v. | Mabwell Bioscience | S. aureus |
| LBP‐EC01 | 1b | CRISPR‐Cas3 enhanced phage | i.v. | Locus Biosciences | E. coli |
| SVT‐1C469 | 1 | Live biotherapeutic product | Oral | Servatus | H. pylori |
| CAL02 | 1 | Broad‐spectrum anti‐toxin liposomal agent and nanoparticle | i.v. | Eagle Pharmaceuticals, licenced from Combioxin | S. pneumoniae b |
| GSK3882347 | 1 | Undisclosed (FimH antagonist) | Oral | GSK | E. coli |
| ALS‐4 | 1 | Anti‐virulence (staphyloxanthin biosynthesis inhibition) | Oral | Aptorum Group | S. aureus |
FimH, type‐1 fimbrin D‐mannose‐specific adhesin; IgG1, immunoglobulin G1; mAb, monoclonal antibody; NDA, New Drug Application; WHO, world health organisation.
a
Submitted to the US FDA as a potential treatment for necrotizing soft tissue infections in December 2020.
b
While the Phase 1 trial evaluated CAL02 on patients with severe pneumonia caused by S. pneumoniae, CAL02 has broad‐spectrum effects against other bacteria, such as P. aeruginosa, A. baumannii, Enterobacterales and S. aureus.