Novome announces positive results from GEMM cell therapy trial
Novome Biotechnologies announced positive results of its phase 1 trial evaluating NOV-001, a once-daily Genetically Engineered Microbial Medicine for the treatment of enteric hyperoxaluria.
“This study marks the first time that humans have been dosed with a therapeutically engineered microbe designed to engraft and grow in the human gastrointestinal tract,” Blake Wise, CEO of Novome, told Healio Gastroenterology. “The results of the study show that we can indeed controllably and safely engraft such a cell therapy into the gut.”
NOV-001, a Genetically Engineered Microbial Medicine (GEMM), is a combination product made up of a proprietary microbial strain engineered to degrade oxalate and a seaweed-derived prebiotic polysaccharide. Specific results from the phase 1 study found NOV-001 produced high levels of engraftment in the gastrointestinal tract while being minimally disruptive to the native gut microbiota. Further, researchers noted in the press release that NOV-001 was safe, well tolerated and carried no serious adverse events.
“These results, combined with our nonclinical models of enteric hyperoxaluria, have us excited about the potential for NOV-001 to effectively reduce urinary oxalate in these patients, high levels of which are associated with recurrent kidney stones,” Wise said. “We look forward to reporting clinical data next year from the phase 2a study in patients with enteric hyperoxaluria, as well as to build on this momentum and advance a pipeline of GEMM candidates to tackle a wide range of diseases.”