Nontraditional Products for Bacterial Infections in Clinical Development

Nontraditional Products for Bacterial Infections

As of September 2017, an estimated 32 new nontraditional products1 with the potential to treat or prevent serious bacterial infections are in clinical development. Below is a snapshot of the current nontraditional products pipeline, based on publicly available information and informed by external experts. It is updated periodically as products advance or are known to drop out of development. Because this list is updated periodically, endnote numbers may not be sequential.

Please contact abxpipeline@pewtrusts.org with additions or updates.

September 2017 (PDF)  |  March 2017 (PDF)

A data visualization from
A data visualization from The Pew Charitable Trusts
Sorted by:
Z-A
A-Z
Drug name

Development phase2

Drug name

Drug name

Development phase2

Development phase2

Company

Company

Type of product

Type of product

Potential indication(s)3

Potential indication(s)3
DSTA4637S

Phase 1

Drug name

DSTA4637S

Development phase2

Phase 1

Company

Genentech (member of the Roche Group)

Type of product

Antibody

Potential indication(s)3

Bacterial infections (S. aureus)
PolyCAb

Phase 1

Drug name

PolyCAb

Development phase2

Phase 1

Company

MicroPharm Ltd.

Type of product

Antibody

Potential indication(s)3

Recurrent C. difficile infection
RBX7455

Phase 1

Drug name

RBX7455

Development phase2

Phase 1

Company

Rebiotix Inc.

Type of product

Probiotic

Potential indication(s)3

Recurrent C. difficile infection
SER-262

Phase 1

Drug name

SER-262

Development phase2

Phase 1

Company

Seres Therapeutics Inc.

Type of product

Probiotic

Potential indication(s)3

Recurrent C. difficile infection
StebVax

Phase 1

Drug name

StebVax

Development phase2

Phase 1

Company

Integrated BioTherapeutics

Type of product

Vaccine

Potential indication(s)3

Prevention of toxic shock syndrome from staphylococcal enterotoxin B (SEB)
NDV-3A

Phase 1

Drug name

NDV-3A

Development phase2

Phase 1

Company

NovaDigm Therapeutics Inc.

Type of product

Vaccine

Potential indication(s)3

Prevention of bacterial infections (S. aureus)
514G3

Phase 2

Drug name

514G3

Development phase2

Phase 2

Company

Xbiotech Inc.

Type of product

Antibody

Potential indication(s)3

Bacteremia (S. aureus)
Aerucin (AR-105)

Phase 2

Drug name

Aerucin (AR-105)

Development phase2

Phase 2

Company

Aridis Pharmaceuticals Inc.

Type of product

Antibody

Potential indication(s)3

Pneumonia (P. aeruginosa)
VLA84 (IC84)

Phase 2

Drug name

VLA84 (IC84)

Development phase2

Phase 2

Company

Valneva SE

Type of product

Vaccine

Potential indication(s)3

Prevention of C. difficile infection
ASN100

Phase 2

Drug name

ASN100

Development phase2

Phase 2

Company

Arsanis Inc.

Type of product

Antibody

Potential indication(s)3

Prevention of ventilator-associated pneumonia (S. aureus)
V1148

Phase 2

Drug name

V1148

Development phase2

Phase 2

Company

Merck & Co. Inc.

Type of product

Vaccine

Potential indication(s)3

Prevention of pneumococcal disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F
CF-301

Phase 2

Drug name

CF-301

Development phase2

Phase 2

Company

ContraFect Corp.

Type of product

Lysin

Potential indication(s)3

Bacteremia (S. aureus)
CP101

Phase 2

Drug name

CP101

Development phase2

Phase 2

Company

Finch Therapeutics

Type of product

Probiotic

Potential indication(s)3

Recurrent C. difficile infection
ExPEC4V (JNJ-63871860)

Phase 2

Drug name

ExPEC4V (JNJ-63871860)

Development phase2

Phase 2

Company

Janssen Research & Development LLC

Type of product

Vaccine

Potential indication(s)3

Prevention of extraintestinal pathogenic E. coli serotypes O1, O2, O6, and O25 infection
Salvecin (AR-301)

Phase 2

Drug name

Salvecin (AR-301)

Development phase2

Phase 2

Company

Aridis Pharmaceuticals Inc.

Type of product

Antibody

Potential indication(s)3

Pneumonia (S. aureus)
Group B Streptococcus vaccine

Phase 2

Drug name

Group B Streptococcus vaccine

Development phase2

Phase 2

Company

GlaxoSmithKline

Type of product

Vaccine

Potential indication(s)3

Prevention of Group B streptococcal infection6
IMM-529

Phase 2

Drug name

IMM-529

Development phase2

Phase 2

Company

Immuron Ltd.

Type of product

Antibody

Potential indication(s)3

Recurrent C. difficile infection
SA4Ag

Phase 2

Drug name

SA4Ag

Development phase2

Phase 2

Company

Pfizer Inc.

Type of product

Vaccine

Potential indication(s)3

Prevention of S. aureus infection
Ribaxamase (SYN-004)

Phase 2

Drug name

Ribaxamase (SYN-004)

Development phase2

Phase 2

Company

Synthetic Biologics Inc.

