View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
July 23, 2021updated 11 Jul 2022 3:10pm

Seres’ drug fails in Phase IIb ulcerative colitis trial

The company will discontinue the open-label and maintenance portions of the ECO-RESET trial owing to no clinical efficacy signal.

Seres Therapeutics has reported that SER-287 failed to meet the primary goal of clinical remission in the Phase IIb ECO-RESET clinical trial in mild-to-moderate ulcerative colitis (UC) patients.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

SER-287 is a consortium of bacteria present in the gastrointestinal (GI) tract of healthy people. It is a donor-derived product candidate.

The placebo-controlled, double-blind, parallel-group, multi-centre Phase IIb trial enrolled a total of 203 UC patients at 104 centres across the US and Canada.

Trial subjects were randomised in a 1:1:1 ratio to receive either a full induction dose or step-down induction dose of SER-287 or a placebo.

The primary goal of the induction portion of the trial was the safety and efficacy of SER-287 in reaching clinical remission following ten weeks of dosing after vancomycin pre-conditioning.

As per the trial data, subjects receiving a full induction dose of SER-287 had 10.3% of clinical remission rates while the rates were 10.6% and 11.6% for step-down induction dose and placebo, respectively.

Seres noted that no meaningful clinical differences or statistical significance were reported in absolute clinical remission rates among the three study groups.

Furthermore, no meaningful changes in endoscopic improvement, endoscopic remission or symptomatic remission were demonstrated in the three groups.

Both the tested SER-287 dosing regimens were found to be generally well-tolerated.

Treatment-emergent adverse events (AEs) during the trial were reported in 67.6% and 46.2% of participants on induction dose and step-down dose, respectively, as against 50.7% on placebo.

The severity of most of the AEs was found to be mild or moderate.

As no clinical efficacy signal was detected in the trial, Seres decided to discontinue the open-label and maintenance portions of ECO-RESET.

Seres Therapeutics chief medical officer Lisa von Moltke said: “While the efficacy results in this trial did not meet the pre-defined threshold, we believe this data-rich study, including microbiome analyses expected in the second half of 2021, will provide valuable insights to inform the continued development of our pipeline, including SER-301, our next-generation investigational candidate for UC.”

The company is progressing its SER-301 programme, which is presently in a Phase Ib trial in Australia and New Zealand.

In January, Seres published positive data analyses from its Phase Ib trial of SER-287 in patients with active mild-to-moderate UC.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena