SNIPR001 / SNIPR BIOME - LARVOL DELTA

First-in-Human Adjunctive Bacteriophage Therapy for Malakoplakia. (PubMed, Clin Infect Dis) - "We report the first use of adjunctive bacteriophage therapy for Escherichia coli related malakoplakia in a kidney transplant recipient with progressive disease. Adjunctive CRISPR-enhanced phage cocktail SNIPR001 combined with prolonged antibiotics, ascorbic acid, and bethanechol was associated with cutaneous lesion resolution and sustained radiographic regression without phage-related adverse events."

First-in-human • Journal • P1 data • Transplantation

CRISPR-based gene editing for antimicrobial resistance control in human medicine. (PubMed, Arch Microbiol) - P1, P2 | "The present state of clinical translations is discussed, including the two most advanced clinical-stage candidates SNIPR001 (Phase I/II, NCT05277350) and LBP-EC01 (Phase 2/3, NCT05488444). We also address the open issues that include off-target editing, host immune reactions, bacterial counter-resistance, regulatory ambiguity, and scalability of manufacturing. Lastly, we provide priority research directions, such as the combination antimicrobial strategies, AI-assisted CRISPR design, and next-generation delivery engineering, none of which will be resolved before routine clinical application of CRISPR-based antimicrobials is achieved."

Journal • Review • Gene Therapies

Engineered phage therapy using parenteral and intravesical delivery of CRISPR-Cas armed phages (SNIPR001) in mice increase survival and reduces infection? (ESCMID Global 2026) - No abstract available

Preclinical • Infectious Disease

Safety, recovery, and pharmacodynamics of CRISPR-Cas therapeutic SNIPR001: a phase 1, randomised, double-blind, first-in-human, dose-escalation study. (PubMed, Lancet Microbe) - P1 | "This first-in-human study of SNIPR001 supported its safety, tolerability, and restriction to the gastrointestinal tract, while not systemically disrupting the gut microbiome. These results justify further clinical development of SNIPR001 in an ongoing phase 1b/2a trial."

First-in-human • Journal • P1 data • PK/PD data • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Infectious Disease • Oncology • Pain • Transplantation

Armed Phages: A New Weapon in the Battle Against Antimicrobial Resistance. (PubMed, Viruses) - "SNIPR001 has completed a Phase I clinical trial evaluating safety in healthy volunteers, while LBP-EC01 is in Phase II trials assessing its performance in the treatment of Escherichia coli-induced urinary tract infections in patients with a history of drug-resistant infections. As "armed phages" progress toward clinical application, they hold great promise for precision-targeted antimicrobial therapies and represent a critical innovation in addressing the global antibiotic resistance crisis."

Journal • Review • Infectious Disease • Nephrology

Phase 1b/2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplant Receiving FQ Prophylaxis & Harboring FQR Ecoli PreTransplant (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: SNIPR Biome Aps. | N=240 ➔ 24

Enrollment change • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Oncology • Transplantation

Phase 1b/2a, Where Patients Are Chosen Randomly to Test the Safety of SNIPR001 and to Assess How Well the Study Drug is Tolerated, How it is Absorbed in the Body and Its Initial Effectiveness in Patients With Certain Types of Blood Cancer (clinicaltrials.gov) - P1/2 | N=240 | Recruiting | Sponsor: SNIPR Biome Aps.

New P1/2 trial • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Neutropenia • Oncology • Transplantation

A Phase 1, randomised, double-blind, first-in-human, dose-escalation study investigating the safety, recovery, and pharmacodynamics of a novel CRISPR-Cas therapeutic (SNIPR001) (ESCMID Global 2025) - No abstract available

Clinical • P1 data • PK/PD data

SNIPR Biome receives funding from CARB-X to support advancement of CRISPR-medicine SNIPR001 into clinical trials in haematological cancer patients (GlobeNewswire) - "SNIPR Biome ApS...announces today that it has received $5.48 million from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator ('CARB-X') to co-fund a Phase 1b/2a clinical trial in hematological cancer patients. The trial will evaluate SNIPR001, the first CRISPR-armed phage therapeutic that specifically targets E. coli in the gut, for the prevention of E. coli bloodstream infections in hematological cancer patients who are undergoing hematopoietic stem-cell transplantation (HSCT) and are colonized with Fluoroquinolone Resistant (FQR) E. coli. It will be conducted at up to 10 sites across Europe and the United States."

Financing • New P1/2 trial • Hematological Malignancies • Oncology

A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: SNIPR Biome Aps. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

Engineered phage with antibacterial CRISPR-Cas selectively reduce E. coli burden in mice. (PubMed, Nat Biotechnol) - "A combination of the four most complementary bacteriophages, called SNIPR001, is well tolerated in both mouse models and minipigs and reduces E. coli load in the mouse gut better than its constituent components separately. SNIPR001 is in clinical development to selectively kill E. coli, which may cause fatal infections in hematological cancer patients."

Journal • Preclinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Oncology

A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: SNIPR Biome Aps. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

SNIPR Biome Launches A Non-Profit Patent Licensing Program To Enable The Field of CRISPR Editing in Prokaryotes (GlobeNewswire) - "SNIPR Biome ApS...announces that its patent portfolio covering the use of CRISPR/Cas systems to edit prokaryotes is now available for academic and non-profit research use without a written license.... These technologies underpin SNIPR’s broad R&D pipeline which addresses the unmet needs of high-risk patient groups. SNIPR’s lead program (SNIPR001), a CRISPR-armed bacteriophage cocktail that targets antibiotic-resistant E. coli infections in hematological cancer patients, is currently in the clinic in the US undergoing Phase I trials."

Patent • Hematological Malignancies • Oncology

A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: SNIPR Biome Aps. | Trial primary completion date: Jan 2023 ➔ Oct 2022

Trial primary completion date • Infectious Disease

A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: SNIPR Biome Aps. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

A Phase 1, Randomized, Double-Blind, First-In-Human, Dose Escalation Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: SNIPR Biome Aps.

New P1 trial • Infectious Disease