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SNIPR enrolls first patient in Phase 2 portion of SNIPR001 trial, expanding study to 66 patients

COPENHAGEN, Denmark, Sept. 17, 2026 (GLOBE NEWSWIRE) -- SNIPR today announced that the first patient has been enrolled in Part 2 of the Phase 1b/2a clinical trial of SNIPR001 (NCT06938867), the Company's lead CRISPR-armed phage therapeutic candidate for the prevention of Escherichia coli bloodstream infections in patients undergoing hematopoietic stem cell transplantation. The study will enroll an additional 42 patients, bringing the total study population to 66 patients.

The trial builds on the successful completion of the Phase 1 study in healthy subjects and the recruitment and dosing of 25 patients in Part 1 of the Phase 1b/2a study. In Phase 1, SNIPR001 characterized the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and showed target engagement.

The current study has also expanded to include two leading U.S. cancer centers - Memorial Sloan Kettering Cancer Center in New York and Dana-Farber Cancer Institute in Boston - further strengthening enrollment capabilities across ten clinical sites while adding world-class expertise in hematological malignancies and stem cell transplantation. Top-line results from the Phase 2 study are expected in the second half of 2027.

The Phase 2 study design was developed in alignment with the U.S. Food and Drug Administration (FDA) and implemented through a protocol amendment, providing a streamlined path toward evaluating the efficacy of SNIPR001 in the target patient population.

The Phase 2 study is supported through a combination of non-dilutive and investor funding, including CARB-X, the Lundbeck Foundation and NEFO. Along with non-dilutive funding, CARB-X has provided SNIPR001 with comprehensive support since 2021, helping advance the program from preclinical development to Phase 2.

"The addition of Memorial Sloan Kettering and Dana-Farber demonstrates the strong engagement from leading transplant centers and highlights the significant unmet need in this patient population," said Christian Grøndahl, Chief Executive Officer and Co-founder of SNIPR. "We are grateful for the commitment of our clinical investigators, patients, funding partners, and investors who have helped make this next stage of development possible."

The Phase 2 study is designed to generate efficacy data and has the potential to provide the first clinical proof-of-concept for SNIPR’s CRISPR-armed phage platform in patients. Success in the study would represent a significant step toward developing targeted approaches to prevent bloodstream infections in highly vulnerable cancer patients.

Funding

Research reported in this press release is supported by CARB-X. CARB-X is 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 the authors and does not necessarily represent the official views of CARB-X or its funders.

Media Contact

Christian Grøndahl | +45 2020 2747 | cg@sniprbiome.com


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