globenewswire news
Expanded Access Case Report of SNIPR001, an Engineered CRISPR Medicine, in Rare Intracellular E. coli Disease Published in Clinical Infectious Diseases
COPENHAGEN, Denmark, Aug. 12, 2026 (GLOBE NEWSWIRE) -- SNIPR today announced the publication of a peer-reviewed expanded access case report in Clinical Infectious Diseases https://doi.org/10.1093/cid/ciag446 describing the use of SNIPR001 in a kidney transplant recipient with progressive, multidrug-resistant Escherichia coli malakoplakia, a rare disease characterized by intracellular bacterial persistence.
The case report was conducted by leading infectious disease investigators at the University of California San Diego under a single-patient emergency investigational new drug (eIND) application, supporting the translational potential of SNIPR001 in a real-world compassionate-use setting.
SNIPR001 is SNIPR’s lead engineered CRISPR-enhanced medicine designed to selectively target E. coli. In the published case report, the patient received intravenous, topical, and intralesional administration of SNIPR001 in addition to standard-of-care therapy, including antibiotics and adjunctive treatments.
According to the published report, treatment was associated with rapid healing of abdominal lesions and sustained radiographic regression of disease burden. The intra-abdominal malakoplakia mass decreased from 745 cm³ at baseline to 82 cm³ at one year, representing an 89% reduction. Follow-up urine and tissue cultures were negative following treatment, and no phage-related adverse events were reported during SNIPR001 administration.
“This case highlights the potential of phage therapy as a precision treatment for antibiotic resistant intra-cellular infections and MDR infections in general. For a patient facing a rare infection with very limited therapeutic options, phage therapy offered a novel approach that was both well tolerated and associated with a remarkable clinical response,” said Saima Aslam, MD, MS, FAST, Professor of Medicine in the Division of Infectious Diseases and Global Public Health, University of California San Diego and corresponding author on the published report.
“This case report marks an important clinical milestone for SNIPR001 and highlights the potential of our engineered CRISPR medicine platform to address difficult-to-treat, drug-resistant E. coli infections,” said Dr. Christian Grøndahl, CEO and co-founder of SNIPR. “We are grateful to the investigators at UC San Diego and to the patient and care team involved in this compassionate-use case, which provides valuable clinical insight into the potential role of SNIPR001 beyond prevention of bloodstream infections.”
SNIPR001 is currently being developed for the prevention of E. coli bloodstream infections in patients with hematological malignancies and is also being explored for the treatment of active E. coli infections. The publication adds to the growing clinical evidence base supporting the further development of engineered CRISPR medicines targeting drug-resistant E. coli infections.
About SNIPR001
SNIPR001 is a CRISPR-armed phage therapeutic designed to selectively target E. coli in the gut, with the aim of preventing infections from spreading into the bloodstream. Preclinical studies of SNIPR001 published in Nature Biotechnology reported activity against multidrug-resistant strains of E. coli and specificity towards E. coli, with no off-target effects observed in the non-E. coli strains tested. SNIPR has completed a Phase 1a trial in the US (NCT05277350), published in The Lancet Microbe. In that trial, no safety signals were identified, target engagement with E. coli was observed in the gut of healthy subjects, and no significant differences in overall gut microbiome composition were detected between SNIPR001 and placebo. SNIPR001 is under investigation as a preventative therapy for bloodstream infections in patients with hematological cancer. A Phase 1b/2a trial (NCT06938867), for which recruitment is complete, is being conducted at eight centers in the US. The trial is a randomized, double-blind, placebo-controlled study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered SNIPR001 in 24 patients with hematological cancer. SNIPR001 has been granted Fast Track designation for the indication "Prophylaxis of bloodstream E. coli infections in patients with hematological malignancy at risk of neutropenia" from the US Food and Drug Administration ("FDA"). SNIPR001 is also being developed to directly treat active E. coli infections. SNIPR001 is an investigational medicinal product. It has not been approved by the FDA, the EMA or any other regulatory authority, and its safety and efficacy have not been established.
About SNIPR
SNIPR is a Danish clinical-stage biotech company pioneering the development of CRISPR-medicine. We are pioneering a novel use of CRISPR-Cas technology to better treat and prevent human diseases through precision killing of bacteria or gene modification. SNIPR was the first company to orally dose humans with a CRISPR therapeutic and the first company to have been granted US and European patents for the use of CRISPR for targeting microbiomes. SNIPR technology is used in collaborations with CARB-X, Gates Foundation, Cystic Fibrosis Foundation, IPATH, SPRIN-D, and MD Anderson Cancer Center. For more information, visit www.sniprbiome.com and follow us on LinkedIn and X
Funding
Research reported in this press release is supported by CARB-X. CARB-X has been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Gates Foundation, Germany’s Federal Ministry of Research, Technology and Space (BMFTR), the Novo Nordisk Foundation, Italy’s Ministry of Economy and Finance (MEF), Japan’s Ministry of Health, the European Commission’s DG Health Emergency Preparedness and Response Authority (DG HERA), and KfW Development Bank. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. The content of this press release is solely the responsibility of SNIPR and does not necessarily represent the official views of any CARB-X funders.
Media Contact
Eric van der Helm | +45 31 88 02 56 | evdh@sniprbiome.com