On January 25, 2022 SNIPR BIOME ApS, a leading CRISPR and microbiome biotechnology company, reported that it has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for SNIPR001 (Press release, SNIPR Biome, JAN 25, 2022, View Source [SID1234606793]). SNIPR001 is the company’s first development candidate targeting E. coli in patients with hematological malignancy at risk of neutropenia. This announcement comes only a few weeks after the FDA approved the Investigational New Drug (IND) Application paving the way initiating the first clinical trial in humans.
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"At SNIPR BIOME, we are extremely proud to have been granted Fast Track designation by the FDA. It underlines SNIPR001’s potential to be a game-changer for hematological cancer patients at increased risk of life-threatening bloodstream infections caused by E. coli" says Dr. Christian Grøndahl, Co-founder & CEO and continues, "E. coli was recently highlighted as one of the leading pathogens associated with anti-microbial-resistance (AMR) and death in a systematic review published by the scientific journal The Lancet, so there is an urgent need for new medicines targeting E. coli."
Fast Track is an FDA process designed to facilitate the development, and expedite the review, of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process and a rolling and/or priority review of its marketing application if relevant criteria are met.
Dr. Milan Zdravkovic, Chief Medical Officer and Head of R&D at SNIPR Biome, adds: "With the FDA’s Fast Track designation, we have reached yet another milestone and we are very pleased, that the FDA shares our view on the need to target AMR. Now, all our attention is directed towards initiating our first clinical trial, which is expected in H1 2022."
SNIPR001 is being developed in collaboration with the non-profit organisation CARB-X. The aim is to target E. coli bacteria in the gut, and thereby prevent translocation of these bacteria from the gut into the bloodstream, while leaving the commensal bacteria in the patient’s microbiome unaffected.
This precision medicine approach is harnessing a novel application of SNIPR BIOME’s proprietary CRISPR/Cas technology, hereby potentially transforming 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.