SNIPR enrolls first Phase 2 patient in CRISPR phage trial
SNIPR has enrolled its first patient in the Phase 2 portion of its Phase 1b/2a clinical trial of SNIPR001, the Copenhagen-based company's lead CRISPR-armed bacteriophage candidate. The study targets prevention of Escherichia coli bloodstream infections in patients undergoing haematopoietic stem cell transplantation (HSCT), a population at severe risk from opportunistic gram-negative infections. The expansion brings total planned enrolment to 66 patients across ten clinical sites, with top-line results anticipated in the second half of 2027.
SNIPR001 uses engineered phages carrying a CRISPR-Cas payload designed to selectively destroy E. coli strains in the gut before they can translocate into the bloodstream. The Phase 1 study in healthy volunteers previously characterised safety, tolerability, pharmacokinetics and pharmacodynamics, and demonstrated target engagement. Twenty-five patients completed dosing in Part 1 of the current study before the programme advanced to the Phase 2 expansion.
Site expansion and FDA alignment
Two high-profile US transplant centres have joined the study: Memorial Sloan Kettering Cancer Center in New York and Dana-Farber Cancer Institute in Boston. Their inclusion adds significant enrolment capacity and clinical credibility in haematological malignancies and stem cell transplantation, two areas where infection-related mortality remains a persistent challenge.
Chief executive and co-founder Christian Grøndahl said the participation of both centres "demonstrates the strong engagement from leading transplant centers and highlights the significant unmet need in this patient population."
The Phase 2 protocol was developed in alignment with the FDA and implemented via a protocol amendment, a process that typically signals a cleaner regulatory dialogue and may reduce friction ahead of any future registration-enabling study. SNIPR has not yet disclosed whether the FDA has granted the programme any expedited designation.
Antimicrobial resistance context and competitive landscape
Funding for SNIPR001 reflects the broader political and scientific urgency around antimicrobial resistance (AMR). CARB-X, which has supported the programme since 2021, draws from a multinational pool of public funders including BARDA, the Wellcome Trust, the Gates Foundation and several European and Asian health ministries. Additional non-dilutive support comes from the Lundbeck Foundation and NEFO, supplemented by conventional investor capital.
The AMR phage therapy field has attracted a small but growing cohort of companies pursuing precision antimicrobials that spare the broader microbiome. Unlike conventional antibiotics, phage-based approaches can in principle be engineered to hit a single bacterial species or even a specific strain. SNIPR's CRISPR-armed variant extends that specificity by delivering a gene-editing payload that disrupts bacterial DNA. Whether this translates into superior clinical outcomes remains to be demonstrated, and the Phase 2 data expected in late 2027 would represent the first proof-of-concept in patients for this platform class.
Gram-negative bacteraemia in HSCT recipients carries mortality rates that have proved resistant to incremental improvement with existing antibiotics. Regulatory agencies on both sides of the Atlantic have signalled willingness to accept novel endpoints and adaptive designs for AMR indications, which could support a more accelerated development path for SNIPR001 if the efficacy signal is compelling. Success in this study would also have read-across implications for other phage-based programmes targeting enteric pathogens in immunocompromised hosts.