WASHINGTON — An investigational microbiome therapeutic showed efficacy in inducing remission in patients with mild-to-moderate ulcerative colitis, according to research presented at Digestive Disease Week 2018.
Bharat Misra, MD, of Borland-Groover Clinic in Jacksonville, Fla., presented data from a phase 1a trial that studied SER-287, an ecology of Firmicute bacterial spores administered through oral capsules.
“To date, there are no approved ulcerative colitis drugs targeting the triggers of inflammation rather than the inflammation itself,” Misra said during his presentation. “Hence, there was an unmet need for an oral, non-immunosuppressive therapeutic agent for the treatment of ulcerative colitis.”
Misra and colleagues conducted a double-blind, placebo-controlled trial of 58 patients with mild-to-severe UC. They randomly assigned the patients into four groups. Two groups receive 6 days of vancomycin pretreatment followed by 8 weeks of SER-287 either daily (n = 15) or weekly (n = 17). One group received a placebo pretreatment followed by weekly SER-287 (n = 15). The control group received a placebo for both stages of the study.
Misra and colleagues included efficacy outcomes of remission using a total modified Mayo score (TMMS), as well as endoscopic improvement and clinical response.
Of the 15 patients in the treatment arm that included vancomycin pretreatment and daily SER-287, 6 achieved remission (40%), compared with none of the patients in the control group (P = .024). Patients in the weekly dosing arm had remission and endoscopic improvement rates between the daily and placebo arms consistent with dose-dependent effect, according to the study.
Misra and colleagues said the findings warrant further research, considering the current unmet need for UC therapies.
“The daily dosing of SER-287 was associated with the highest rates of clinical and endoscopic remission,” Misra said. “Vancomycin may create an ecologic niche for SER-287 engraftment.”- by Alex Young
Misra B, et al. Abstract 85. Presented at: Digestive Disease Week; June 2-5, 2018; Washington, D.C.
Misra reports that he has financial ties to Seres Therapeutics. Please see the DDW faculty disclosure index for a list of all other authors’ relevant financial disclosures.
Editor's Note: The article was updated on June 25, to include more information from the presenter.