Seres Therapeutics’ oral microbiome treatment for C. difficile infections (CDI) proved superior to placebo in reducing CDI recurrence, according to Phase 3 data published last week in the New England Journal of Medicine. Touting the “first-ever positive pivotal clinical results for a targeted microbiome drug,” the Massachusetts-based company said in a press release it would finalize its U.S. FDA Biologics License Application for SER-109 in mid-2022.
The treatment boasts FDA…
Promising C. difficile drug ridinilazole has failed in Phase 3, CARB-X grantee Summit Therapeutics announced Monday.
The Massachusetts-based company said the study showed that the investigational drug resulted in a higher observed Sustained Clinical Response rate than current standard-of-care vancomycin “but did not meet the study’s primary endpoint for superiority.”
The company did see a “meaningful reduction in recurrence,” however, which Summit Therapeutics linked to the…
A novel, temperature-stable, cholera toxin B (CTB) subunit vaccine candidate made of powdered, genetically modified Japanese short-grain rice produced no obvious side effects and generated a “good immune response” in a Phase 1 trial, the University of Tokyo announced last week.
Volunteers who responded to MucoRice-CTB showed increased CTB-specific antibodies in a “gut microbiota-dependent manner,” and those receiving a higher dose were more likely to have CTB-specific antibodies,…
CARB-X announced Tuesday that it will give Swiss biopharma BioVersys up to $4.3 million (plus up to $11 million in milestones) to develop new antibiotics to treat life-threatening infections caused by multidrug-resistant “ESKAPE” pathogens, including E. faecium, S. aureus, K. pneumoniae, A. baumannii, P. aeruginosa and Enterobacter species.
BioVersys’ novel class of pyrrolocytosine small molecules have exhibited “robust coverage” of all relevant Gram-negative pathogens as well as other…
Evolve BioSystems announced observational study results on Tuesday showing that preterm infants fed its activated B. infantis probiotic (EVC001) had a “significantly lower level of intestinal inflammation, 62% less diaper rash, and required 62% fewer antibiotics.” Frontiers in Pediatrics published the results.
Evolve also reported last week that it has raised $55 million in Series D financing, led by food products group Cargill and investment firm Manna Tree. The California microbiome…
San Francisco–based microbial genomics company uBiome announced last week that it is expanding into therapeutics, has won $83 million in new investment, and is adding former Novartis CEO Joe Jimenez as a board member.
The company is opening a facility in Cambridge, Massachusetts to mine its database of diagnostic microbiome tests for new therapeutic targets. uBiome will focus initially on oncology, autoimmune disease, obesity and metabolic disorders, the company said.
Merck KGaA’s MilliporeSigma business announced a two-year collaboration today with Washington University in St. Louis to use CRISPR genome-editing technology to understand better microbes’ functions and nutritional needs.
MilliporeSigma CEO Udit Batra said the collaboration “will focus on how to repair and reconstitute a normal microbiome in malnourished children.”