Rebiotix + Ferring announce first with positive preliminary pivotal phase III data for investigational microbiome-based therapy RBX2660.

Rebiotix and Ferring Pharmaceuticals announced positive preliminary findings from their ongoing pivotal Phase III trial of the investigational microbiome-based treatment, RBX 2660. These preliminary positive efficacy findings mark an important milestone, advancing RBX 2660 in its clinical development program with a goal of bringing a FDA approved therapy to patients. The clinical development program for RBX 2660 is the most advanced in the world in evaluating the safety and efficacy of a standardized, non-antibiotic microbiome-based therapy.

RBX 2660 is being developed to reduce C. diff infection recurrences, an urgent unmet need for patients and healthcare providers worldwide. Antibiotics, the current standard of care, have been shown to disrupt the microbiome and increase the risk of C. diff recurrence. C. diff causes nearly 30,000 deaths each year in the US and in Europe, the incidence of C. diff is increasing, with recurrent bouts of infection representing 10-15% of all healthcare-related infections in hospitals annually. As a live biotherapeutic, aiming to help restore the gut microbiome community, RBX2 660 may bring an innovative therapeutic option to patients suffering from this potentially deadly infection.

The ongoing Phase III trial is a randomized, multicenter, double-blinded, placebo-controlled study. The trial also incorporates a safety assessment intended to follow patients for several months after receiving the investigational drug. The safety data will provide insight into the potential of using microbes as a therapeutic intervention. The full data package is anticipated in the second half of 2020.