Lisa von Moltke
Analyst · Ted Tenthoff with Piper Sandler. Your lines open
Thanks, Eric, and good morning everyone. I'll begin with a recap of our SER-109 Phase 3 data that we announced in August. The top line results demonstrated that SER-109 met the study's primary eight- week end point with SER-109 showing a remarkable 30.2% absolute reduction of recurrences CDI compared to placebo at eight weeks post treatment. We were also extremely pleased to see that the results demonstrated a highly favorable safety profile, with SER-109 adverse events looking similar to placebo. In late October, we presented a top line Phase 3 results, as well as some additional clinical study data at the American College of Gastroenterology Annual Scientific Meeting. New data showed that at 12 weeks post-administration, the rate of recurrence in the SER-109 arm was consistent with the results seen at eight weeks, which was the study's primary endpoint. Additionally, we presented data demonstrating that SER-109 administration resulted in similar efficacy when stratified by age or by the prior antibiotic received. We have heard substantial physician interest regarding SER-109 and many have highlighted the enormous medical and financial burdens of this disease, and they have expressed enthusiasm that SER-109 could represent a major advance for this field. Now moving to our SER-287 program, which is an ongoing Phase 2b study in patients with mild to moderate, clinically active ulcerative colitis. SER-287 is an orally administered, biologically derived drug candidate comprised of commensal bacterial spores isolated from the healthy human gastrointestinal tract. Our objective with SER-287 is to develop a first-in-class microbiome therapeutic that modulates the microbiome and microbiome associated metabolites to treat ulcerative colitis. We believe that SER-287 may provide a much needed non-immunosuppressive treatment option for UC. SER-287 is intended to reduce the impact of a dysfunctional microbiome as both a trigger and an amplifier of inflammation. We believe that SER-287 has the potential to be used as both a monotherapy and potentially also in combination with other approved agents. Now to remind you, the 287 Phase 2b ECO-RESET study is a randomized placebo controlled three-arm induction trial that was designed to enroll 201 patients with active mild to moderate ulcerative colitis who have failed prior therapy. In Arm A, patient's receive a short course of vancomycin preconditioning followed by 10 weeks of the same daily regimen that was used in the arm of the previous 1b study that showed the highest clinical remission rate. In Arm B, patients received vancomycin preconditioning followed by two weeks of the same SER-287 daily regimen used in Arm A followed by eight weeks of a lower dose. In Arm C, patients received placebo. As we previously reported, the COVID-19 pandemic has had an impact on our currently enrolling clinical studies, including the SER-287 Phase 2b trial. This study is now over 75% enrolled based on the studies 201 patient target. Our clinical team has implemented a number of mitigation strategies aimed at maintaining forward progress, including providing increased clinical support to trial sites, and additional flexibility regarding data capture. Now moving to our Phase 1b study for SER-401 in our oncology portfolio. SER-401 is an orally administered biologically derived microbiome therapeutic candidate comprising bacteria reflective of the microbiome signature associated with response to checkpoint inhibitor immunotherapy. With SER-01 [ph], we are targeting an increase in efficacy of checkpoint inhibitor immunotherapy and improvement in patient outcome. In collaboration with the Parker Institute for Cancer Immunotherapy, and MD Anderson Cancer Center, we continue to enroll a randomized, placebo controlled Phase 1b study of SER-401 in patients with metastatic melanoma. All patients receive nivolumab and an FDA approved anti-PD-1 therapy and are randomized at a two to one ratio, either SER-401 or placebo. The trial is evaluating the safety, tolerability, and drug activity measured as the engraftment of SER-401 bacteria in the GI tract, and its association with biomarkers of clinical response and outcome. With that, I'll now pass the call to Matt.