Seres Therapeutics Receives Award of Up to $3.6 Million from CARB-X to Develop Liquid Formulation of SER-155
Seres Therapeutics (Nasdaq: MCRB) received up to $3.6 million in non-dilutive funding from CARB-X to develop and manufacture an oral liquid formulation of SER-155 for medically vulnerable patients who cannot take capsules, including intubated ICU patients.
SER-155, developed for allo-HSCT patients, showed a 77% reduction in bacterial bloodstream infections (BSIs) versus placebo in a randomized Phase 1b study and reduced systemic antibiotic use and febrile neutropenia. The company received constructive FDA feedback on a well-powered Phase 2 design and is finalizing the clinical protocol.
Seres Therapeutics (Nasdaq: MCRB) ha ricevuto fino a 3,6 milioni di dollari in finanziamenti non diluitivi da CARB-X per sviluppare e produrre una formulazione liquida orale di SER-155 per pazienti medici vulnerabili che non possono assumere capsule, inclusi i pazienti intubati in terapia intensiva.
SER-155, sviluppato per pazienti allo-HSCT, ha mostrato una riduzione del 77% delle infezioni batteriche del sangue (BSI) rispetto al placebo in uno studio randomizzato di fase 1b e ha ridotto l'uso di antibiotici sistemici e la neutropenia febbrile. L'azienda ha ricevuto feedback costruttivi dalla FDA su un disegno di fase 2 ben potenziato ed è in fase di finalizzazione del protocollo clinico.
Seres Therapeutics (Nasdaq: MCRB) recibió hasta 3,6 millones de dólares en financiamiento no dilutivo de CARB-X para desarrollar y fabricar una formulación líquida oral de SER-155 para pacientes médicamente vulnerables que no pueden tomar cápsulas, incluidos los pacientes intubados en UCI.
SER-155, desarrollado para pacientes allo-HSCT, mostró una reducción del 77% de infecciones bacterianas de la sangre (BSI) frente a placebo en un estudio aleatorio de fase 1b y redujo el uso de antibióticos sistémicos y la neutropenia febril. La empresa recibió comentarios constructivos de la FDA sobre un diseño de fase 2 bien potenciado y está finalizando el protocolo clínico.
Seres Therapeutics (Nasdaq: MCRB)는 카르브-X로부터 섭취 가능한 정제 캡슐을 복용할 수 없는 중증 취약 환자를 위한 SER-155의 경구 액체 제형 개발 및 제조를 위해 최대 360만 달러의 비희석 자금을 받았습니다.
SER-155는 allo-HSCT 환자를 위해 개발되었으며 무작위 배정 1b상에서 혈류 세균 감염(BSI)을 위약 대비 77% 감소시켰고 전신 항생제 사용 및 발열성 호중구감소증을 감소시켰습니다. 회사는 충분한 파워를 가진 2상 설계에 관해 FDA로부터 건설적인 피드백을 받았고 임상 프로토콜을 확정 중입니다.
Seres Therapeutics (Nasdaq : MCRB) a reçu jusqu'à 3,6 millions de dollars de financement non dilutif de CARB-X pour développer et fabriquer une formulation liquide orale de SER-155 destinée aux patients médicalement vulnérables qui ne peuvent pas prendre de gélules, y compris les patients intubés en unités de soins intensifs.
SER-155, développé pour les patients allo-HSCT, a montré une réduction de 77% des infections sanguines bactériennes (BSI) par rapport au placebo dans une étude randomisée de phase 1b et a réduit l'usage systémique d'antibiotiques et la neutropénie fébrile. La société a reçu des retours constructifs de la FDA sur une conception de phase 2 bien conçue et finalise le protocole clinique.
Seres Therapeutics (Nasdaq: MCRB) erhielt von CARB-X bis zu 3,6 Millionen US-Dollar an nicht dilutive Finanzierung, um eine orale flüssige Formulierung von SER-155 für medizinisch verwundbare Patienten zu entwickeln und herzustellen, die keine Kapseln einnehmen können, einschließlich intubierter ICU-Patienten.
SER-155, entwickelt für allo-HSCT-Patienten, zeigte eine Reduktion um 77% bakterieller Blutbahninfektionen (BSIs) im Vergleich zu Placebo in einer randomisierten Phase-1b-Studie und reduzierte den systemischen Antibiotikaeinsatz sowie fieberhafte Neutropenie. Das Unternehmen erhielt konstruktives Feedback der FDA zu einem gut gepowerten Phase-2-Design und finalisiert das klinische Protokoll.
Seres Therapeutics (Nasdaq: MCRB) تلقت حتى 3.6 مليون دولار من تمويل غير مخفّض من CARB-X لتطوير وتصنيع صيغة سائلة فموية لـ SER-155 لمرضى معرضين للخطر طبيًا لا يستطيعون تناول الكبسولات، بما في ذلك مرضى العناية المركزة الذين خضعوا للتنبيب.
SER-155، المطوّرة لمرضى allo-HSCT، أظهرت انخفاضاً قدره 77% في عدوى الدم البكتيرية (BSI) مقارنة بالدواء الوهمي في تجربة عشوائية من المرحلة 1b وأقللت استخدام المضادات الحيوية النظامية والحمّى المحببية. تلقت الشركة ملاحظات بناءة من FDA حول تصميم المرحلة 2 القوي وتقوم حاليًا بوضع البروتوكول السريري النهائي.
