Nontraditional Products for Bacterial Infections in Clinical Development

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Nontraditional Products for Bacterial Infections
Last Updated April 5, 2021

This piece was updated to change the drug type of KB109 from “live biotherapeutic product” to “synthetic polymer.”

As of December 2020, an estimated 36 new nontraditional products with the potential to treat or prevent serious bacterial infections were in clinical development.

The below interactive resource—based on publicly available information and informed by external experts and company communication—focuses on the nontraditional products currently in the clinical development pipeline. To view subsets of products, use filter options below or click on corresponding sections of the pie charts.

Please contact [email protected] with additions or updates.

March 2021 (XLSX) | March 2020 (XLSX) | September 2019 (PDF) | March 2019 (PDF) | September 2018 (PDF)  | September 2017 (PDF)  |  March 2017 (PDF)



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Issue Brief March 9, 2021

Assessment of Products to Combat Bacterial Infections

Because the conventional antibiotics pipeline remains so thin, finding new approaches is critical
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Issue Brief March 9, 2021

While antibiotic innovation—finding and designing new types of antibiotics and improving existing drugs—remains essential to combating antibiotic resistance, “outside-the-box” approaches to preventing and treating bacterial infections are also needed. Such nontraditional approaches encompass a variety of products.

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filtered results

Drug name Development phase Company Type Potential indication(s)
20vPnC Vaccines for S. pneumoniae have been approved and widely used. 20vPnC has the potential for expanded serotype coverage. Biologics license application submitted (U.S. FDA) Pfizer Inc. Vaccine
14
Development phase Company Type Target / mechanism of action
Biologics license application submitted (U.S. FDA) Pfizer Inc. Vaccine S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F
Reltecimod New drug application submitted (U.S. FDA) Atox Bio Ltd. Peptide immunomodulator
6
Development phase Company Type Target / mechanism of action
New drug application submitted (U.S. FDA) Atox Bio Ltd. Peptide immunomodulator Inhibits S. pyogenes and S. aureus superantigen activation of CD28
V114 Vaccines for S. pneumoniae have been approved and widely used. V114 has the potential for expanded serotype coverage. Biologics license application (U.S. FDA) and marketing authorization application (EMA) submitted Merck & Co. Inc. Vaccine
14
Development phase Company Type Target / mechanism of action
Biologics license application (U.S. FDA) and marketing authorization application (EMA) submitted Merck & Co. Inc. Vaccine S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F
DAV132 Phase 3 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. Da Volterra Antibiotic inactivator
8
11
Development phase Company Type Target / mechanism of action
Phase 3 Da Volterra Antibiotic inactivator Irreversibly adsorbs nonspecific antibiotic residues in the colon
Exebacase Phase 3 ContraFect Corp. Lysin
2
Development phase Company Type Target / mechanism of action
Phase 3 ContraFect Corp. Lysin S. aureus cell wall
PF-06425090 Phase 3 Pfizer Inc. Vaccine
8
Development phase Company Type Target / mechanism of action
Phase 3 Pfizer Inc. Vaccine TcdA and TcdB toxins
RBX2660/ RBX7455 RBX7455 is a lyophilized, oral formulation of the microbiota-based therapy, and RBX2660 is an enema formulation. Phase 3 Rebiotix Inc. (wholly owned subsidiary of Ferring Pharmaceuticals Inc.) Live biotherapeutic product
17
18
20
Development phase Company Type Target / mechanism of action
Phase 3 Rebiotix Inc. (wholly owned subsidiary of Ferring Pharmaceuticals Inc.) Live biotherapeutic product Microbiome modulation
SER-109 Phase 3 Seres Therapeutics Inc. (Nestlé Health Science licensee) Live biotherapeutic product
17
Development phase Company Type Target / mechanism of action
Phase 3 Seres Therapeutics Inc. (Nestlé Health Science licensee) Live biotherapeutic product Microbiome modulation
Salvecin (AR-301) Phase 3 Aridis Pharmaceuticals Inc. Monoclonal antibody
5
21
Development phase Company Type Target / mechanism of action
Phase 3 Aridis Pharmaceuticals Inc. Monoclonal antibody S. aureus α-toxin
514G3 Phase 2 XBiotech Inc. Monoclonal antibody
1
Development phase Company Type Target / mechanism of action
Phase 2 XBiotech Inc. Monoclonal antibody S. aureus protein A
Aerucin (AR-105) Phase 2 Aridis Pharmaceuticals Inc. (Serum Institute of India Ltd. licensee) Monoclonal antibody
5
21
Development phase Company Type Target / mechanism of action
Phase 2 Aridis Pharmaceuticals Inc. (Serum Institute of India Ltd. licensee) Monoclonal antibody P. aeruginosa alginate
Aerumab (AR-101) Phase 2 Aridis Pharmaceuticals Inc. (Serum Institute of India Ltd. licensee) Monoclonal antibody
5
21
Development phase Company Type Target / mechanism of action
Phase 2 Aridis Pharmaceuticals Inc. (Serum Institute of India Ltd. licensee) Monoclonal antibody P. aeruginosa lipopolysaccharide serotype O11
CAL02 Phase 2 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. Combioxin SA Virulence inhibitor
4
5
Development phase Company Type Target / mechanism of action
Phase 2 Combioxin SA Virulence inhibitor Sequesters and neutralizes Gram-positive and Gram-negative virulence effectors/ toxins
CP101 Phase 2 Finch Therapeutics Group Inc. Live biotherapeutic product
17
Development phase Company Type Target / mechanism of action
Phase 2 Finch Therapeutics Group Inc. Live biotherapeutic product Microbiome modulation
