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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment, SNIPR001, in combination with the antibiotic levofloxacin for treating E. coli infections. The focus is on patients who have undergone a stem cell transplant and face E. coli resistant to typical antibiotics. Participants will receive either SNIPR001 or a placebo for up to 30 days. Suitable candidates include patients with blood cancers scheduled for a stem cell transplant and dealing with E. coli that resists standard antibiotics. As a Phase 1, Phase 2 trial, this research aims to understand how SNIPR001 works in people and measure its effectiveness in a smaller group, offering participants a chance to contribute to groundbreaking treatment development.

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.

Is there any evidence suggesting that SNIPR001 is likely to be safe for humans?

Research shows that SNIPR001, a new treatment being tested for E. coli infections, has demonstrated positive safety results in earlier studies. In past research with healthy volunteers, SNIPR001 was well-tolerated, with most participants experiencing no serious side effects. This treatment targets and kills E. coli bacteria in the gut, potentially preventing dangerous infections, especially in patients with certain types of cancer.

Although the current trial is in an early stage, focusing mainly on safety, earlier study results are encouraging. These findings suggest that SNIPR001 might be safe for humans, but ongoing trials will provide more information about its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional antibiotics that fight E. coli infections by killing or inhibiting bacterial growth, SNIPR001 is unique because it uses CRISPR technology to precisely target and eliminate harmful E. coli bacteria. This innovative mechanism reduces the risk of disrupting beneficial bacteria in the body, potentially decreasing side effects and resistance issues commonly associated with broad-spectrum antibiotics. Researchers are excited about SNIPR001 because its precision approach could lead to safer, more effective treatments for E. coli infections, offering a promising alternative to current antibiotic therapies.

What evidence suggests that SNIPR001 might be an effective treatment for E. coli infections?

Research has shown that SNIPR001 targets and kills E. coli, a harmful bacterium that can cause serious infections. Studies have found that this treatment reduces E. coli levels in the gut. SNIPR001 employs CRISPR technology, which acts like tiny scissors to specifically cut and destroy the bacteria. Early results from human trials have been positive, demonstrating that SNIPR001 effectively reduces E. coli without harming other beneficial bacteria. This trial will compare SNIPR001 to a placebo, and the promising results suggest that SNIPR001 could be an effective treatment for E. coli infections, especially in patients with weakened immune systems. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10869271/

Engineered phage with antibacterial CRISPR–Cas selectively ... SNIPR001 is in clinical development to selectively kill E. coli, which may cause fatal infections in hematological cancer patients. Subject terms: Drug ...

2. crisprmedicinenews.com crisprmedicinenews.com/news/clinical-update-snipr-biome-reports-positive-phase-1-results-for-crispr-armed-phage-therapy/

Clinical Update: SNIPR Biome Reports Positive Phase 1 ... SNIPR001 could be recovered in faeces from treated individuals in a dose-dependent manner, and treatment reduced E. coli burden in the gut. A ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06938867

Study Details | NCT06938867 | Phase 1b/2a Randomized ... Recovery of SNIPR001 from first dose of randomized treatment through 7 days after last dose randomized treatment in stool, blood and urine based on the number ...

4. cidrap.umn.edu cidrap.umn.edu/antimicrobial-stewardship/crispr-based-phage-therapy-shows-promise-first-human-trial

CRISPR-based phage therapy shows promise in first ... SNIPR Biome today announced positive results from a phase 1 study of their CRISPR-based phage therapy targeting Escherichia coli in the gastrointestinal tract.

5. insideprecisionmedicine.com insideprecisionmedicine.com/news-and-features/snipr-biome-reports-good-initial-in-human-results-for-crispr-gene-therapy/

SNIPR Biome Reports Good Initial "In-Human" Results for ... If proven effective, SNIPR001 has the potential to be a better treatment than fluoroquinolone as it only destroys the pathogenic E. coli ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05277350

NCT05277350 | A Study Investigating the Safety, Recovery ... A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects. ClinicalTrials.gov ID ...

7. cgtlive.com cgtlive.com/view/crispr-therapy-shows-proof-of-concept-in-preventing-antibiotic-resistant-e-coli-infection-in-patients-with-cancer

CRISPR Therapy Shows Proof-of-Concept in Preventing ... Investigators found that SNIPR001 was able to be recovered in feces from treated participants in a dose-dependent matter, and SNIPR001 treatment ...