Seres Therapeutics (纳斯达克: MCRB) 从 CARB-X 获得多达 360 万美元 的非稀释性资金，用于开发和制造 SER-155 的口服液体制剂，面向不能吞咽胶囊的医疗脆弱患者，包括在 ICU 进行气管插管的患者。
SER-155 为 allo-HSCT 患者开发，在一项随机的 1b 期研究中，与安慰剂相比，血流感染（BSI）降低了 77%，并减少了全身性抗生素使用和发热性中性粒细胞减少症。公司就一个功效充足的 2 期设计获得了 FDA 的建设性反馈，正在最终确定临床方案。
- $3.6M in additional non-dilutive CARB-X funding
- Phase 1b: 77% reduction in bacterial BSIs vs placebo
- SER-155 remains investigational with no FDA approval; Phase 2 protocol is being finalized
Liquid formulation has potential to expand patient access, including those in intensive care, to SER-155 for the prevention of bloodstream and antimicrobial resistant (AMR) infections
CAMBRIDGE, Mass., Oct. 29, 2025 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading live biotherapeutics company, today announced that CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global non-profit partnership accelerating antibacterial products to address drug-resistant bacteria, a leading cause of death around the world, will provide up to
SER-155 is being developed for patients receiving allogeneic hematopoietic stem cell transplants (allo-HSCT), a population that is particularly susceptible to severe infections due to prolonged immunosuppression. In a randomized, placebo-controlled Phase 1b study evaluating SER-155 in this patient population, SER-155 reduced bacterial BSIs by
“We have deeply appreciated CARB-X’s long-standing partnership with Seres in advancing the SER-155 program and are grateful for their continued support,” said Matthew Henn, Ph.D., Chief Scientific Officer “We have been encouraged by the compelling SER-155 clinical data to date, including data showing the potential of SER-155 to reduce the frequency of BSIs and also lessen reliance on antibiotics in allo-HSCT patients. Developing a liquid formulation will improve accessibility for patients who cannot take capsules, such as those in intensive care, providing an opportunity to potentially broaden impact of the program in additional patient populations at high risk of BSIs and AMR infections.”
“CARB-X is pleased to continue supporting Seres in the development of SER-155,” said Kevin Outterson, Executive Director of CARB-X. “The program represents an innovative approach to preventing serious bacterial infections in high-risk patients. Developing a liquid formulation could help expand access for those who cannot take capsules, which is an important consideration in the ICU patient population.”
Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided by federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), the UK Department of Health and Social Care as part of the Global Antimicrobial Resistance Innovation Fund (GAMRIF), and the Novo Nordisk Foundation. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.
About CARB-X
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. CARB-X funds only projects that target the most serious, resistant bacteria identified on global priority lists, syndromes with the greatest global morbidity and mortality, and performance characteristics necessary for patients. Website: www.carb-x.org/ | X (formerly Twitter) @CARB_X
About Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through novel live biotherapeutics. Seres led the successful development and approval of VOWST™, the first FDA-approved orally administered microbiome therapeutic, which was sold to Nestlé Health Science in September 2024. The Company is developing SER-155, which has received Breakthrough Therapy designation for the reduction of bloodstream infections in adults undergoing allo-HSCT and Fast Track designation for reducing the risk of infection and graft-versus-host disease in adults undergoing allo-HSCT, and which has demonstrated a significant reduction in bloodstream infections and related complications (as compared to placebo) in a Phase 1b clinical study in patients undergoing allo-HSCT. SER-155 and the Company's other pipeline programs are designed to target multiple disease-relevant pathways and are manufactured from standard clonal cell banks via cultivation, rather than from the donor-sourced production process used for VOWST. In addition to allo-HSCT, the Company intends to evaluate SER-155 and other cultivated live biotherapeutic candidates in other medically vulnerable patient populations including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, as well as patients in the intensive care unit and long-term acute care facilities. For more information, please visit www.serestherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements about: t the CARB-X funding and its intended uses and benefits; potential accessibility for patients; the timing and results of our clinical studies and data readouts; current or future product candidates and their potential benefits; clinical development plans and commercial opportunities; communications with, feedback from, or submissions to, the FDA; our plans and expectations regarding the design and finalization of a Phase 2 study of SER-155; our clinical development plans for SER-155, including the development of a liquid formulation, and other cultivated live biotherapeutic candidates across medically vulnerable populations; the anticipated timing of any of the foregoing; and other statements that are not historical fact.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: (1) our need for additional funding; (2) our ability to continue as a going concern; (3) we have incurred significant losses, are not currently profitable and may never become profitable; (4) our cost reduction actions may not achieve their intended benefits, including an extended cash runway; (5) our limited operating history; (6) the expected payments from the VOSWT sale are subject to risks and uncertainties; (7) we may not be able to realize the anticipated benefits of the VOWST sale, and may face new challenges as a smaller, less diversified company; (8) we have in the past and may in the future receive notice of the failure to satisfy a continued listing rule from The Nasdaq Stock Market LLC; (9) our novel approach to therapeutic intervention; (10) our reliance on third parties to conduct our clinical trials and manufacture our product candidates; (11) our ability to achieve market acceptance necessary for commercial success; (12) the competition we will face; (13) our ability to protect our intellectual property; and (14) our ability to manage our recent CEO transition, to retain key personnel and to manage our growth. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 6, 2025, as well as our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Investor and Media Contact:
IR@serestherapeutics.com
Carlo Tanzi, Ph.D.
Kendall Investor Relations
ctanzi@kendallir.com
FAQ
What funding did Seres (MCRB) receive on October 29, 2025 for SER-155?
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Who is funding Seres’ SER-155 liquid formulation development besides CARB-X?
