Bacthera, a specialized contract development and manufacturing organization in collaboration with Seres Therapeutics a leading microbiome therapeutics company announced in early November 2021 to manufacture SER-109, an investigational oral microbiome therapeutic evaluated in the Phase 3 ECOSPOR III study to treat recurrent Clostridioides difficile infection (CDI).
Clostridioides difficile is a bacterium that causes an infection of the large intestine affecting 200,000 people annually in the United States imposing a significant burden on the health care system. Symptoms can range from diarrhea to life-threatening inflammatory damage to the colon. Recurrent CDI is associated with antibiotic disruption of colonic microbiota, loss of microbial diversity, and microbe-derived secondary bile acids, usually occurring within 4 weeks of completing antibiotic therapy.
SER-109 is an investigational microbiome drug consisting of bacterial spores enriched from stool donations obtained from healthy, screened donors, designed by Seres Therapeutics. The results obtained in a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study (Phase 3 ECOSPOR III study) showed an absolute decrease of 30.2% in the proportion of patients who experienced a recurrence in CDI within eight weeks of administration versus placebo. Administration of SER-109 was associated with rapid decolonization of antibiotic-resistant bacteria and showed a favorable safety profile.
SER-109 could become the first-ever live biotherapeutic product (LBP) to be produced commercially.
Live biotherapeutic product (LBP)
Live biotherapeutic products (LBPs) represent a revolutionary new class of medicines for which the active substance is a living microorganism, that are currently being developed for multiple indications. LBPs offer a new way to create safe, convenient, and effective treatments for a wide range of diseases as they interact with human biological systems.
LBPs represent a revolutionary microbiome therapeutic option
Bacthera established a new a broad manufacturing site, the Microbiome Center of Excellence located in Visp, Switzerland and dedicated to the production of LBPs. One of the three manufacturing floors will be allocated for producing SER-109.
Lukas Schüpbach, Chief Executive Officer at Bacthera, is passionate about the potential benefits that this life-changing treatment could bring to patients. He says: “We are looking forward to supporting the manufacturing of potentially life-saving microbiome-based treatments, such as SER-109.”
Eric Shaff, Chief Executive Officer at Seres, also pleased to collaborate with Bacthera on SER-109 adds: “Our mission at Seres is to transform the lives of patients worldwide with a potential new treatment option.”