Vancomycin with SER-287 more effective vs placebo for remission in UC
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Investigators found vancomycin preconditioning followed by SER-287 was significantly more effective compared with placebo for induction of remission in patients with active mild-to-moderate ulcerative colitis.
“SER-287 may represent a new therapeutic paradigm for UC with potential advantages with respect to safety and convenience of oral-dosing,” Matthew R. Henn, MD, from Seres Therapeutics in Cambridge, Massachusetts, and colleagues wrote. “Based on these results, daily SER-287 following vancomycin preconditioning is undergoing further evaluation in a phase 2b trial.”
In a phase 1b trial, Henn and colleagues performed a double-blind trial of 58 adult patients with active mild-to-moderate UC. Investigators randomly assigned patients into one of four groups in a 2:3:3:3 ratio; preconditioning with placebo followed by placebo or SER-287 once weekly or preconditioning with vancomycin followed by SER-287 once weekly or SER-287 once daily. Safety and clinical endpoints served as the clinical endpoints, and SER-287 engraftment served as the microbiome endpoints.
Investigators analyzed the stool specimens collected at baseline, after preconditioning, and during administration of SER-287 or placebo and 4 weeks after administration to measure the engraftment of SER-287, microbiome composition changes and correlated metabolites.
Results showed the groups did not significantly differ regarding proportions of patients with adverse events.
“A higher proportion of patients in the vancomycin/SER-287 daily group (40%) achieved clinical remission at week 8 than patients in the placebo/placebo group (0%), placebo/SER-287 weekly group (13.3%), or vancomycin/SER-287 weekly group (17.7%) (P = .024 for vancomycin/SER-287 daily vs. placebo/placebo),” Henn and colleagues wrote.
In all SER-287 groups, there were a higher number of SER-287 dose species detected in the stool samples by day 7 compared with the placebo group (P < .05). However, this was not maintained past day 7 in the SER-287 weekly group.
“In the vancomycin groups, a greater number of dose species were detected in stool collected on day 10 and all subsequent time points, through 4 weeks post-dosing, compared with the placebo group (P < .05),” the reserchers wrote.
On days 7 and 10, a higher number of SER-287 dose species were detected in stool samples in patients who received daily SER-287 doses compared with weekly doses (P < .05). Investigators noted fecal microbiome composition changes and metabolite changes correlated with vancomycin and SER-287.
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