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CAMBRIDGE, Mass.–(BUSINESS WIRE)–Seres Therapeutics, Inc. (Nasdaq:MCRB) today appear that it has enrolled the aboriginal accommodating in its Phase 2B trial, ECO-RESET, evaluating microbiome development applicant SER-287 in patients with alive mild-to-moderate ulcerative colitis. Seres has accustomed $40 actor in anniversary payments associated with this abstraction alpha from Nestlé Health Science.
“Advancing SER-287 into a backward date Phase 2B balloon is a cogent achievement,” said Kevin Horgan, M.D., Executive Vice President and Chief Medical Officer. “We are hopeful that SER-287 may accommodate individuals with ulcerative colitis with a atypical microbiome-based, non-immunosuppressive analysis that addresses the basal anatomy of this austere disease. If this abstraction is successful, we accept the balloon after-effects could accommodate important abutment for allotment of SER-287.”
The SER-287 Phase 2B ECO-RESET abstraction has been advised as a cardinal trial. The Aggregation afresh acquired acknowledgment from the FDA advertence that after-effects from this study, in affiliation with abstracts from a added cardinal study, could accredit a SER-287 Biologics License Application.
The Phase 2B abstraction is a three-arm placebo-controlled balloon of about 200 patients with alive mild-to-moderate ulcerative colitis. Two groups of patients will accept altered doses of SER-287, both afterward pretreatment with a abbreviate advance of articulate vancomycin. A third abstraction arm will accept placebo. The study’s primary endpoint will appraise analytic absolution abstinent afterwards 10 weeks of SER-287 administration. Endoscopic advance will be abstinent as a accessory adeptness measure.
About SER-287SER‐287 is a biologically sourced articulate abridged developed application Seres’ proprietary microbiome analysis platform. The SER-287 Phase 2b study clinicaltrials.gov identifier is NCT03759041. A SER-287 Phase 1b placebo-controlled consecration abstraction in patients with mild-to-moderate alive ulcerative colitis approved a dose-dependent advance of analytic absolution ante and endoscopic array and a favorable tolerability profile.
About Ulcerative ColitisUlcerative colitis is a austere abiding action affecting about 700,000 individuals in the United States. The ache after-effects in deepening of the colon and rectum and can account debilitating symptoms, including belly pain, bowel coercion and diarrhea. Severe cases of ulcerative colitis may aftereffect in surgical abatement of the colon.
About Seres Analysis
Seres Therapeutics, Inc. (Nasdaq:MCRB) is a arch microbiome analysis belvedere aggregation developing a atypical chic of biological drugs that are advised to amusement ache by abating the action of a dysbiotic microbiome, area the accompaniment of bacterial assortment and action is imbalanced. Seres’ advance program, SER-109, has acquired Breakthrough Analysis and Orphan Biologic designations from the U.S. Food and Biologic Administering and is in Phase 3 development for accumulate alternate C. difficile infection. SER-287 is currently actuality evaluated in a Phase 2B abstraction in patients with alive mild-to-moderate ulcerative colitis. Seres is advancing SER-401 to augment the adeptness of immuno-oncology treatment. In addition, the Aggregation has several added microbiome ameliorative candidates in preclinical development for assorted austere diseases. For added information, amuse appointment www.serestherapeutics.com. Follow us on Twitter @SeresTx.
This columnist absolution contains advanced statements aural the acceptation of the Private Securities Litigation Reform Act of 1995. All statements independent in this columnist absolution that do not chronicle to affairs of absolute actuality should be advised advanced statements, including the adeptness of ECO-RESET to abutment SER-287 approval.
These advanced statements are based on management’s accepted expectations. These statements are neither promises nor guarantees, but absorb accepted and alien risks, uncertainties and added important factors that may account our absolute results, achievement or achievements to be materially altered from any approaching results, achievement or achievements bidding or adumbrated by the advanced statements, including, but not bound to, the following: we accept incurred cogent losses, are not currently assisting and may never become profitable; our charge for added funding; our bound operating history; our ambiguous access to ameliorative intervention; the lengthy, expensive, and ambiguous action of analytic biologic development; our assurance on third parties and collaborators to conduct our analytic trials, accomplish our artefact candidates, and advance and commercialize our artefact candidates, if approved; our adeptness to absorb key cadre and to administer our growth; and our administration and arch stockholders accept the adeptness to ascendancy or decidedly access our business. These and added important factors discussed beneath the explanation “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 8, 2018 and our added letters filed with the SE could account absolute after-effects to alter materially from those adumbrated by the advanced statements fabricated in this columnist release. Any such advanced statements represent management’s estimates as of the date of this columnist release. While we may accept to amend such advanced statements at some point in the future, we abandon any obligation to do so, alike if consecutive contest account our angle to change. These advanced statements should not be relied aloft as apery our angle as of any date consecutive to the date of this columnist release.
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