SNIPR001 for E. coli Infections

Recruiting at 7 trial locations

Overseen By Alice Troy

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: SNIPR Biome Aps.

Must be taking: Fluoroquinolones

Must not be taking: Beta-lactams

Disqualifiers: Pregnancy, Lactation, Hypersensitivity, others

Compensation: Varies

Number of Visits: 1

Duration: 1 week

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you cannot use any treatments that might interact with the study drug within 14 days before starting the trial. You also cannot use antibiotics that work against E. coli in the gut, except for TMP-SMX and levofloxacin.

How does the treatment SNIPR001 for E. coli infections differ from other treatments?

SNIPR001 is unique because it likely involves bacteriophages, which are viruses that specifically target and kill bacteria, offering a targeted approach to treating E. coli infections without disturbing the beneficial bacteria in the gut, unlike traditional antibiotics. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a Phase 1b/2a study in allogenic hematopoetic stem cell transplant patients to investigate the safety, PK, PD and preliminary efficacy of multiple oral administrations of SNIPR001 when given concomitantly with SoC levofloxacin.

Eligibility Criteria

This trial is for patients who have had an allogeneic hematopoietic stem cell transplant and are dealing with E. coli infections. Participants must meet certain health standards, which aren't specified here.

Inclusion Criteria

Patient is able and willing to provide written informed consent prior to any study-related procedure

I am scheduled for a stem cell transplant from a donor.

I will use effective birth control during and for 28 days after my last dose of SNIPR001.

Exclusion Criteria

Unwilling or unable to comply with the requirements of this Protocol, including providing stool samples

I am not planning to use certain antibiotics that target E. coli, except for TMP-SMX and levofloxacin.

Use of any treatment (approved or investigational product) considered to interact with the study drug, or which might impact the outcome of the study within 14 days (or 5 half-lives of the approved or investigational product, whichever is greater) prior to the first administration of study drug, as judged by the Investigator. Patients enrolled in any other clinical trials are excluded from participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive SNIPR001 or placebo BID for 7 days along with SoC levofloxacin prophylaxis

1 week

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment until 30 days post allo-HSCT transplant

4 weeks

Weekly visits (in-person)

Treatment Details

Interventions

• SNIPR001

Trial Overview The study is testing SNIPR001, a genetically engineered treatment targeting E. coli, against a placebo. It's to see how safe it is, how the body absorbs it, and if it shows any early signs of working when taken with standard antibiotics.

Participant Groups

Group I: SNIPR001 Active Active Control 1 Intervention

12 patients on SNIPR001 (BID for up to 30 days)

Group II: Placebo Placebo Group 1 Intervention

12 patients on Placebo (BID for up to 30 days)

Who Is Running the Clinical Trial?

SNIPR Biome Aps.

Lead Sponsor

Trials

1

Recruited

40+

German Federal Ministry of Education and Research

Collaborator

Trials

232

Recruited

142,000+

Bill and Melinda Gates Foundation

Collaborator

Trials

428

Recruited

23,060,000+

Department of Health and Social Care (DHSC), UK

Collaborator

Wellcome Trust

Collaborator

Trials

236

Recruited

15,770,000+

Biomedical Advanced Research and Development Authority

Collaborator

Trials

108

Recruited

574,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Characterization and comparative genomic analysis of a novel bacteriophage, SFP10, simultaneously inhibiting both Salmonella enterica and Escherichia coli O157:H7. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Host receptor identification of a polyvalent lytic phage GSP044, and preliminary assessment of its efficacy in the clearance of Salmonella. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Lineage and genogroup-defining single nucleotide polymorphisms of Escherichia coli O157:H7. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Bacteriophages Reduce Pathogenic Escherichia coli Counts in Mice Without Distorting Gut Microbiota. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

In Vitro Characterization and In Vivo Efficacy Assessment in Galleria mellonella Larvae of Newly Isolated Bacteriophages against Escherichia coli K1. [2023]