Four years later, Ferring’s fecal microbiota transplant, dubbed RBX2660 or Rebyota, will face the FDA’s adcomm of outside vaccine experts on Sept. 22, debating whether the agency should license the transplant as a treatment for adults following antibiotic treatment for recurrent C. difficile infection.
PARSIPPANY, New Jersey - ( BUSINESS WIRE ) - Ferring presents comprehensive data from five trials of RBX2660 demonstrating uniform and long-lasting efficacy in recurrent C. Difficile infection , as well as multiple analyzes demonstrating positive changes in microbiome characteristics
Saint-Prex, Switzerland, and Roseville, MN, USA – May 13, 2021 – Ferring Pharmaceuticals and Rebiotix, a Ferring Company, today announced that Phase 3 data evaluating its investigational microbiota-based live biotherapeutic RBX2660 for reduction of recurrent Clostridioides difficile (C. difficile) infection will be presented as part of an invited talk at Digestive Disease Week® (DDW) 2021. The congress will take place virtually from May 21-23, 2021.
ST PREX, Switzerland & ROSEVILLE, Minn. & ROHOVOT, Israel--(BUSINESS WIRE)--Ferring Pharmaceuticals, Rebiotix Inc., a Ferring Company, and MyBiotics Pharma Ltd. today announced a multi-year strategic collaboration to develop live microbiota-based biotherapeutics to address bacterial vaginosis, a common vaginal infection among women of reproductive age linked to increased risk of miscarriage and complications for pregnancy and fertility.1,2,3 The collaboration is an important step forward in harnessing the power of the human microbiome in this area of women’s health.
Several years ago, as companies capitalizing on science that suggests flushing ‘good’ gut bacteria into the system can treat a plethora of conditions — from C. diff infections to obesity — began to gain traction, the opportunities to harness the microbiome garnered feverish promise and generous funding. Then, in 2016, Seres Therapeutics’ failure in a mid-stage trial evaluating its “crapsule” — donor-derived processed fecal material encapsulated in a pill — derailed the emerging field, relegating the microbiome from hero to zero status.
ROSEVILLE, Minn. & SAINT-PREX, Switzerland--(BUSINESS WIRE)--Today, Rebiotix and Ferring Pharmaceuticals announced positive preliminary findings from their ongoing pivotal Phase 3 trial of the investigational microbiome-based treatment, RBX2660. These preliminary positive efficacy findings mark an important milestone, advancing RBX2660 in its clinical development program with a goal of bringing a US FDA approved therapy to patients. The clinical development program for RBX2660 is the most advanced in the world in evaluating the safety and efficacy of a standardized, non-antibiotic microbiome-based therapy.
Rebiotix, a Ferring company, announced today that it has completed enrollment of the pivotal Phase 3 clinical trial for RBX2660, an investigational therapy aimed at breaking the cycle of recurrent Clostridioides difficile (C. diff) infection, which is responsible for the deaths of thousands of people in the US alone. The Centers for Disease Control and Prevention (CDC) has classified C. diff as an urgent public health threat, with limited options for treatment.