Pfizer’s C. difficile vaccine candidate (PF-06425090) failed to meet the primary endpoint in a Phase 3 trial, the company announced Tuesday. At final analysis, the shot showed just 31% efficacy at preventing infection after three doses, according to a Pfizer press release. Nonetheless, the jab’s 100% efficacy at preventing “medically attended” infection—a secondary endpoint—suggested a possible future direction for the product, Endpoints News reported.
In more promising news, Pfizer’s…
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 therapy for the prevention of recurrent C. difficile infection (CDI) in high-risk patients has met the primary endpoint in a Phase 2 trial, Vedanta Biosciences announced Tuesday. The Massachusetts-based company’s VE303, an orally administered live biotherapeutic, yielded a 31.7% absolute risk reduction in rate of recurrence versus placebo, according to a press release.
Based on the Phase 2 data, the U.S. Biomedical Advanced Research and Development Authority (BARDA) exercised an…
Seres Therapeutics announced last week an agreement with Nestlé Health Science to jointly commercialize SER-109—the Massachusetts-based company’s investigational oral microbiome treatment for recurrent C. difficile infection—in the United States and Canada.
Under the deal, Seres will receive $175 million upfront in license payments, an additional $125 million upon U.S. FDA approval of the treatment, and up to $225 million in milestones. If approved, SER-109 would become the first U.S…
Boston University-led nonprofit CARB-X announced Tuesday that it will give Arizona-based Accelerate Diagnostics $578,000 (plus up to $2.1 million in milestones) to develop a rapid optical imaging diagnostic for sepsis and serious antibiotic-resistant bacterial infections.
In other antimicrobial resistance news, Boston’s Selux Diagnostics announced Tuesday an additional $14.6 million award from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a rapid…
The Access to Medicine (AtM) Foundation last week published a pediatric analysis of additional results from its 2021 AtM Index, finding just 7% of pharmaceutical companies’ R&D is for children under 12, despite significant gaps in treatment options for children.
The report praised GSK, Johnson & Johnson and Sanofi for being “the most active” in developing pediatric versions of products, and also named examples of drugs that “could each make a big difference” for LMICs: Eli…
The U.S. Biomedical Advanced Research and Development Authority (BARDA) announced two awards Wednesday for “advanced development” of investigational drugs targeting antibiotic-resistant infections.
Massachusetts-based Vedanta Biosciences scored up to $76.9 million ($7.4 million upfront) to complete an ongoing Phase 2 trial and continue clinical development of VE303—a novel, human microbiome-derived treatment for high-risk C. difficile infection. The drug becomes the second CARB-X-…
biologics developer Lumen Bioscience announced yesterday that it has raised $16 million in Series B financing to develop its traveler’s diarrhea, norovirus and C. difficile therapies.
The Gates Foundation backed the clinical-stage biotech with funding in 2018 to develop low-cost therapeutics for intestinal pathogens in infants.
CARB-X announced yesterday that it is awarding German biotech Evotec up to $2.9 million (with a potential $5.5 million more in milestone payments) to develop a new class of broad-spectrum antibiotics to treat infections caused by multidrug-resistant Gram-positive and Gram-negative bacteria.
In other antibiotics news this week, Massachusetts-based Seres Therapeutics announced positive topline results from a Phase 3 trial of its oral microbe-based treatment for recurrent C. difficile…