Clinical Update: SNIPR Biome Reports Positive Phase 1 Results For CRISPR-Armed Phage Therapy

SNIPR001 is SNIPR Biome's most advanced development candidate in its pipeline of CRISPR-based microbiome therapies, and the data released today revealed that oral dosing over seven days across three dose levels was well tolerated with only mild to moderate side effects and no withdrawals.

Of 36 Phase 1 SNIPR001 trial participants, 24 received SNIPR001 and 12 received a placebo. SNIPR001 could be recovered in faeces from treated individuals in a dose-dependent manner, and treatment reduced E. coli burden in the gut.

A novel treatment for bloodstream infections in at-risk cancer patients

SNIPR001 is being developed to initially treat potentially life-threatening E. coli infections in haematological cancer patients, i.e, individuals with cancer in the blood, bone marrow, or lymph nodes. These patients exhibit increased susceptibility to bloodstream infections as a result of disease and immune-compromising chemotherapy treatment, and are often treated pre-emptively with broad-spectrum antibiotics, such as fluoroquinolone which is ineffective against antibiotic-resistant bacteria and damages the gut microbiome. Such treatments inherently target bacteria indiscriminately and thus exacerbate the problem of antibiotic resistance.

According to a press release published by SNIPR Biome this morning, the new data demonstrate clinical proof of principle for CRISPR-armed phage therapy and also support the development of an intravenously (IV) administered formulation of SNIPR001. The company shared that it is currently planning studies to evaluate the ability of SNIPR001 to reduce the rate of infections in cancer patients at high risk of E. coli gut translocation into the bloodstream, as well clinical investigations for an IV version of SNIPR001.

The overall objective of the ongoing Phase 1 trial is to investigate the safety, tolerability, recovery and pharmacodynamics of SNIPR001 in healthy volunteers who will receive ascending doses of the candidate treatment, and to investigate its impact on E. coli colonisation in the gut.

The research work on SNIPR001 was supported by CARB-X, a global non-profit partnership accelerating antibacterial products to address drug-resistant bacteria, and the research findings upon which SNIPR001 was developed were published in Nature Biotechnology earlier this month.

SNIPR Biome received IND clearance from the U.S. FDA to initiate the SNIPR001 Phase 1 trial in January 2022. SNIPR001 was granted Fast-Track designation by the FDA in January 2022. The first individuals were dosed with the candidate therapy in April the same year.

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.