Rebiotix and Ferring Pharmaceuticals reported positive preliminary findings from their ongoing pivotal Phase 3 trial of the investigational microbiome-based treatment, RBX2660, under development to reduce C. diff infection recurrences.
PUNCH CD3 is a randomized, multicenter, double-blinded, placebo-controlled study. The 270-patient trial met the primary goal, the percentage of patients receiving the therapy to prevent recurrent C. diff in eight weeks compared to those receiving the placebo. 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 is anticipated in the second half of this year.
RBX2660 has been granted Fast Track, Orphan, and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA).
The investigational RBX2660 formulation is the first-in-class microbiota-based therapy. The human microbiome is a complex community of microorganisms which live on every surface of the body. The microbiome aids in the maintenance and development of the immune system, metabolism, and other functions essential to human life. The gastrointestinal tract houses the most dense and complex population of microbiota, which has an incredible influence over daily health – from aiding in food digestion to fighting disease. Clinical and scientific studies indicate antibiotics, viruses, stress and other factors can disturb the gut microbiota. This disruption, often referred to as “dysbiosis,” may have negative health impacts, and promote conditions for infections like C. diff infection to take hold. Rebiotix and Ferring believe there is tremendous potential in microbiota-based therapies to address such illnesses and are evaluating this therapeutic option through their pioneering microbiota-based MRT™ drug platform, beginning with recurrent C. diff infection.
About Clostridioides difficile infection (C. diff)
C. diff is a bacterium that causes diarrhea and colitis (an inflammation of the colon). It is estimated to cause up to half a million illnesses in the US alone every year and is considered an urgent threat to public health by the CDC, and can lead to severe complications, including hospitalization, surgery, and death. While antibiotics are the standard of care to address the infection, they are also the primary risk factor for disease recurrence.3 Recurrence of C. diff occurs in approximately 15-50% of patients.