CAMBRIDGE, Mass.–(BUSINESS WIRE)–Mar. 30, 2020– Seres Therapeutics, Inc., (Nasdaq: MCRB) introduced at the moment that the Firm has accomplished enrollment of its SER-109 Section three scientific examine, ECOSPOR III. SER-109 is an oral, first-in-field microbiome therapeutic candidate that has been granted Orphan Drug and Breakthrough Remedy designations by the U.S. Meals and Drug Administration (FDA), and is being investigated to be used in stopping recurrent Clostridium difficile an infection (CDI).
“We’re happy to have achieved this critically vital company milestone. SER-109 has the potential to be the primary FDA-approved remedy for C. difficile an infection to deal with the underlying reason for this illness, and the primary authorized microbiome drug for any human situation. We consider SER-109 may basically rework the therapy of sufferers with recurrent C. difficile an infection, a life-altering infectious illness, and we eagerly look ahead to topline scientific outcomes in the course of this yr. With compelling Section three ECOSPOR III scientific information, we plan to have interaction in discussions with the FDA relating to a submitting for product approval,” stated Eric Shaff, President and Chief Government Officer of Seres. “We’re additionally working to advance our different promising scientific improvement candidates in gentle of the COVID-19 pandemic. This stays an evolving scenario and we’re rigorously reviewing our improvement plans to find out quickly advance our pipeline towards high-quality information readouts.”
SER-109 Examine Updates
The SER-109 Section three ECOSPOR III examine ( identifier: NCT03183128) is a multicenter, randomized, placebo-controlled examine which has enrolled 181 sufferers with multiply recurrent CDI up to now. ECOSPOR III had been designed to enroll 188 sufferers. The Firm has determined to halt enrollment on account of the COVID-19 pandemic. Seres believes that ECOSPOR III stays well-powered to guage the efficacy of SER-109. The ECOSPOR III examine’s main endpoint is the discount of CDI recurrence at as much as eight weeks following SER-109 administration, and the Firm expects to report examine ends in mid-2020 as had been deliberate.
Seres is grateful to the sufferers, principal investigators and scientific analysis groups who participated in ECOSPOR III, lots of whom at the moment are concerned within the battle towards COVID-19.
The SER-109 Section three ECOSPOR III examine consists of use of an goal Clostridium difficile cytotoxin assay to make sure that all sufferers getting into the examine have energetic CDI, in addition to to verify CDI recurrences through the examine (i.e., the ECOSPOR III main endpoint).
Seres plans to provoke a SER-109 Expanded Entry Program at chosen scientific websites collaborating within the ongoing Section three ECOSPOR III examine, and the Firm may provoke this system at extra scientific websites for eligible sufferers to have entry to SER-109.
Prior accomplished scientific research have demonstrated SER-109 bacterial engraftment into the gastrointestinal microbiome, and that engraftment is related to decreased recurrence of CDI. In all prior scientific research, SER-109 was related to a positive security profile.
The FDA has issued a number of security alerts associated to Fecal Microbiota Transplantation (FMT) and the chance of pathogen transmission together with warnings associated to Multi-Drug Resistant Organisms and SARS-CoV-2, the virus linked to COVID-19 (June 12, 2019Alert; March 12, 2020Alert; and March 23, 2020Alert). Unapproved FMT is broadly used underneath an FDA Enforcement Discretion coverage for the therapy of recurrent CDI that isn’t responsive to straightforward therapies.
In distinction to FMT, SER-109 is comprised of a extremely purified consortia of spore-based commensal micro organism and is manufactured underneath Good Manufacturing Practices (GMP) circumstances utilizing stringent requirements to make sure product high quality and consistency. Seres makes use of a novel manufacturing course of which has been demonstrated to inactivate quite a few potential pathogens, together with species of non-spore micro organism, similar to Escherichia coli, and viruses. The Firm’s manufacturing course of inactivates many rising potential pathogens the place diagnostic assays could not but be obtainable, similar to SARS-CoV-2. Seres has issued a place assertion highlighting the criticality of together with pathogen inactivation processes within the manufacture of microbiome therapeutics. Latest discussions with the FDA have indicated company assist relating to the elemental differentiation between FMT and Seres’ product candidates.
COVID-19 Impression and Different Scientific Program Updates
Seres continues to watch the influence of the COVID-19 pandemic on Firm operations and ongoing scientific improvement exercise, together with the SER-287 Section 2b examine in ulcerative colitis, the SER-401 Section 1b examine in metastatic melanoma, and SER-301, a rationally designed, fermented improvement candidate for ulcerative colitis. Mitigation actions to reduce COVID-19-related operation disruptions are ongoing; nonetheless, given the severity and evolving nature of the scenario, the timing of SER-287 Section 2b and SER-401 Section 1b scientific readouts is unsure. Seres doesn’t anticipate disruptions to the provision of its drug product candidates for ongoing research.
