Seres Therapeutics has received the US Food and Drug Administration (FDA) breakthrough therapy designation for SER-155, the company’s lead investigational programme.
SER-155 aims to reduce bloodstream infections (BSIs) in adults undergoing allogeneic haematopoietic stem cell transplants (allo-HSCT) for the treatment of haematological malignancies.
The drug candidate is Seres Therapeutics’ second programme to receive the breakthrough therapy designation.
This designation provides access to FDA senior management and ensures close collaboration for expedited drug development.
In December 2023, SER-155 also received FDA fast track designation for reducing infection and graft-versus-host disease (GVHD) risks in allo-HSCT patients.
Seres Therapeutics president and CEO Eric Shaff said: “We are thrilled that the FDA has granted Breakthrough Therapy designation to SER-155, underscoring the strength of our Phase 1b clinical data and the potential of this live biotherapeutic candidate to address one of the most significant complications faced by patients undergoing allo-HSCT.
“We are excited to advance the development of SER-155, working diligently to bring this innovative therapeutic to patients in need, while also exploring its potential use in other high-risk patient populations to maximise its impact.”
In September this year, Seres Therapeutics revealed topline clinical data from Cohort 2 of its SER-155 Phase 1b placebo-controlled trial in patients undergoing allo-HSCT.
The data showed that the investigational programme significantly reduced BSIs by 77%.
It also demonstrated a significant reduction in systemic antibiotic exposure, and lower incidence of febrile neutropenia, in each case as compared to placebo, through day 100 post-HSCT.
In addition, the asset was well-tolerated, with no treatment-related serious adverse events.
Seres Therapeutics plans to expand the development of SER-155 and other pipeline candidates for autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, and those in intensive care or long-term acute care.
The Nasdaq-listed drugmaker is also actively seeking a partner to provide financial resources and expertise to maximise the SER-155 programme while maintaining a capital-efficient development strategy.
Additionally, the company successfully developed and gained FDA approval in April 2023 for Vowst, an orally administered microbiome therapeutic to prevent the recurrence of Clostridioides difficile Infection (CDI).
In September 2024, Seres Therapeutics sold Vowst to Nestlé Health Science.
