Seres Therapeutics has published positive data analyses from its Phase Ib trial of SER-287 in patients with active mild-to-moderate ulcerative colitis (UC).
An oral biologically derived microbiome therapeutic candidate, SER-287 is designed to have pharmacological effects on various pathways significant to ulcerative colitis that can be modulated by gastrointestinal microbiome.
Earlier, the company had obtained ‘Fast Track’ designation from the US Food and Drug Administration for SER-287 in active mild-to-moderate UC.
The randomised, double-blind, placebo-controlled, multiple-dose, Phase Ib induction trial enrolled 58 participants.
They were randomised into four arms: daily SER-287 (preceded by short vancomycin conditioning regimen), weekly SER-287 (preceded by short vancomycin conditioning regimen), weekly SER-287 (preceded by placebo), and daily placebo (preceded by placebo).
Data from the study showed that SER-287 treatment was linked to positive impacts on clinical remission, endoscopic improvement and gastrointestinal microbiome modulation.
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A remission rate of 40% was noted in the daily SER-287 group versus 0% in placebo.
Furthermore, the safety and tolerability profile of the therapeutic candidate were observed to be favourable, with no drug-related serious adverse events (SAEs) noted.
Seres Therapeutics chief medical officer Lisa Moltke said: “Individuals with ulcerative colitis are in need of effective therapies with a favourable safety profile, and this Phase Ib study provided promising evidence suggesting that SER-287 has the potential to transform how this disease is managed.
“We look forward to furthering our understanding of SER-287 in our ongoing Phase IIb ECO-RESET study.”
The company noted that the Phase IIb study is currently enrolling participants, and topline data from the trial is anticipated in the second half of this year.
In August last year, Seres Therapeutics reported positive top-line data from the Phase III ECOSPOR III clinical trial of SER-109 to treat recurrent C difficile infection (CDI).