SNIPR BIOME ApS, a leading CRISPR and microbiome biotechnology company, is pleased to announce that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) Application, for our first development candidate, enabling the company to initiate the first clinical trial in humans with SNIPR001. The trial, which is scheduled to begin in first half of 2022, will investigate safety and tolerability in healthy volunteers, and investigate the effect of SNIPR001 on E. coli colonisation in the gut.
“The SNIPR BIOME team is excited about this important milestone, and we are looking forward to initiating the clinical trial in the US later this year, testing our unique CRISPR technology. SNIPR001 is our most progressed asset, and we are very proud of the team effort that brought us here” says Dr. Christian Grøndahl, Co-founder & CEO.
The clinical trial could pave the way for a new type of precision therapy to selectively target E. coli in cancer patients with hematological malignancies – which are cancers that affect the blood, bone marrow, and lymph nodes. These patients are at increased risk of life-threatening bloodstream infections due to the disease, to chemotherapy treatment and, importantly, to pathogen translocation from the gut, in which E. coli is one of the most important players in causing infection.
SNIPR001 aims to target E. coli bacteria in the gut, and thereby prevent the translocation of these bacteria to the bloodstream, while leaving the commensal bacteria in the patient’s microbiome unaffected. The approach with SNIPR001 is harnessing a novel application of our proprietary CRISPR/Cas technology to selectively eradicate E. coli bacteria from the gut. This precision approach could transform the way E. coli infections are prevented and treated, especially in the cancer ward.
“Based on our pre-clinical data with SNIPR001 we believe that our technology holds a huge potential in designing tomorrow’s CRISPR-based medicines against life-threatening infections and to modulate microbiome-associated diseases” says Dr. Milan Zdravkovic, Chief Medical Officer and Head of R&D at SNIPR Biome. “With the rise in anti-microbial resistance there is an urgent need for novel drug candidates to treat infectious bacteria, such as E. coli, and we are grateful for the collaboration with the non-profit organisation, CARB-X on SNIPR001”.