COPENHAGEN, Denmark — September 17, 2026
SNIPR announced that the first patient has been enrolled in Part 2 of the Phase 1b/2a clinical trial of SNIPR001, expanding evaluation of its lead CRISPR-armed phage therapeutic candidate for prevention of Escherichia coli bloodstream infections in patients undergoing hematopoietic stem cell transplantation. The Phase 2 portion will enroll an additional 42 patients, bringing the total study population to 66 patients. The program builds on the successful Phase 1 evaluation in healthy subjects and the recruitment and dosing of 25 patients in Part 1 of the Phase 1b/2a study. Earlier clinical testing characterized safety, tolerability, pharmacokinetics and pharmacodynamics while demonstrating target engagement with E. coli in the gut. Topline Phase 2 results are expected in the second half of 2027.
SNIPR001 Targets E. coli Before Bloodstream Infection
SNIPR001 is designed to selectively target E. coli in the gut before bacteria can spread into the bloodstream, providing a targeted approach to infection prevention in highly vulnerable hematological cancer patients. The investigational therapy combines bacteriophage delivery with CRISPR technology intended to precisely eliminate targeted bacterial populations. Preclinical studies published in Nature Biotechnology reported activity against multidrug-resistant E. coli strains while maintaining specificity toward E. coli and showing no observed off-target effects in the non-E. coli strains tested. In a completed U.S. Phase 1a study, SNIPR001 produced no identified safety signals and demonstrated target engagement, while investigators observed no significant differences in overall gut microbiome composition between SNIPR001 and placebo. The company is now moving toward efficacy evaluation to determine whether this precision approach can translate into clinical prevention of bloodstream infections.
Phase 2 Expands U.S. Transplant Center Network
The Phase 2 expansion adds Memorial Sloan Kettering Cancer Center in New York and Dana-Farber Cancer Institute in Boston, strengthening SNIPR001’s clinical development network and bringing the study to 10 U.S. clinical sites. The randomized, double-blind, placebo-controlled study is evaluating orally administered SNIPR001 in patients with hematological cancer, with safety, tolerability, pharmacokinetics and pharmacodynamics forming part of the clinical assessment. The Phase 2 design was developed in alignment with the U.S. Food and Drug Administration (FDA) and implemented through a protocol amendment intended to provide a streamlined framework for evaluating efficacy in the target population. SNIPR001 has received FDA Fast Track designation for prophylaxis of bloodstream E. coli infections in patients with hematological malignancies at risk of neutropenia. The expanded investigator network provides additional expertise in hematological malignancies and stem cell transplantation as SNIPR moves the program into its next clinical stage.
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SNIPR Builds CRISPR-Phage Therapeutics Platform
The Phase 2 program represents a potential clinical proof-of-concept opportunity for SNIPR’s CRISPR-armed phage platform, while also extending the company’s broader precision-medicine strategy against bacterial disease. Development of SNIPR001 has received support from CARB-X, the Lundbeck Foundation and NEFO, with CARB-X providing funding and comprehensive program support since 2021 as the candidate progressed from preclinical development toward Phase 2. SNIPR is also developing SNIPR001 for the direct treatment of active E. coli infections and has established collaborations involving organizations including the Gates Foundation, Cystic Fibrosis Foundation, IPATH, SPRIN-D and MD Anderson Cancer Center. SNIPR001 remains investigational and has not been approved by the FDA, EMA or other regulatory authorities. With Phase 2 enrollment now underway and topline results expected in the second half of 2027, SNIPR is seeking to establish clinical evidence for targeted bacterial control using CRISPR-enabled phage therapy..
Source: SNIPR press release