ExPEC10V (JNJ-69968054) Phase 2 Janssen Research & Development LLC Vaccine
26
Development phase Company Type Target / mechanism of action
Phase 2 Janssen Research & Development LLC Vaccine E. coli serotypes O1A, O2, O4, O6A, O8, O15, O16, O18A, O25B, and O75
ExPEC4V (JNJ-63871860) Phase 2 Janssen Research & Development LLC Vaccine
9
Development phase Company Type Target / mechanism of action
Phase 2 Janssen Research & Development LLC Vaccine E. coli serotypes O1A, O2, O6A, and O25B
GBS6 (PF-06760805) Phase 2 Pfizer Inc. Vaccine
10
Development phase Company Type Target / mechanism of action
Phase 2 Pfizer Inc. Vaccine Group B Streptococcus serotypes Ia, Ib, II, III, IV, and V
IMM-529 Phase 2 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. Immuron Ltd. Polyclonal antibody
17
Development phase Company Type Target / mechanism of action
Phase 2 Immuron Ltd. Polyclonal antibody TcdB toxin, spore antigens, and vegetative cell antigens
LBP-EC01 Phase 2 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. Locus Biosciences, Inc. Bacteriophage
30
Development phase Company Type Target / mechanism of action
Phase 2 Locus Biosciences, Inc. Bacteriophage Infects, degrades DNA using CRISPR-Cas3, and lyses E. coli, releasing more phage at site of infection
N-Rephasin (SAL200) (Tonabacase) Phase 2 Roivant Sciences/iNtRON Biotechnology Inc. Lysin
1
Development phase Company Type Target / mechanism of action
Phase 2 Roivant Sciences/iNtRON Biotechnology Inc. Lysin S. aureus cell wall
NTCD-M3 Phase 2 Destiny Pharma PLC Live biotherapeutic product
17
Development phase Company Type Target / mechanism of action
Phase 2 Destiny Pharma PLC Live biotherapeutic product Microbiome modulation
PhageBank Phase 2 Adaptive Phage Therapeutics Inc. Bacteriophage
22
23
24
28
Development phase Company Type Target / mechanism of action
Phase 2 Adaptive Phage Therapeutics Inc. Bacteriophage Infects and lyses ESKAPE+E and other bacterial pathogens specific to patient isolates, using phage(s) selected from a library, releasing more phage at site of infection
Ribaxamase (SYN-004) Phase 2 Synthetic Biologics Inc. Antibiotic inactivator
8
Development phase Company Type Target / mechanism of action
Phase 2 Synthetic Biologics Inc. Antibiotic inactivator Degrades intravenous β-lactam antibiotics in the gastrointestinal tract
Shigella4V (GSK4069327A) Phase 2 GlaxoSmithKline PLC/LimmaTech Biologics AG Vaccine
15
Development phase Company Type Target / mechanism of action
Phase 2 GlaxoSmithKline PLC/LimmaTech Biologics AG Vaccine O-antigen polysaccharides from S. sonnei, S. flexneri 2a, 3a, and 6
Suvratoxumab Phase 2 AstraZeneca PLC Monoclonal antibody
16
Development phase Company Type Target / mechanism of action
Phase 2 AstraZeneca PLC Monoclonal antibody S. aureus α-toxin
VE303 Phase 2 Vedanta Biosciences Inc. Live biotherapeutic product
17
Development phase Company Type Target / mechanism of action
Phase 2 Vedanta Biosciences Inc. Live biotherapeutic product Microbiome modulation
GSK2904545A Phase 1 GlaxoSmithKline PLC Vaccine
3
Development phase Company Type Target / mechanism of action
Phase 1 GlaxoSmithKline PLC Vaccine F2 antigen
GSK3878858A Phase 1 GlaxoSmithKline PLC Vaccine
27
Development phase Company Type Target / mechanism of action
Phase 1 GlaxoSmithKline PLC Vaccine Five S. aureus antigens
GSK3882347 Phase 1 GlaxoSmithKline PLC/Fimbrion Therapeutics Inc. Virulence inhibitor
25
Development phase Company Type Target / mechanism of action
Phase 1 GlaxoSmithKline PLC/Fimbrion Therapeutics Inc. Virulence inhibitor FimH adhesin
KB109 Phase 1 Kaleido Biosciences Live biotherapeutic product
30
Development phase Company Type Target / mechanism of action
Phase 1 Kaleido Biosciences Live biotherapeutic product Microbiome modulation
MET-2 Phase 1 NuBiyota LLC/Takeda Pharmaceutical Company Ltd. Live biotherapeutic product
17
Development phase Company Type Target / mechanism of action
Phase 1 NuBiyota LLC/Takeda Pharmaceutical Company Ltd. Live biotherapeutic product Microbiome modulation
PLG0206 Phase 1 Peptilogics Inc. Synthetic antimicrobial peptide
28
Development phase Company Type Target / mechanism of action
Phase 1 Peptilogics Inc. Synthetic antimicrobial peptide Membrane permeabilization
PolyCAb Phase 1 Clinical trial information for PolyCAb is currently registered in the WHO International Clinical Trials Registry Platform (http://apps.who.int/trialsearch). MicroPharm Ltd. Polyclonal antibody
3
Development phase Company Type Target / mechanism of action
Phase 1 MicroPharm Ltd. Polyclonal antibody TcdA and TcdB toxins
RECCE-327 Phase 1 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. Recce Pharmaceuticals Ltd. Synthetic polymer
29
Development phase Company Type Target / mechanism of action
Phase 1 Recce Pharmaceuticals Ltd. Synthetic polymer Binds to cell wall and induces bacterial cell lysis
SER-262 Phase 1 The company continues to evaluate microbiome pharmacokinetic and pharmacodynamic data from its SER-262 Phase 1b study and other completed clinical trials to inform the design of drug candidates in the pipeline and clinical trial design, and to determine next steps in the development of SER-262 to treat an initial recurrence of C. difficile infection. Seres Therapeutics Inc. (Nestlé Health Science licensee) Live biotherapeutic product
8
Development phase Company Type Target / mechanism of action
Phase 1 Seres Therapeutics Inc. (Nestlé Health Science licensee) Live biotherapeutic product Microbiome modulation
STEBVax Phase 1 Integrated BioTherapeutics Inc. Vaccine
13
Development phase Company Type Target / mechanism of action
Phase 1 Integrated BioTherapeutics Inc. Vaccine Recombinant mutated form of staphylococcal enterotoxin B (SEB)

