Rebiotix and McMaster Children’s Hospital in Canada have announced that the first patient has been treated in the largest ever randomized, placebo controlled clinical trial of fecal microbiota transplantation in pediatric ulcerative colitis.
The division of pediatric gastroenterology and nutrition at McMaster Children’s Hospital is collaborating with Rebiotix to perform the PediFETCh trial, which will evaluate the efficacy of the clinical stage biotechnology company’s lead drug platform for microbial restoration therapy, RBX2660, which contains live microbes acquired from screened human donors, according to a press release. The FDA has previously granted orphan drug status, fast track status and breakthrough therapy designation to RBX2660.
“We are excited to launch this study using RBX2660 to help understand the role of intestinal bacteria in the treatment of pediatric ulcerative colitis,” Nikhil Pai, MD, FAAP, FRCPC, a pediatric gastroenterologist at McMaster Children’s Hospital and assistant professor of pediatrics at McMaster University’s Michael G. DeGroote School of Medicine, said in the press release. “By delivering a series of enemas containing live human bacteria into the intestines of children with UC, we may be able to alter the immune disruption that characterizes a disease that can be debilitating for children and their families.”
This study data will help guide the design of a multicenter pediatric study in the future, according to the press release. Participating researchers include Christine Lee, MD, medical director, infection prevention and control, St. Joseph’s Healthcare Hamilton and professor of pathology and molecular medicine at the Michael G. DeGroote School of Medicine at McMaster, Paul Moayyedi, MD, chair of gastroenterology, Hamilton Health Sciences and professor of medicine at the Michael G. DeGroote School of Medicine at McMaster, and Jelena Popov, BSc, from McMaster University. Robert Issenman, MD, division chief of pediatric gastroenterology, McMaster Children’s Hospital, and professor of pediatrics at the Michael G. DeGroote School of Medicine at McMaster, provided support and mentorship for the trial.
“Our collaboration with McMaster Children's Hospital exemplifies the passion and commitment of Rebiotix to apply our microbial restoration therapy platform to a range of challenging diseases such as ulcerative colitis,” Rebiotix CEO Lee Jones, said in the press release. “We remain focused on realizing the potential of the human microbiome to treat challenging gastrointestinal diseases.”
Disclosures: Healio Gastroenterology was unable to confirm relevant financial disclosures at the time of publication.