Clinical Update: SNIPR Biome Doses First Human Subjects With CRISPR-Based Antibiotic

Copenhagen-based SNIPR Biome announced this morning that it has dosed the first participants in a Phase 1 clinical trial for SNIPR001, an orally administered CRISPR-based therapeutic.

CRISPR-based oral antibiotic for hard-to-treat infections

SNIPR001 is designed to reduce E. coli colonisation in the gut, and is specifically developed to treat potentially life-threatening E. coli infections in haematological cancer patients, i.e., individuals with cancer in the blood, bone marrow, or lymph nodes.

Blood cancer patients exhibit increased susceptibility to bloodstream infections as a result of disease and immune-compromising chemotherapy, and are often treated pre-emptively with broad-spectrum antibiotics. Such treatments inherently target bacteria indiscriminately and thus contribute to the problem of antibiotic resistance. As of yet, there are no approved therapies for prophylactic treatment of bacterial infections in this setting.

Targeting the microbiome with CRISPR-Guided Vectors™

SNIPR Biome is using CRISPR-Cas technology to develop a pipeline of next-generation antibiotics for precise targeting of difficult-to-treat bacterial infections as well as complex diseases that implicate the microbiome. The company has developed new methods to deliver its CRISPR reagents as CRISPR-Guided Vectors™ (CGV™ Technology) into target bacterial cells.

CGVs are designed to selectively eradicate target bacteria in a sequence-specific manner, and are delivered to target bacterial cells via engineered bacteriophages or through bacterial conjugation. Once inside target cells, CGVs assemble into Cas-RNA complexes that create double-stranded breaks in bacterial genomes, leading to ultra-rapid killing in a matter of minutes, allowing rapid response in acute settings.

SNIPR001 is the most advanced development candidate in SNIPR's pipeline and it is designed to target certain E. coli bacteria in the gut and thus prevent their translocation to the bloodstream, without affecting beneficial bacteria in the microbiome.

During a CMN CRISPR delivery webinar last year, Eric van der Helm, VP of Synthetic Biology & Bioinformatics at SNIPR Biome, told us that SNIPR001 is developed as an oral medication that contains four E. coli-targeting phages, with demonstrated efficacy in animal disease models.

Phase 1 trial in healthy volunteers

The purpose of the ongoing Phase 1 trial is to investigate the safety and tolerability of SNIPR001 in 36 healthy volunteers who will receive ascending doses of the candidate treatment, and to investigate its impact on E. coli colonisation in the gut. SNIPR001 was granted Fast-Track designation by the FDA in January 2022 and is being developed in collaboration with the US non-profit organization CARB-X. You can read more about SNIPR's technology in an earlier interview with CEO Christian Grøndahl.

We will provide further details on the SNIPR001 trial as they emerge.

You can find all our previous news articles about IND approvals and clinical trials here. For a complete overview of CRISPR IND approvals and ongoing gene-editing trials, check out CRISPR Medicine News' Clinical Trials Database.