Seres Therapeutics Receives Breakthrough Therapy Designation for SER-155

Seres Therapeutics has announced the regulatory approval of SER-155, a treatment aimed at reducing bloodstream infections (BSIs) in adults undergoing allogeneic haematopoietic stem cell transplant (allo-HSCT) as part of their therapy for haematological malignancies.

SER-155 is an investigational oral live biotherapeutic designed to target gastrointestinal (GI) pathogens, enhance epithelial barrier function, and promote immune tolerance. It prevents bacterial bloodstream infections, antimicrobial resistance (AMR)-related complications, and other adverse clinical outcomes associated with pathogens in allo-HSCT patients.

The efficacy of SER-155 has been assessed in a Phase 1b placebo-controlled trial involving patients undergoing allo-HSCT. The study revealed significant reductions in BSIs, systemic antibiotic use, and the incidence of febrile neutropenia.

The treatment has been granted breakthrough therapy designation for its role in reducing BSIs and fast track designation for its potential to lower the risk of infections and graft-versus-host disease (GvHD) in HSCT patients.

BSIs are a frequent, severe, and potentially fatal complication in allo-HSCT patients. Current clinical practise involves aggressive management with broad-spectrum antibiotics for those experiencing BSIs or febrile neutropenia, as infections are among the leading causes of mortality in the first 100 days post-transplant. However, while antibiotic prophylaxis is commonly used, it does not address the root cause of these infections, a gap SER-155 aims to fill.

Beyond allo-HSCT, BSIs are a serious concern for various medically vulnerable groups, including patients undergoing autologous-HSCT, cancer patients with neutropenia, CAR-T therapy recipients, individuals with chronic liver disease, solid organ transplant recipients, and those in intensive care or long-term acute care settings. Seres Therapeutics plans to extend the development of SER-155 and other pipeline products to address these populations, which collectively represent significant commercial opportunities.

The US FDA has granted breakthrough therapy designation to Seres Therapeutics' SER-155 for reducing bloodstream infections in adults undergoing allogeneic haematopoietic stem cell transplants (allo-HSCT).

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