The SER-287 Section 2b examine is at present roughly 60% enrolled based mostly on the 201-patient goal examine dimension. SER-287 improvement exercise has been adversely impacted by a number of scientific websites halting non-essential procedures, together with endoscopies, which can make it tough to attain the unique enrollment goal in H2 2020 as deliberate. Seres is evaluating enrollment mitigation methods and attainable trial design modifications with the objective of acquiring a high-quality, clinically significant dataset inside a timeframe per Seres’ prior steering for its money runway extending into the second quarter of 2021. Moreover, the Firm is inspired by the FDA’s indications of flexibility in gentle of the COVID-19 pandemic, and plans to have interaction the FDA in discussions relating to any potential trial modifications.
Seres continues to execute on actions to advance SER-301 scientific improvement and the deliberate initiation of affected person dosing in Australia and New Zealand later this yr.
About Seres Therapeutics
Seres Therapeutics, Inc., (Nasdaq: MCRB) is a number one microbiome therapeutics platform firm creating a novel class of organic medication which are designed to deal with illness by restoring the operate of a dysbiotic microbiome, the place the state of bacterial range and performance is imbalanced. Seres’ SER-287 program has obtained Quick Monitor and Orphan Drug designation from the U.S. Meals and Drug Administration and is being evaluated in a Section 2b examine in sufferers with energetic mild-to-moderate ulcerative colitis. Seres’ SER-109 program has obtained Breakthrough Remedy and Orphan Drug designations from the FDA and is in Section three improvement for recurrent C. difficile an infection. Seres can also be creating SER-401 in a Section 1b examine in sufferers with metastatic melanoma and SER-301 for ulcerative colitis. For extra info, please go to
This press launch incorporates forward-looking statements inside the which means of the Personal Securities Litigation Reform Act of 1995. All statements contained on this press launch that don’t relate to issues of historic reality ought to be thought-about forward-looking statements, together with statements regarding FDA approval of Seres’ therapeutic candidates, the timing and outcomes of ECOSPOR III and any of our different scientific research, the promise of microbiome therapeutics usually, the influence of the COVID-19 pandemic, the potential flexibility of the FDA with regard to our scientific trials, the anticipated minimal influence of the decreased trial dimension in ECOSPOR III, and the protection and purity of our product candidates. Any forward-looking statements signify administration’s opinions as of the date of this press launch. Whereas we could elect to replace such forward-looking statements in some unspecified time in the future sooner or later, we disclaim any obligation to take action, even when subsequent occasions trigger our views to alter. These forward-looking statements shouldn’t be relied upon as representing our views as of any date subsequent to the date of this press launch.
These forward-looking statements are based mostly on administration’s present expectations. These statements are neither guarantees nor ensures, however contain identified and unknown dangers, uncertainties and different vital elements that will trigger our precise outcomes, efficiency or achievements to be materially completely different from any future outcomes, efficiency or achievements expressed or implied by the forward-looking statements, together with, however not restricted to, the next: the unknown influence of COVID-19; we’ve incurred important losses, usually are not at present worthwhile and should by no means grow to be worthwhile; our want for extra funding; our unproven method to therapeutic intervention; our reliance on third events and collaborators to conduct our scientific trials, manufacture our product candidates and develop and commercialize our product candidates, if authorized; that we’ve no expertise manufacturing merchandise at industrial scale; our merchandise could grow to be topic to unfavorable pricing restrictions; we could face product legal responsibility lawsuits; we could face competitors from biosimilars; our potential to guard our commerce secrets and techniques and know-how; potential adjustments in U.S. patent regulation; and the chance of third get together lawsuits alleging we’re infringing on their mental property. These and different vital elements mentioned underneath the caption “Danger Elements” in our Annual Report on Kind 10-Okay filed with the Securities and Trade Fee, or SEC, on March 2, 2020 and our Present Report on Kind 8-Okay filed with the SEC on March 18, 2020, and our different studies filed with the SEC may trigger precise outcomes to vary materially from these indicated by the forward-looking statements made on this press launch. Any such forward-looking statements signify administration’s estimates as of the date of this press launch. Whereas we could elect to replace such forward-looking statements in some unspecified time in the future sooner or later, we disclaim any obligation to take action, even when subsequent occasions trigger our views to alter. These forward-looking statements shouldn’t be relied upon as representing our views as of any date subsequent to the date of this press launch.
Supply: Seres Therapeutics, Inc.
Posted: March 2020