SNIPR BIOME ApS, a leading CRISPR and microbiome gene therapy biotechnology company, announced dosing of the first human subjects in its phase 1 clinical trial with SNIPR001, an orally administered CRISPR-based therapeutic.

The purpose of the study is to investigate safety and tolerability of SNIPR001 in healthy volunteers and to evaluate the effect of SNIPR001 on reducing E. coli colonization in the gut. The study plans to enroll 36 healthy volunteers for multiple ascending dosing of SNIPR001 (NCT05277350). SNIPR001 has been granted Fast-Track designation by the FDA and is being developed in collaboration with the US non-profit organization CARB-X.

With the initiation of the First-in-Human study SNIPR BIOME becomes a clinical stage company. The experimental CRISPR therapeutic, SNIPR001, is designed to selectively target and eradicate E. coli in the gut, thus preventing translocation of these bacteria to the bloodstream, in a high-risk population of hematological cancer patients at risk for neutropenia. This precision approach could transform the way E. coli infections are prevented and treated, especially in the cancer ward. Today, there are no approved therapies for prophylactic therapy in this setting.

"Today, is a very special moment for SNIPR BIOME. For the first time ever, we are dosing a CRISPR-drug candidate in humans. Getting to this point is a major achievement and I am extremely proud of the whole SNIPR BIOME team, our collaborators, and advisors and especially our skilled CMC partner, Jafral, for their relentless effort in successfully bringing our first CRISPR-medicine into humans. However, this is only the beginning, and we truly believe that SNIPR001 could have the potential to help hematological cancer patients at increased risk of life-threatening bloodstream infections caused by multidrug resistant E. coli", says Dr. Christian Grøndahl, Co-founder & CEO.

Dr. Milan Zdravkovic, Chief Medical Officer and Head of R&D at SNIPR Biome, comments: "We are excited about having brought our first asset into humans and expect top line results around year-end. We are in parallel pursuing our pipeline of CRISPR-medicines of exciting targets within oncology, immunology and cardio-metabolism, and have an ambition of selecting the next molecule from our pipeline to move into IND enabling studies also by the end of this year"