Key

1
Bacteremia
2
Bacteremia including right-sided endocarditis
3
C. difficile infections
4
Community-acquired bacterial pneumonia
5
Hospital-acquired bacterial pneumonia
6
Necrotizing soft tissue infections
7
Prevention and treatment of C. difficile infections
8
Prevention of C. difficile infections
9
Prevention of extra-intestinal pathogenic E. coli infections
10
Prevention of group B Streptococcus infections
11
Prevention of gut colonization by multi-drug resistant organisms
12
Prevention of S. aureus skin and soft tissue infections
13
Prevention of S. aureus toxic shock syndrome
14
Prevention of S. pneumoniae infections
15
Prevention of shigellosis
16
Prevention of ventilator-associated bacterial pneumonia
17
Recurrent C. difficile infections
18
Recurrent urinary tract infections
19
Sepsis-associated acute kidney injury
20
Vancomycin-resistant enterococci elimination
21
Ventilator-associated bacterial pneumonia
22
Bacterial co-infections with COVID-19
23
Complicated urinary tract infections
24
Diabetic foot osteomyelitis
25
Prevention and treatment of uncomplicated urinary tract infections
26
Prevention of invasive extra-intestinal pathogenic E. coli disease
27
Prevention of recurrent S. aureus skin and soft tissue infections
28
Prosthetic joint infections
29
Sepsis
30
Urinary tract infections

For definitions of drug development terms and nontraditional product types, visit https://www.pewtrusts.org/en/research-and-analysis/articles/2014/03/12/glossary-for-the-antibiotic-pipeline .

See the methodology section for further details.

Note: The following drugs have been removed from the pipeline. Removed candidates will be included in future updates if development resumes:

  • June 2019: S. pneumoniae next generation vaccine (GSK-2189241A) was discontinued, according to a press release from the company.
  • December 2018: SA4Ag was removed because development was discontinued, according to a press release from the company.
  • June 2018: ASN100, GEN 004, Group B Streptococcus vaccine, and VLA84 (IC84) were removed because they were no longer included in the research and development pipeline on the company’s website.
  • September 2017: Shigamab and Cdiffense were removed because they were no longer included in the research and development pipeline on the company’s website.
Downloads Nontraditional Products for Bacterial Infections in Clinical Development (XLSX)
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This collection page was updated in December 2017 with new content. Drug-resistant bacteria, or superbugs, present a serious and worsening threat to human health. A majority of doctors have encountered patients with infections that do not respond to available treatments, and when new drugs come to market bacteria can quickly develop resistance. According to a report from the Centers for Disease Control and Prevention, 2 million Americans acquire serious infections caused by antibiotic-resistant bacteria each year, and at least 23,000 die as a result. A sustained and robust pipeline of new antibacterial drugs and novel therapies is critical to ensure that new interventions keep pace with these evolving pathogens.

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