Phase III PUNCH CD3 trial of RBX 2660 meets primary endpoint in C. difficile Infection.- Ferring Pharmaceuticals and Rebiotix

The trial successfully met its primary endpoint. RBX 2660 demonstrated superior efficacy versus placebo (70.4% and 58.1%, respectively) at 8 weeks post treatment, with a comparable safety profile to placebo. RBX 2660 results demonstrated statistical significance with a 98.6% posterior probability of superiority, which exceeded the 97.5% minimum threshold. In addition to these outcomes, RBX 2660 provided a relative reduction of recurrence of 29.4% compared to placebo. The majority of treatment emergent adverse events (TEAEs) for RBX 2660 were similar to placebo, and mild to moderate in nature. These data add to the large body of evidence showing consistent efficacy and safety in patients who have received RBX 2660, which may help address the unmet need for patients who suffer from this debilitating and potentially deadly recurrent infection. RBX 2660 is an investigational, potential first-in-class microbiota-based live biotherapeutic. The trial has been presented at Digestive Disease Week (DDW) 2021.