– Investigational therapeutic SER-109 has the potential to change into the first-ever FDA-approved oral microbiome therapeutic –
– Anticipated product launch within the first half of 2023 –
CAMBRIDGE, Mass., September 07, 2022–(BUSINESS WIRE)–Seres Therapeutics, Inc. (Nasdaq: MCRB), a number one microbiome therapeutics firm, at present introduced it has accomplished the rolling submission course of for its Biologics License Utility (BLA) to the U.S. Meals and Drug Administration (FDA) for SER-109 for the prevention of recurrent C. difficile an infection (rCDI). SER-109 is a wholly new remedy modality that exhibits promise to enhance the present commonplace of look after rCDI.
“Finishing this BLA submission marks a key milestone for Seres and, extra importantly, a possible turning level for the remedy of almost 170,000 circumstances of recurrent C. difficile an infection annually in the US alone,” mentioned Lisa von Moltke, MD, Chief Medical Officer at Seres. “We look ahead to persevering with to work with the FDA on the evaluation of this BLA in order that, if accredited, we are able to convey this therapeutic candidate to sufferers as shortly as potential with our collaborator, Aimmune Therapeutics, a Nestlé Well being Science Firm.”
SER-109 has FDA Breakthrough Remedy designation, which offers the potential for precedence evaluation of the BLA. If granted, Seres anticipates the potential approval and launch of SER-109 within the first half of 2023, with SER-109 doubtlessly changing into the primary ever FDA-approved oral microbiome therapeutic.
“After nicely over a decade of analysis, Seres has established robust management within the growth of microbiome therapeutics with a promising pipeline,” mentioned Eric Shaff, President and Chief Govt Officer at Seres. “We’re conducting key pre-commercialization actions, together with market training with acceptable well being care professionals in addition to payer engagement, and we proceed to scale up manufacturing operations to supply SER-109 business provide in preparation for launch.”
The submission is supported by the outcomes of two Section 3 research: ECOSPOR III (NCT03183128) and ECOSPOR IV (NCT03183141). The ECOSPOR III examine was a multicenter, randomized, placebo-controlled examine, outcomes of which have been printed within the New England Journal of Drugs. ECOSPOR III achieved its major endpoint demonstrating that SER-109 was superior to placebo in lowering CDI recurrence at eight weeks, with a sustained medical response charge of roughly 88% at eight weeks post-treatment, in comparison with 60% within the placebo arm. In June 2022, Seres shared confirmatory outcomes from the ECOSPOR IV open-label extension examine, the place the general security profile noticed via 24 weeks indicated that SER-109 was nicely tolerated, in keeping with the security profile noticed within the placebo-controlled ECOSPOR III examine. Additional, ECOSPOR IV topics handled with SER-109 demonstrated a recurrence charge of 8.7% at eight weeks, which signifies a 91.3% sustained medical response.
Seres entered into an settlement with Nestlé Well being Science in July 2021 to collectively commercialize SER-109 within the U.S. and Canada. Below the phrases of the settlement, Nestlé Well being Science will make the most of its international pharmaceutical enterprise, Aimmune Therapeutics, and can assume the function of lead commercialization celebration. Seres has acquired an upfront license fee of $175 million and can obtain an extra $125 million upon FDA approval of SER-109. The settlement additionally contains gross sales goal milestones which, if achieved, would whole as much as $225 million. Seres will probably be liable for growth and pre-commercialization prices within the U.S. Upon commercialization, Seres will probably be entitled to an quantity equal to 50% of the business income.
Constructing upon the confirmed mechanisms of SER-109 inside An infection Safety, Seres is at present evaluating SER-155 in a Section 1b examine in people present process allogeneic hematopoietic stem cell transplantation and at elevated threat of life-threatening infections. Seres can be advancing further preclinical stage packages focusing on An infection Safety and combating the sluggish pandemic of antimicrobial resistant infections extra broadly.
SER-109 is an oral microbiome therapeutic candidate consisting of a consortium of extremely purified Firmicutes spores, which usually dwell in a wholesome microbiome. SER-109 is designed to forestall additional recurrences of CDI by modulating the disrupted microbiome to a state that resists C. difficile colonization and development. The SER-109 manufacturing purification course of is designed to take away undesirable microbes, thereby lowering the chance of pathogen transmission past donor screening alone. The FDA has granted SER-109 Breakthrough Remedy designation and Orphan Drug designation for the prevention of rCDI.
About Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a number one microbiome therapeutics firm creating a novel class of multifunctional bacterial consortia which can be designed to functionally work together with host cells and tissues to deal with illness. Seres’ SER-109 program achieved the first-ever optimistic pivotal medical outcomes for a focused microbiome drug candidate and has obtained Breakthrough Remedy and Orphan Drug designations from the FDA. The SER-109 program is being superior to forestall additional recurrences of C. difficile an infection and has potential to change into a first-in-class FDA-approved microbiome therapeutic. Seres is evaluating SER-155 in a Section 1b examine in sufferers receiving allogeneic hematopoietic stem cell transplantation to cut back incidences of gastrointestinal infections, bloodstream infections and graft-versus-host illness in addition to further preclinical stage packages focusing on An infection Safety in medically compromised sufferers. The Firm can be conducting analysis to tell additional growth of microbiome therapeutics for ulcerative colitis.
For extra info, please go to www.serestherapeutics.com.
This press launch comprises forward-looking statements throughout the that 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 needs to be thought of forward-looking statements, together with the potential approval of SER-109 and its standing as a first-in-class therapeutic; the timing of a BLA acceptance and potential product launch; the potential marketplace for SER-109; the anticipated indication of SER-109; our manufacturing capabilities; and different statements which aren’t historic reality.
These forward-looking statements are based mostly on administration’s present expectations. These statements are neither guarantees nor ensures, however contain recognized and unknown dangers, uncertainties and different necessary elements that will trigger our precise outcomes, efficiency or achievements to be materially totally different from any future outcomes, efficiency or achievements expressed or implied by the forward-looking statements, together with, however not restricted to, the next: we’ve got incurred important losses, will not be at present worthwhile and should by no means change into worthwhile; our want for added funding; our restricted working historical past; the impression of the COVID-19 pandemic; our unproven strategy to therapeutic intervention; the prolonged, costly and unsure means of medical drug growth; our reliance on third events and collaborators to conduct our medical trials, manufacture our product candidates and develop and commercialize our product candidates, if accredited; and our means to retain key personnel and to handle our development. These and different necessary elements mentioned below the caption “Danger Elements” in our Quarterly Report on Kind 10-Q filed with the Securities and Change Fee, or SEC, on August 3, 2022, and our different reviews 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 symbolize administration’s estimates as of the date of this press launch. Whereas we could elect to replace such forward-looking statements sooner or later sooner or later, we disclaim any obligation to take action, even when subsequent occasions trigger our views to vary. 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.
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Carlo Tanzi, Ph.D.