Novome Announces Phase 1 Trial of GEMM Cell Therapy

July 03, 2021

Novome Biotechnologies has announced the beginning of its phase 1 trial evaluating NOV-001, a once-daily Genetically Engineered Microbial Medicine for the treatment of enteric hyperoxaluria.

“With this significant milestone, we are advancing toward our goal of becoming a leader in the field of living therapeutics,” Blake Wise, CEO of Novome said in a press release. “We believe that our Genetically Engineered Microbial Medicine (GEMM) cell therapies hold tremendous potential for patients across a wide range of diseases, including ulcerative colitis and irritable bowel syndrome, in addition to enteric hyperoxaluria.”

In the phase 1 clinical trial, researchers will first evaluate the safety, tolerability and strain colonization pharmacodynamic of NOV-001 in healthy volunteers followed by a prospective, randomized, placebo-controlled phase 2 trial comprising patients with enteric hyperoxaluria. Trial results are anticipated later in 2021.

“This is the first time a human will be dosed with therapeutically engineered bacteria designed to colonize and grow in the gut,” Wise told Healio. “With this study we hope to prove Novome's platform GEMM technology is safe and can drive predictable results in colonizing a human microbiota.”