Type of product

Antibiotic inactivator5

Potential indication(s)3

Prevention of C. difficile infection
PF-06482077

Phase 2

Drug name

PF-06482077

Development phase2

Phase 2

Company

Pfizer Inc.

Type of product

Vaccine

Potential indication(s)3

Prevention of Group B streptococcal infection
N-Rephasin (SAL200)

Phase 24

Drug name

N-Rephasin (SAL200)

Development phase2

Phase 24

Company

iNtRON Biotechnology Inc.

Type of product

Lysin

Potential indication(s)3

Bacterial infections (S. aureus)
MEDI3902

Phase 24

Drug name

MEDI3902

Development phase2

Phase 24

Company

MedImmune Inc.

Type of product

Antibody

Potential indication(s)3

Prevention of ventilator-associated bacterial pneumonia (P. aeruginosa)
GEN-004

Phase 24

Drug name

GEN-004

Development phase2

Phase 24

Company

Genocea Biosciences Inc.

Type of product

Vaccine

Potential indication(s)3

Prevention of pneumococcal infections (S. pneumoniae)
MEDI4893

Phase 24

Drug name

MEDI4893

Development phase2

Phase 24

Company

MedImmune Inc.

Type of product

Antibody

Potential indication(s)3

Hospital-acquired pneumonia (S. aureus)
Aerumab (AR-101)

Phase 24

Drug name

Aerumab (AR-101)

Development phase2

Phase 24

Company

Aridis Pharmaceuticals Inc.

Type of product

Antibody

Potential indication(s)3

Hospital-acquired/ventilator-associated pneumonia (P. aeruginosa serotype 011)
Shigella+

Phase 27

Drug name

Shigella+

Development phase2

Phase 27

Company

GlaxoSmithKline

Type of product

Vaccine

Potential indication(s)3

Prevention of Shigella infection
CAL02

Phase 27

Drug name

CAL02

Development phase2

Phase 27

Company

Combioxin SA

Type of product

Virulence inhibitor (liposome)

Potential indication(s)3

Severe pneumonia (S. pneumoniae)
S. pneumoniae next generation + vaccine (GSK-2189241A)8

Phase 27

Drug name

S. pneumoniae next generation + vaccine (GSK-2189241A)8

Development phase2

Phase 27

Company

GlaxoSmithKline

Type of product

Vaccine

Potential indication(s)3

Prevention of S. pneumoniae disease
PF-06425090

Phase 3

Drug name

PF-06425090

Development phase2

Phase 3

Company

Pfizer Inc.

Type of product

Vaccine

Potential indication(s)3

Prevention of C. difficile infection
RBX2660

Phase 3

Drug name

RBX2660

Development phase2

Phase 3

Company

Rebiotix Inc.

Type of product

Probiotic

Potential indication(s)3

Recurrent C. difficile infection
Reltecimod (AB103)

Phase 3

Drug name

Reltecimod (AB103)

Development phase2

Phase 3

Company

Atox Bio

Type of product

Peptide immunomodulator

Potential indication(s)3

Necrotizing soft tissue infections
SER-109

Phase 3

Drug name

SER-109

Development phase2

Phase 3

Company

Seres Therapeutics Inc.

Type of product

Probiotic

Potential indication(s)3

Recurrent C. difficile infection

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

    September 2017: Cdiffense and Shigamab were removed during the September 2017 review because they were no longer included in the research and development pipeline on the company's website or discontinuation of development was announced through a company press release.

Endnotes

  1. Products listed here contain at least one component not previously approved in the United States. This pipeline is limited to products with the potential to treat or prevent infections caused by bacterial pathogens considered by the Centers for Disease Control and Prevention to be urgent, serious, or concerning threats (CDC, “Antibiotic Resistance Threats in the United States, 2013,” Sept. 16, 2013, https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf). All analyses were limited to systemic products (drugs that work throughout the body) and therapies to treat Clostridium difficile-associated disease. We excluded drugs to treat mycobacterial infections, such as tuberculosis and Mycobacterium avium complex, Helicobacter pylori, and biothreat pathogens. Also excluded were locally acting therapies such as topical, ophthalmic, and inhaled products. Many of these products probably will not be used as a stand-alone treatment, but as an adjunctive to standard-of-care antibiotics.
  2. Based on the most advanced development phase for any indication according to trials registered in http://www.clinicaltrials.gov, unless direct communication from the company indicated differently. If no trials were included in clinicaltrials.gov, the phase listed on the company website or provided directly by the company is noted.
  3. Based on clinical trials currently registered in http://www.clinicaltrials.gov unless otherwise noted.
  4. Registered in http://www.clinicaltrials.gov but with no current study sites within the United States.
  5. Ribaxamase is a β-lactamase, which is given orally and prophylactically with an IV antibiotic. Ribaxamase degrades antibiotics in the GI tract to minimize collateral damage to the gut microbiome and prevent occurrence of C. difficile.
  6. In these clinical trials, the Group B Streptococcus vaccine is administered to pregnant women with the goal of preventing streptococcal infections in newborns.
  7. Not currently registered on http://www.clinicaltrials.gov. Information obtained from the company via a corporate website, news release, and/or direct company communication.
  8. Vaccines for S. pneumoniae have been approved and widely used. The products in development listed in this table have the potential for expanded serotype coverage.
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